GB2549098A

GB2549098A - Safety assessment method and apparatus

Info

Publication number: GB2549098A
Application number: GB1605681.4A
Authority: GB
Inventors: Boughton Ray
Original assignee: Delphic Hse Solutions Ltd
Current assignee: Delphic Hse Solutions Ltd
Priority date: 2016-04-04
Filing date: 2016-04-04
Publication date: 2017-10-11
Also published as: WO2017174974A1

Abstract

A method for generating a product information document including the results of a safety assessment comprises the steps of acquiring, by a processor, a product ingredients list; acquiring, for one or more ingredients in the ingredients list, a value of an amount of that ingredient used by a user of the product in a time period; acquiring values of at least one physical property of the user, such as dermal absorption; using the value of the amount of the ingredient used in the time period and the one or more physical properties to determine one or more exposure values indicative of an exposure of the user to that ingredient during the time period; performing a safety assessment based on the determined one or more exposure values; and generating a product information file including the results of the safety assessment. The safety assessment may comprise determining a margin of safety (MOS) for an ingredient by dividing a no observed adverse effect level (NOAEL) by a systemic exposure dose (SED) for that ingredient. The MOS can be provided as a label on products such as cosmetics, pharmaceuticals, toiletries and food.

Description

SAFETY ASSESSMENT METHOD AND APPARATUS

FIELD OF THE INVENTION

The present invention relates to safety assessments including methods and apparatus for performing product safety assessments.

BACKGROUND

Throughout the world, many regulatory bodies have established codes and rules under which manufacturers and/or distributors of certain products, including but not limited to cosmetics and medicaments, are required to notify or warn the public of known adverse events which could occur during the use of certain products by a consumer.

Moreover, in many cases, if the requisite warnings are not present, the product or device must be immediately removed from use by, and availability to, the public. Significant fines and penalties may also be levied against the manufacturer and/or distributor of the product for its failure to provide adequate warning to the public. In addition, manufacturers and/or distributors risk criminal and/or civil liability to anyone adversely affected by the product or device while it was on the market.

Thus, there is a need a for reliable screening method to eliminate or minimise the possibility of an adverse effect on a user using a product, so that the user can trust that the product or device is “safe”, and that also ensures users are adequately warned of potential adverse effects of using the product.

SUMMARY OF THE INVENTION

In a first aspect the present invention provides a method for generating a product information document, report, or file etc. for a product. The method comprises: acquiring, by one or more processors, a product ingredient list for the product; acquiring, by the one or more processors, for one or more ingredients in the ingredient list, a value of an amount of that ingredient used by a user of the product in a time period; acquiring, by the one or more processors, for one or more physical properties of the user, a value of that physical property of the user; for the one or more ingredients in the ingredient list, using the value of the amount of that ingredient used by a user of the product in the time period and the one or more physical property values, determining, by the one or more processors, one or more exposure values, each exposure value being indicative of an exposure of the user to that ingredient during the time period; performing, by the one or more processors, a safety assessment based on the determined one or more exposure values; and generating, by the one or more processors, a product information file including the results of the safety assessment.

The method may further comprise acquiring, by the one or more processors, a value of an amount of the product used by the user of the product in the time period. Acquiring the value of the amount of an ingredient used by the user of the product in the time period may comprise determining, by the one or more processors, the amount of that ingredient used by the user of the product in the time period based on the amount of the product used by the user of the product in the time period and the product ingredient list.

Determining the amount of an ingredient used by the user of the product in the time period may comprise using the amount of the product used by the user of the product in the time period and a proportion of that ingredient in the product, the proportion of that ingredient in the product being specified in the product ingredient list.

The method may further comprise: displaying, by a display operatively coupled to the one or more processors, a plurality of different product types; and receiving, by the one or more processors, a selection of a product type from the plurality of different product types. Acquiring the value of the amount of the product used by the user of the product in the time period may be based on the selected product type.

The method may further comprise: displaying, by a display operatively coupled to the one or more processors, a plurality of different user types; and receiving, by the one or more processors, a selection of a user type from the plurality of different user types. Acquiring the value of a physical property of the user is may be based on the selected user type.

Acquiring the value of the amount of the product used by the user of the product in the time period may be based on the selected product type and the selected user type.

The one or more physical properties of the user may include a mass of the user.

The one or more physical properties of the user may include a dermal absorption of the user.

The one or more exposure values for an ingredient may include a systemic exposure dose (SED) for that ingredient. The SED for an ingredient may be determined in terms of volume of that ingredient used by the user per unit mass of the user per day. The product information file may include at least one determined SED.

The method may further comprise, acquiring, by the one or more processors, for one or more ingredients in the ingredient list, a no observed adverse effect level (NOAEL) for that ingredient. The safety assessment may be based on the acquired one or more NOAELs.

The safety assessment may comprise determining, by the one or more processors, for one or more ingredients, a Margin of Safety (MOS) value for that ingredient. The MOS for an ingredient may be determined based on a no observed adverse effect level (NOAEL) for that ingredient and a systemic exposure dose (SED) for that ingredient. Determining the MOS for an ingredient may comprise dividing the NOAEL for that ingredient by the SED for that ingredient. The product information file may include at least one determined MOS. The safety assessment may comprise: acquiring, by the one or more processors, for one or more ingredients, a threshold for the MOS for that ingredient; and comparing, by the one or more processors, for one or more ingredients, the MOS for that ingredient to the acquired MOS threshold for that ingredient. The safety assessment may comprise assigning, by the one or more processors, to one or more of the ingredients, a safety label depending on the comparison of the MOS for that ingredient to the acquired MOS threshold for that ingredient. A first safety label may be assigned to an ingredient if the MOS for that ingredient is less than or equal to the MOS threshold for that ingredient. A second safety label may be assigned to an ingredient if the MOS for that ingredient is greater than the MOS threshold for that ingredient. The first safety label may indicate an unsafe ingredient. The second safety label may indicate a safe ingredient.

For one or more ingredients, the MOS threshold for that ingredient may be 100. For one or more ingredients, the MOS threshold for that ingredient may be greater than 100. For one or more ingredients, the MOS threshold for that ingredient may be less than 100. For one or more ingredients, the MOS threshold for that ingredient may be 10. For one or more ingredients, the MOS threshold for that ingredient may be in the range 1 to 10. For one or more ingredients, the MOS threshold for that ingredient may be 1.

Acquiring an MOS threshold may comprise: acquiring, by the one or more processors, an interspecies variability factor; and determining, by the one or more processors, the MOS threshold using the interspecies variability factor. The interspecies variability factor may be between 1 and 10.

Acquiring an MOS threshold may comprise: acquiring, by the one or more processors, an intraspecies variability factor; and determining, by the one or more processors, the MOS threshold using the intraspecies variability factor. The intraspecies variability factor may be between 1 and 10.

The one or more physical properties of the user may include a surface area of at least part of the user.

The method may further comprise: displaying, by a display operatively coupled to the one or more processors, one or more different use scenarios for the product, each use scenario specifying one or more body parts of the user; and receiving, by the one or more processors, a selection of a use scenario from the plurality of different use scenarios. Acquiring the value of a physical property of the user may comprise acquiring a value of a surface area of at least part of the user based on the selected use scenario.

The method may further comprise providing a plurality of different use scenarios, each use scenario in the plurality of use scenarios corresponding to a respective one or more different product types. The displayed use scenarios may be only those use scenarios that correspond to the selected product type.

Acquiring a value of a surface area of at least part of the user may be based on the selected use scenario and based on the selected user type.

The one or more exposure values for an ingredient may include a skin exposure value for that ingredient, the skin exposure value for an ingredient being indicative of an amount of that ingredient per unit of area of the user’s skin is that exposed to that ingredient within the time period.

The skin exposure value for an ingredient may be determined in terms of milligrams of that ingredient used by the user per square-centimetre of skin of the user to which that ingredient is applied per day.

The product information file may include at least one determined skin exposure value for an ingredient.

The method may further comprise, acquiring, by the one or more processors, for one or more ingredients in the ingredient list, a local no observed adverse effect level (NOAEL) for that ingredient, a local NOAEL for an ingredient being a NOAEL for that ingredient for an area of a user’s skin. The safety assessment may be based on the acquired one or more local NOAELs.

The safety assessment may comprise determining, by the one or more processors, a safety value for that ingredient, a safety value for an ingredient being the local NOAEL for that ingredient and the skin exposure value for that ingredient. Determining the safety value for an ingredient may comprise dividing the local NOAEL for that ingredient by the skin exposure value for that ingredient. The product information file may include at least one determined safety value. The safety assessment may comprise: acquiring, by the one or more processors, for one or more ingredients, a threshold for the safety value for that ingredient; and comparing, by the one or more processors, for one or more ingredients, the safety value for that ingredient to the acquired safety value threshold for that ingredient. The safety assessment may further comprise assigning, by the one or more processors, to one or more of the ingredients, a safety label depending on the comparison of the safety value for that ingredient to the acquired safety value threshold for that ingredient. A third safety label may be assigned to an ingredient if the safety value for that ingredient is less than or equal to the safety value threshold for that ingredient. A fourth safety label may be assigned to an ingredient if the safety value for that ingredient is greater than the safety value threshold for that ingredient. The third safety label may indicate an unsafe ingredient. The fourth safety label may indicate a safe ingredient.

The method may further comprise: providing a list of allergens; and identifying, by the one or more processors, using the product ingredient list, each allergen in the product. The product information file may include a list of identified allergens in the product. The method may further comprise: acquiring, by the one or more processors, a threshold amount for each allergen present in the product; generating a warning flag for each allergen in the product that exceeds the threshold amount corresponding to that allergen; and including the generated warning flags in the product information document.

The method may further comprise determining, by the one or more processors, for one or more of the identified allergens present in the product, one or more further exposure values, each further exposure value being indicative of an exposure of the user to that allergen during the time period. The safety assessment may be performed based on the determined one or more further exposure values. The one or more exposure values for an allergen may include a skin exposure value for that allergen, the skin exposure value for an allergen being indicative of an amount of that allergen per unit of area of the user’s skin that is exposed to that allergen within the time period. The skin exposure value for an allergen may be determined using a dermal absorption value of the skin of the user. The product information file may include at least one determined skin exposure value for an allergen.

The safety assessment may comprise: acquiring, by the one or more processors, for one or more of the identified allergens present in the product, a threshold for the skin exposure value for that allergen; and comparing, by the one or more processors, for one or more of the identified allergens present in the product, the skin exposure value for that allergen to the acquired skin exposure value threshold for that allergen. The safety assessment may comprise assigning, by the one or more processors, to one or more of the identified allergens present in the product, a safety label depending on the comparison of the skin exposure value for that allergen to the acquired skin exposure value threshold for that allergen. A fifth safety label may be assigned to an allergen present in the product if the skin exposure value for that allergen is greater than or equal to the acquired skin exposure value threshold for that allergen. A sixth safety label may be assigned to an allergen present in the product if the skin exposure value for that allergen is less than the acquired skin exposure value threshold for that allergen. The fifth safety label may indicate an unsafe ingredient. The sixth safety label may indicate a safe ingredient.

The method may further comprise acquiring, by the one or more processors, regulatory information for one or more of the ingredients in the product ingredient list. The safety assessment may be based on the acquired regulatory information.

At least one threshold from a set of thresholds may be dependent on the regulatory information, the set of thresholds consisting of: an MOS threshold, a safety value threshold for an ingredient, a safety value threshold for an allergen, and an allergen threshold amount. The method may further comprise: displaying, by a display operatively coupled to the one or more processors, a plurality of different jurisdictions; and receiving, by the one or more processors, a selection of a jurisdiction from the plurality of different jurisdictions. Acquiring the regulatory information may be based on the selected jurisdiction. The product information document may be generated in a format based on the selected jurisdiction.

The method may further comprise receiving, by the one or more processors, from an operator interface operatively coupled to the one or more processors, the product ingredient list.

The method may further comprise displaying, on a display operatively coupled to the one or more processors, the generated product information document.

The method may further comprise reformulating the product based on the generated product information document.

In a further aspect, the present invention provides apparatus for generating a product information document for a product. The apparatus comprises one or more processors configured to: acquire a product ingredient list for the product; acquire, for one or more ingredients in the ingredient list, a value of an amount of that ingredient used by a user of the product in a time period; acquire, for one or more physical properties of the user, a value of that physical property of the user; determine, for one or more ingredients in the ingredient list, using the value of the amount of that ingredient used by a user of the product in the time period and the one or more physical property values, one or more exposure values, each exposure value being indicative of an exposure of the user to that ingredient during the time period; perform a safety assessment based on the determined one or more exposure values; and generate a product information file including the results of the safety assessment.

In a further aspect, the present invention provides a computer program stored in a computer readable storage medium that, upon execution by a processor, cause the processor to: acquire a product ingredient list for a product; acquire, for one or more ingredients in the ingredient list, a value of an amount of that ingredient used by a user of the product in a time period; acquire, for one or more physical properties of the user, a value of that physical property of the user; determine, for one or more ingredients in the ingredient list, using the value of an amount of that ingredient used by a user of the product in the time period and the one or more physical property values, one or more exposure values, each exposure value being indicative of an exposure of the user to that ingredient during the time period; perform a safety assessment based on the determined one or more exposure values; and generate a product information file including the results of the safety assessment.

In a further aspect, the present invention provides a program or plurality of programs arranged such that when executed by a computer system or one or more processors it/they cause the computer system or the one or more processors to operate in accordance with the method of any of the above aspects.

In a further aspect, the present invention provides a machine readable storage medium storing a program or at least one of the plurality of programs according to the preceding aspect.

In a further aspect, the present invention provides a product information document for a product generated using a method according to any of the preceding aspects.

BRIEF DESCRIPTION OF THE DRAWINGS

Figure 1 is a schematic illustration (not to scale) showing a product, a system for assessing the product, and an operator of the system; and

Figure 2 is a process flow chart showing certain steps of an embodiment of a method of assessing the product.

DETAILED DESCRIPTION

Figure 1 is a schematic illustration (not to scale) showing a product 100, an embodiment of a system 102 for assessing the product 100, and an operator 104 of the system 102.

In this embodiment, the product 100 to be assessed is a personal hygiene product, for example, shampoo, body wash, wet wipes, or deodorant. However, in other embodiments, the product may be a different type of goods or product. Examples of other appropriate types of goods or products include, but are not limited to, pharmaceutical goods such as medicines, medical devices, toiletries products such as cosmetics products, and foodstuffs, toys, biocides, detergents, art materials, household products and industrial chemicals.

The system 102 comprises an operator interface 106, a product assessment module 108, a first database 110, a second database 112, a third database 114, and a fourth database 116.

The operator interface 106 is configured to receive an input from the operator 104. The operator interface 106 is coupled to the product assessment module 108 such that the operator interface 106 may send information input by the operator 104 to the product assessment module 106, and such that the operator interface 106 may receive information from the product assessment module 108. The operator interface 106 is configured to display, to the operator 104, information received by the operator interface 106 from the product assessment module 108. The operator interface 106 may include, for example, a touchscreen display, a monitor display, a keyboard, a mouse, an audio speaker, a voice recognition module, and/or a graphical user interface (GUI).

The product assessment module 108 is configured to process product-related information received from the operator interface 106 and input by the operator 104 to generate a product assessment report for the product 100. Processing performed by the product assessment module 108 is described in more detail later below with reference to Figure 2. The product assessment module 108 is further configured to send the generated product assessment report to the operator interface 106 for display to the operator 104.

In addition to being coupled to the operator interface 106, the product assessment module 108 is coupled to each of the first database 110, the second database 112, the third database 114, and the fourth database 116 such that information may be sent between the product assessment module 108 and each of the databases 110-116. In this embodiment, as described in more detail later below with reference to Figure 2, the product assessment module 108 may retrieve information from one or more of the databases 110-116, for example, for use in generating the product assessment report. Also, the product assessment module 108 may send information to one or more of the databases 110-116, for example, to modify information stored in one or more of the databases 110-116. For example, using a received user input, the product assessment module 108 may update, replace, delete, and/or modify one or more data items stored in one or more of the databases 110-116.

In this embodiment, the first database 110 comprises information related to a plurality of different types of products. The information within the first database 110 is arranged hierarchically into categories or groups. Each of the group may contain sub-groups, which may themselves contain further subgroups, and so on.

The terminology “group of products” or “product group” is understood herein to refer any appropriate group or class of products that have the same or similar properties. A product group may include one or more subgroups of products, which are hereinafter referred to as “product types”. For example, a product group in the first database 110 may be a “personal hygiene” group of products and a “cosmetics group” of products. The “personal hygiene” product group may include “product types” (i.e. subgroups) including but not limited to “shampoo type products”, “body wash type products”, “wet wipe type products”, and “deodorant type products”.

In this embodiment, the first database 110 comprises, for each of the different products types, the following information: - A label for that product type, for example, “shampoo type products” or “wet wipe type products”. - An amount of that product type that is used in a typical single use. For example, for the “shampoo type products”, a typical single use amount may be 4g. Also for example, the “wet wipe type products”, a typical single use amount may be a single wet wipe containing 3g of liquid. - A number of times that product type is typically used in a given time period (e.g. per day). For example, typically “shampoo type products” may be used once per day by a user. Also for example, the “wet wipe type products” may be used on average 20 times per day by a user. - A list of the parts of a human body that are exposed to that product type during a typical use, i.e. parts of the human body that are foreseeably exposed to that type of product during use. For example, for the “shampoo type products”, the hands, face, hair, etc. of an adult may be listed. Also for example, for the “wet wipe type products”, the hand of an adult may be listed, as well as various parts of a baby’s body. - A duration that the user is exposed to that product type during a typical use. Such a duration may be specified for each of the parts of a human body that are exposed to that type of product during a typical use. For example, for the “shampoo type products”, an exposure duration of 3 minutes may be specified for the hair of the user. Also for example, for the “wet wipe type products”, a relatively long exposure duration may be specified to represent a residual layer of liquid being left in contact with the hands of the user. - A retention factor for that product type. A retention factor may specify a proportion of the applied product that is retained by a user after use. A retention factor may, for example, be expressed as a percentage of an applied amount. For example, for the “shampoo type products”, a retention factor of 1% may be specified for the hair of the user. Also for example, for the “wet wipe type products”, a retention factor of 10% may be specified for the hands of the adult user. In this embodiment, the retention factor for a product is that same value for each part of the human body exposed to that product during a typical use. Flowever, in other embodiments, different retention factors may be specified for different body parts. - A dilution level for that product type in use. A dilution level for a product type may specify a degree to which that product type is diluted in use. Dilution levels may be specified for each of the parts of a human body that are exposed to that product type during a typical use. For example, for the “shampoo type products”, in use the shampoo type product may be applied neat (i.e. dilution of 0) to the hair and hands of the user, but may be diluted to at least some extent (e.g. a dilution factor of 1 in 25) for other areas of the user’s body.

In other embodiments, the first database 110 comprises different product related information instead of or in addition to that described above.

In this embodiment, the information stored within the first database 110 is arranged or grouped into, for each type of product, one or more “exposure scenarios”, which are indicated in Figure 1 by boxes and the reference numerals 118. An exposure scenario 118 for a product type may specify an example use of that product type by a user. An exposure scenario 118 for a product type may specify, for example, one or more of the following: an amount of that type of product that is used, a number of times that type product is typically used in a given time period, a list of the parts of a human body that are exposed to the product type, durations that the various parts of the user are exposed to the product type, one or more retention factors for that type of product, and one or more dilution level for that type of product. Exposure scenarios 118 may include one or more different parameter values instead of or in addition to one or more of the parameter values listed previously.

The data contained within the first database 110 may have been acquired in any appropriate way. For example, some or all of the data within the first database 110 may have been acquired from product manufacturers, clinical trials, consumer studies, published scientific literature, or a combination thereof. In some embodiments, the operator 104 may have acquired data for inclusion in the first database 110, and then input that information into the first database 110 using the operator interface 106.

In this embodiment, the second database 112 comprises information related to a plurality of different types of potential product users. In particular, in this embodiment, the second data base 112 contains information related users including, but not limited to, a “human adult”, an “older human child”, a “younger human child”, and a “human baby”. In other embodiments, the second database 112 may contain information related to other types of product user or consumer instead of or in addition to those listed previously, for example, animal users.

The terminology “type of user” is understood herein to refer any appropriate group or class of users that have the same or similar properties, for example, the same or similar physical properties.

In this embodiment, the second database 112 comprises, for each of the different types of user, the following information: - A label for that type of user, e.g. “human adult”, “older human child”, “younger human child”, and “human baby”. - An age range for that type of user. For example, “human adult” users may be specified to be 16 years old or older, “older human child” users may be specified to be between 12 and 16 years old, “middle to late childhood” users may be specified to be between 6 and 12 years old, “early childhood” users may be specified to be between 3 and 6 years and “human infants” users may be specified to be between 0 and 3 years of age. - A typical weight or weight range for that type of user. - A list of the parts of the body of that type of user on which products may be used. For example, for each of the different types of user, the following body parts may be specified: scalp, face, arms, legs, etc. - For each of the listed parts of the body of that type of user, a typical surface area of on that part of the body. Older users tend to have larger body parts than younger users. For example, the surface areas of the body parts of the hands of a “human adult” user would tend to be larger than those of a “human baby” user.

In some embodiments, the second database 112 comprises further information instead of or in addition to that mentioned above, for example, for each of the different types of user and for each of the listed parts of the body of that type of user, a typical absorption rate of skin of that part of the body.

Younger users tend to have higher skin absorption rates than old users. For example, the absorption rates of the body parts of a “human baby” user would tend to be larger than those of a “human adult” user.

In some embodiments, one or more of the exposure scenarios 118 contained within the first database 110 is not applicable to all of the different types of user. For example, an exposure scenario 118 that specifies an example use of an adult body wash may not be applicable to “human baby” users. The second database 112 may comprise, for each of the different types of user, information that specifies which of the exposure scenarios 118 correspond to that type of user. Information specifying an assignment between the exposure scenarios 118 and the different types of users may be contained in the second database 112, or a different database.

In other embodiments, the second database 112 comprises different user related information instead of or in addition to that described above.

The data contained within the second database 112 may have been acquired in any appropriate way. For example, some or all of the data within the second database 112 may have been acquired from product manufacturers, clinical trials, consumer studies, published scientific literature, or a combination thereof. In some embodiments, the operator 104 may have acquired data for inclusion in the second database 112, and then input that information into the second database 112 using the operator interface 106.

In this embodiment, the third database 114 comprises information related to a plurality of different potential product ingredients. Ingredients include, but are not limited to, chemicals, mixtures of chemicals, materials, biological extracts or mineral extracts.

In this embodiment, the third database 114 comprises, for each of the different ingredients, the following information: - A name of that ingredient or other label/identifier. Synonyms for each ingredient may also be included. - One or more physical properties of that ingredient, which may include, for example, a boiling point, a viscosity, a colour, a solubility, etc. - Toxicology data for that ingredient. Toxicology data may include, but is not limited to, a no observed adverse effect level (NOAEL) and/or another type of “safe use” level. Further information on NOAELs is provided later below. - A threshold level for a Margin of Safety (MOS) for that ingredient. Further information about thresholds levels for MOS values is provided in more detail later below with reference to Figure 2. - Regulatory information relating to that ingredient. Regulatory information for an ingredient may specify one or more rules or criteria that are to be satisfied if that ingredient is present in a product. Further information on regulatory information that may be used in this embodiment is provided later below. - A percentage dermal absorption for that ingredient, i.e. for each ingredient, the percentage of that ingredient that is absorbed into a user’s body through their skin when that product is applied to the user’s skin. A NOAEL may be defined to be an exposure level at which there is no statistically or biologically significant increases in the frequency or severity of adverse effects between the exposed population and its appropriate control.

Preferably, NOAEL data is acquired from test or studies performed on humans (i.e. the “specifies of interest” in this embodiment). However, in some embodiments, NOAEL data may be acquired from testing on a different species, e.g. animal testing. Preferably, the third database 114 includes NOAEL data for each of the different types of user.

Preferably, the third database 114 includes both “systemic” (or “global”) and “local” NOAELs for each ingredient. A systemic NOAEL may be understood to be a NOAEL for a whole organism. Thus, systemic NOAELs relate to systemically mediated adverse effects of ingredients. A “local” NOAEL may be understood to be a NOAEL for only a part, typically external part such as the skin or eye, of an organism, i.e. not the whole organism. Thus, local NOAELs relate to locally mediated adverse effects of ingredients. An example, local NOAEL is a NOAEL related to skin or eye irritation. Local NOAELs for ingredients may be acquired, for example, from patch tests performed on human or animal subjects.

In this embodiment, a local NOAEL is a NOAEL in respect of locally mediated effects (such as irritancy). In this embodiment, the regulatory information for an ingredient is arranged or grouped in to a plurality “regulatory regimes”, which are represented in Figure 1 by boxes and indicated by the reference numerals 120. Each regulatory regime 120 corresponds to a respective product ingredient. Also, each regulatory regime 120 corresponds to a respective regulatory body (e.g. the government of a country). Thus, each regulatory regime 120 specifies the rules and regulations relating to a respective product ingredient imposed by a respective regulatory body. For example, different regulatory bodies may have different regulations for a given product ingredient.

Regulatory information for an ingredient may be specified for each of a plurality of different product types. For example, the regulations (for a given country or jurisdiction) for a given ingredient when used in one type of product may be different to the regulations for the same ingredient when used in a different type of product.

Regulatory information for a given ingredient may be set, for example, by a government body or other organisation.

In other embodiments, the third database 114 comprises different ingredient related information instead of or in addition to that described above.

The data contained within the third database 114 may have been acquired in any appropriate way. For example, some or all of the data within the third database 114 may have been acquired from government bodies, industry organisation, standards agencies, laboratory testing, etc. In some embodiments, the operator 104 may have acquired data for inclusion in the third database 114, and then input that information into the third database 114 using the operator interface 106.

In this embodiment, the fourth database 116 comprises information related to a plurality of different allergens that may be present in a product. Allergens include, but are not limited to, individual chemicals. One or more of the allergens specified in the fourth database 116 may be same as one or more of the ingredients specified in the third database 114.

In this embodiment, the fourth database 116 comprises, for each of the different allergens, the following information: - A name of that allergen. Synonyms for each allergen may also be included. - A specification of “safe” and/or “unsafe” levels (i.e. a safety level) of that allergen in a product. The safe and unsafe levels may be expressed in any appropriate way, and in any appropriate units. For example, for an allergen that is found in products that are applied to a user’s skin (e.g. a face cream), an unsafe level for that allergen may be an amount of that allergen that is absorbed into the user’s skin expressed in, for example, mg/cm2 or mg/cm2/day.

In other embodiments, the fourth database 116 comprises different allergen related information instead of or in addition to that described above.

The data contained within the fourth database 116 may have been acquired in any appropriate way. For example, some or all of the data within the fourth database 116 may have been acquired from government bodies, industry organisations, standards agencies, product manufacturers, clinical trials, published scientific data, laboratory testing, etc. In some embodiments, the operator 104 may have acquired data for inclusion in the fourth database 116, and then input that information into the fourth database 116 using the operator interface 106.

Apparatus, including the product assessment module 108, for implementing the above arrangement, and performing the method steps to be described later below, may be provided by configuring or adapting any suitable apparatus, for example one or more computers or other processing apparatus or processors, and/or providing additional modules. The apparatus may comprise a computer, a network of computers, or one or more processors, for implementing instructions and using data, including instructions and data in the form of a computer program or plurality of computer programs stored in or on a machine readable storage medium such as computer memory, a computer disk, ROM, PROM etc., or any combination of these or other storage media.

One or more content servers may, for example, comprise the databases 110-116.

Figure 2 is a process flow chart showing certain steps of an embodiment of a method of assessing the product 100.

At step s2, using the operator interface 106, the operator 104 inputs an identifier for the product 100 to the product assessment module 108. The identifier for the product 100 may include, for example, a name of the product 100 and a reference number for the product 100.

In some embodiments, other, different product specific information may be input by the operator 104 instead of or in addition to the identifier.

At step s4, using the operator interface 106, the operator 104 selects a product type for the product 100.

In this embodiment, the product type for the product 100 is selected from the different product types stored in the first database 110. For example, a list of all the different product groups may be displayed on the operator interface 106 by the product assessment module 108. The operator 104 may then select a product group corresponding to the product 100 from the selected list. A list of all the different product types within the selected product group may be displayed on the operator interface 106 by the product assessment module 108. The operator 104 may then select a product type corresponding to the product 100 from currently displayed list. For example, if the product 100 is a bottle of shampoo, the operator 104 may first select the “personal hygiene” product group, and then select the “shampoo type product” entry.

In some embodiments, the operator 104 may select multiple different product types for the product 100, for example, if the product 100 can be used as multiple different types of product.

At step s5, using the operator interface 106, the operator 104 selects a regulatory regime 120 for the product 100.

In this embodiment, the regulatory regime 120 for the product 100 is selected from the different regulatory regimes 120 stored in the third database 116. For example, a list of all the different regulatory regimes 120 may be displayed on the operator interface 106 by the product assessment module 108. The operator 104 may then select, from the displayed list, a regulatory regime 120 they want the product to be assessed with respect to.

In some embodiments, the operator 104 may select multiple different regulatory regimes 120 for the product 100, for example, if the product 100 is to be sold in multiple different jurisdictions.

In this embodiment, the product assessment module 108 adheres to the selected regulatory regime 120 during the performance of the remaining steps of the process of Figure 2.

At step s6, using the operator interface 106, the operator 104 selects a type of user for the product 100.

In this embodiment, the user type for the product 100 is selected from the different user types stored in the second database 112. For example, a list of all the different types of user may be displayed on the operator interface 106 by the product assessment module 108. The operator 104 may then select a user type corresponding to the product from the selected list. For example, if the product 100 is intended for use by a human adult, the operator 104 selects the “human adult” user type from the displayed list.

In some embodiments, the operator 104 may select multiple different user types for the product 100, for example, if multiple the product 100 can be used by multiple different types of user.

At step s8, using the selected product type and the selected user type, the product assessment module 108 automatically selects an exposure scenario 118 for the product 100.

In this embodiment, the exposure scenario 118 for the product 100 selected from the stored different exposure scenarios 118 corresponds to the selected product type and the selected user type.

In some embodiments, for example in embodiments where there are multiple different exposure scenarios for the selected “product type” and “user type” combination, the exposure scenario 118 is not selected automatically by the product assessment module 108, and is instead selected manually by the operator 104 using the interface 106. In some embodiments, the product assessment module 108 filters the exposure scenarios 118 to identify those exposure scenarios 118 that correspond to the selected product type and user type. The identified exposure scenarios 188 are then displayed to the operator 104, e.g., as a list, using the operator interface 106. The operator 104 may then select one or more exposure scenarios 118 from those displayed.

In some embodiments, the operator 104 may select multiple different exposure scenarios 118. One or more exposure scenarios 118 may be selected for each of the different selected user types.

At step s10, the product assessment module 108 calculates a systemic exposure dose (SED) for the selected user type and for the product 100.

In this embodiment, the SED is calculated using the selected exposure scenario 118, and the information relating to the selected user type stored in the second database 112.

In this embodiment, the SED is calculated as follows.

The product assessment module 108 determines the selected user’s exposure to the product 100. This exposure may be expressed in terms of an amount of the product 100 used by the user in a given time period per unit of mass of the selected user. For example, the user’s exposure may be expressed in terms of milligrams of product per kilogram of mass of the user per day, i.e. in mg/kg/day. In this embodiment the dermal absorption of a user is assumed to be 100% to represent a “worst” case. Thus, the user’s exposure to the product 100 calculated by the product assessment module 108 is the SED. For example, if the user’s exposure to the product 100 is 150mg/kg/day then the SED for the product 100 is 150mg/kg/day.

In some embodiments, the product assessment module 108 calculates multiple different SEDs for the product 100, for example, where multiple different user types and/or exposure scenarios 118 have been selected.

In some embodiments, the SED is calculated in a different appropriate way, for example, as specified in the selected regulatory regime 120.

At step s12, the product assessment module 108 calculates a so-called “skin exposure value” for the selected user type and for the product 100.

In this embodiment, the skin exposure value is calculated using the selected exposure scenario 118, and the information relating to the selected user type stored in the second database 112.

In this embodiment, the skin exposure value is an amount of the product 100 used by the user in a given time period per unit of surface area of the user’s skin to which the product is applied. For example, the skin exposure value may be expressed in terms of milligrams of product per square centimetre of the user’s skin to which the product is applied per day, i.e. in mg/cm2/day.

In some embodiments, the product assessment module 108 calculates multiple different skin exposure values for the product 100, for example, where multiple different user types and/or exposure scenarios 118 have been selected.

In some embodiments, the skin exposure value takes into account the retention factor of the product, which specifies how much of the product stays in contact with the user’s skin after use. In some embodiments, calculation of the skin exposure value assumes that a user’s dermal absorption is 100%, and that 100% of the retained product is absorbed by the user. However, in some embodiments, the user’s actual dermal absorption, which may be less than 100% (and may be stored in the third database 114) is used to calculate the skin exposure value.

In some embodiments, the skin exposure value is calculated in a different appropriate way, for example, as specified in the selected regulatory regime 120.

At step s14, using the operator interface 106, the operator 104 inputs the formulation of the product 100 to the product assessment module 108. In other words, the operator 104 inputs a list of ingredients that make up the product 100. In this embodiment, the operator 104 also inputs the relative proportions of the ingredients of the product 100.

At step s16, the product assessment module 108 calculates a SED for each ingredient of the product 100.

In this embodiment, the SED for an ingredient is calculated using the SED of the product 100 (determined at step s10) the proportion of that ingredient in the product 100, and the dermal absorption of the user for that ingredient. In particular, the SED for an ingredient is calculated by multiplying the SED of the product 100, the proportion of that ingredient in the product 100, and the dermal absorption of the user (as stored in the third database 114).

For example, if the SED for the product 100 is 150mg/kg/day, the proportion of ingredient X in the product 100 is 5%, and the user’s dermal absorption of ingredient X is 50%, then the SED for ingredient X is 150mg/kg/day x 0.05 x 0.5 = 3.75mg/kg/day.

In some embodiments, the SED for an ingredient is calculated in a different appropriate way.

At step s18, the product assessment module 108 calculates a skin exposure value for each ingredient of the product.

In this embodiment, the skin exposure value for an ingredient is calculated using the skin exposure value of the product (determined at step s12), the proportion of that ingredient in the product, and the user’s dermal absorption of the ingredient. In particular, the skin exposure value for an ingredient is calculated by multiplying the skin exposure value of the product 100 by the proportion of that ingredient in the product. The skin exposure value for an ingredient may be expressed in any appropriate terms, for example, mg/cm2/day.

In some embodiments, the skin exposure value for an ingredient is calculated in a different appropriate way.

At step s20, the product assessment module 108 retrieves, from the third database 114, systemic NOAELs for each of the ingredients of the product 100.

In some embodiments, one or more of the retrieved systemic NOAELs is dependent upon the regulatory regime 120 selected at step s5. For example, in some embodiments, only those systemic NOAELs that correspond to the selected regulatory regime 120 are retrieved.

Preferably, systemic NOAELs corresponding to the selected user type are retrieved.

At step s22, the product assessment module 108 retrieves, from the third database 114, local NOAELs for each of the ingredients of the product 100.

In some embodiments, one or more of the retrieved local NOAELs is dependent upon the regulatory regime 120 selected at step s5. For example, in some embodiments, only those local NOAELs that correspond to the selected regulatory regime 120 are retrieved.

Preferably, local NOAELs corresponding to the selected user type are retrieved.

In some embodiments, at steps s20 and s22, the product assessment module 108 acquires, e.g. from the third database 114, different toxicology data relating to the ingredients of the product 100 instead of or in addition to systemic and local NOAELs for each of the ingredients of the product 100. For example, the product assessment module 108 may retrieve, from the third database 114, different “safe use” levels for one or more of the ingredients of the product 100.

At step s24, the product assessment module 108 calculates the Margin of Safety (MOS) for each ingredient.

In this embodiment, the MOS is defined to be the systemic NOAEL for that ingredient (acquired at step s20) divided by the SED for that ingredient (determined at step s16), i.e.:

For example, if the SED for ingredient X is 3.75mg/kg/day, and the systemic NOAEL for ingredient X is 500mg/kg/day, then the MOS for ingredient X is 500/3.75 = 133.33.

At step s26, the product assessment module 108 calculates a so-called Local Safety Factor (LSF) for each ingredient.

In this embodiment, the LSF is defined to be the local NOAEL for that ingredient (acquired at step s22) divided by the skin exposure value for that ingredient (determined at step s18), i.e.:

At step s28, the product assessment module 108 retrieves, from the third database 114, safety level threshold values for each ingredient of the product.

In this embodiment, the safety level thresholds acquired by the product assessment module 108 are those that correspond to the selected regulatory regime 120.

In this embodiment, the product assessment module 108 acquires, for each ingredient of the product, a threshold value for the computed MOS for that ingredient. Also, in this embodiment, the product assessment module 108 acquires, for each ingredient of the product, a threshold value for the computed LSF for that ingredient.

Threshold levels for a MOS values and LSF values may, for example, be specified in the regulatory information relating to that ingredient that is stored in the third database 114. Such threshold values may have been specified by a regulatory body, or may be determined via experimentation. In some embodiments, one or more of the threshold values is dependent upon the regulatory regime 120 selected at step s5.

In some embodiments, for one or more of the ingredients, an MOS threshold value of 100 is used. Such a threshold value may be used, for example, where the systemic NOAEL has been calculated from animal testing. Such a threshold value advantageously tends to account for interspecies variability and intraspecies (i.e. interhuman) variability. For example, an MOS threshold value of 100 may result from the use of an interspecies variability factor of 10 (to account for differences between test animals and humans) and an intraspecies variability factor of 10 (to account for difference between humans). In other embodiments, different (e.g. lower) values may be used for the interspecies variability factor and the intraspecies variability factor.

In some embodiments, a different MOS threshold value (i.e. other than 100) is used for one or more of the ingredients. For example, for one or more of the ingredients, an MOS threshold value of less than 100 is used.

In some embodiments, for example embodiments in which the systemic NOAEL for an ingredient has been calculated from testing on the species of interest (e.g. humans), use of the interspecies variability factor can be avoided. Also, in some embodiments, use of the intraspecies variability factor can be avoided. Thus, an MOS threshold value in the range 1 to 10 may be used.

For example, if a relatively small-scale study involving testing on a relatively small sample of the human population was used to test ingredient X, then the interspecies variability factor may be omitted, and an intraspecies variability factor of 10 would yield an MOS threshold value of 10. Similarly, if an extensive, relatively large-scale study involving testing on a relatively large sample of the human population was performed to test ingredient X, then the both interspecies variability factor may be omitted, and an MOS threshold value of 1 would be used.

Preferably, where available, NOAELs based on testing on the species of interest are used, thereby allowing for use of the lowest possible MOS/LSF threshold values.

In some embodiments, the product assessment module 108 computes, for one or more of the ingredients, a threshold value for the computed MOS for that ingredient. Such computation may be performed based on available interspecies and/or intraspecies variability factor for that ingredient.

At step s30, for each ingredient, the product assessment module 108 compares the computed MOS for that ingredient to the corresponding MOS threshold value. Also, for each ingredient, the product assessment module 108 compares the computed LSF for that ingredient to the corresponding LSF threshold value.

At step s32, based on the comparisons performed at step s30, the product assessment module 108 assigns, to each of the ingredients of the product 100, a safety label.

In this embodiment, if the computed MOS for an ingredient is less than or equal to the corresponding MOS threshold for that ingredient, the product assessment module 108 assigns an “unsafe” label to that ingredient.

Also, if the computed MOS for an ingredient is greater than the corresponding MOS threshold for that ingredient, the product assessment module 108 assigns a “safe” label to that ingredient.

Also, if the computed LSF for an ingredient is less than or equal to the corresponding LSF threshold for that ingredient, the product assessment module 108 assigns an “unsafe” label to that ingredient.

Also, if the computed LSF for an ingredient is greater than the corresponding LSF threshold for that ingredient, the product assessment module 108 assigns a “safe” label to that ingredient.

At step s34, the product assessment module 108 analyses the formulation of the product 100 supplied by the operator 104 at step s14 to identify all allergens present in the product 100.

In this embodiment, the product assessment module 108 uses information stored in the fourth database 116 to identify allergens in the product 100. For example, the product assessment module 108 may compare the ingredients of the product 100 to a list of allergens stored in the fourth database 116.

At step s38, the product assessment module 108 calculates the total amount of each of the identified allergens in the product 100. The product assessment module 108 also calculates, for each of the identified allergens, the total proportion of that allergen in the product 100.

In this embodiment, the amounts and proportions of the allergens in the product 100 are determined using the product formation supplied by the operator 104 at step s14. A common allergen may be present in multiple different ingredients of a product 100. In such cases, the product assessment module 108 may sum the amounts of the common allergen over those ingredients.

At step s40, for each identified allergen, the product assessment module 108 compares product labelling requirements specified in the selected regulatory regime 120 to the computed total amount of that allergen in the product 100.

At step s42, based on the comparison performed at step s42, the product assessment module 108 assigns a flag to each identified allergen.

In this embodiment, if the total amount of an allergen in the product 100 is less than less than the corresponding threshold for labelling that allergen set by the selected regulatory regime 120, the product assessment module 108 assigns a label to that allergen that indicates that the allergen is present but labelling of that allergen on the packaging for the product 100 is not required by the relevant regulatory regime 120. In some embodiments, the product assessment module 108 does not assign a label the allergens that have total amounts/proportions less than the corresponding threshold.

Also, if the total amount of an allergen in the product 100 is greater than or equal to the corresponding threshold for labelling that allergen set by the selected regulatory regime 120, the product assessment module 108 assigns a label to that allergen that indicates that the allergen is present and is required, by the relevant regulatory regime 120, to be labelled on the packaging for the product 100.

At step s44, the product assessment module 108 calculates a skin exposure value for each allergen in the product 100.

In this embodiment, the skin exposure value for an allergen is calculated using the skin exposure value of the product (determined at step s12) and the proportion of that allergen in the product (determined at step s38). In particular, the skin exposure value for an allergen is calculated by multiplying the skin exposure value of the product 100 by the proportion of that allergen in the product. The skin exposure value for an allergen may be expressed in any appropriate terms, for example, mg/cm2/day.

In some embodiments, the skin exposure value for an allergen is calculated in a different appropriate way.

At step s46, for each allergen in the product 100, the product assessment module 108 retrieves, from the fourth database 116, a threshold “safe/unsafe” level (i.e. a safety level) of that allergen in the product 100.

The safety levels acquired by the product assessment module 108 may be those that correspond to the selected regulatory regime 120. A threshold “safe/unsafe” level may, for example, be a local NOAEL value for an allergen, which may be expressed, for example in mg/cm2/day. In some embodiments, LSF values for one or more of the allergens may be determined based on a skin exposure value and a local NOAEL for that allergen.

At step s48, for each allergen in the product 100, the product assessment module 108 compares the computed skin exposure value for that allergen to the corresponding threshold “safe/unsafe” level for that allergen.

At step s50, based on the comparisons performed at step s48, the product assessment module 108 assigns, to each of the allergen in the product 100, a safety label.

In this embodiment, if the computed skin exposure value for an allergen is less than the corresponding threshold “safe/unsafe” level for that allergen, the product assessment module 108 assigns a “safe” label to that allergen.

Also, if the computed skin exposure value for an allergen is greater than or equal to the corresponding threshold “safe/unsafe” level for that allergen, the product assessment module 108 assigns an “unsafe” label to that allergen.

At step s52, the product assessment module 108 generates an assessment report for the product 100. Herein, the terms “assessment report”, “output document”, and “product information document” are used interchangeably.

In this embodiments, the assessment report includes results of the calculations performed by the product assessment module 108 during steps s2 to s50. In this embodiment, the assessment report for the product 100 includes at least the following information: - The product identifier(s) (provided by the operator 104 at step s2). - An indication of the selected product type(s) (specified by the operator at step s4). - An indication of the selected regulatory regime(s) 120 (specified by the operator at step s5). - An indication of the product user(s) (specified by the operator at step s6). - The SED(s) for the product 100 (determined at step s10). - The skin exposure value(s) for the product 100 (determined at step s12). - A list of the product ingredients (specified by the operator at step s14). - The SEDs, MOSs, skin exposure values, and/or LSFs for one or more of the ingredients. The corresponding safety labels assigned to the product ingredients (assigned at step s32) may also optionally be included. - A list of the product allergens (determined at step s34). - The corresponding flags assigned to the product allergens (assigned at step s42). - The skin exposure values for one or more of the ingredients. The corresponding safety labels assigned to the product allergens (assigned at step s50) may also optionally be included.

In some embodiments, other data is included in an assessment report instead of or in addition to one or more of the information items listed above. Examples of other information that may be included in an assessment report includes, but is not limited to: - physical and/or chemical characteristics of the finished product, which may be entered by the user into the assessment module using the user interface; - instructions for use, which may be specified by a manufacturer or distributer and entered into the assessment module using the user interface; - a warning/precaution, which may be determined automatically by the system based on the presence of a substance and/or its MOS, or may be determined by expert review and manually entered into the assessment module using the user interface; - an exposure scenario, which may be based on the product type and user group; - conclusions of an expert on the safety of the product, which may be entered into the assessment module using the user interface; - toxicological profiles and/or regulatory data on individual chemicals, chemical mixtures, etc. present in the product; and - toxicological profiles and/or regulatory data on individual allergens present in the product.

In some embodiments, an assessment report includes different information instead of or in addition to one or more of the information items listed above. For example, in some embodiments, the product assessment module 108 verifies or otherwise the product 100. For example, if the assessment report for the product 100 includes one or more “unsafe” labels, the product assessment module 108 may state on the assessment report that the product 100 is “not approved”. Also, if the assessment report for the product 100 does not include any “unsafe” labels, the product assessment module 108 may state on the assessment report that the product 100 is “approved”.

In some embodiments, one or more of the above information items may be omitted from the assessment report.

In some embodiments, the product assessment module 108 acquires, for example from a memory or one of the databases 110-116, a template for the assessment report. The product assessment module 108 may then populate the template with the data calculated for the product 100 to produce the assessment report.

In some embodiments, the product assessment module 108 selects a template with which to generate the assessment report from a plurality of different templates. This selected may be based on the selected regulatory regime 120, for example, if different jurisdictions different formatting for products assessment reports.

At step s54, the product assessment module 108 displays, using the operator interface 106, for use by the operator 104, the assessment report.

The operator 104 may act on or utilise the assessment report in any appropriate way.

For example, in some embodiments, the operator 104 approves or otherwise the product 100 for sale in the jurisdiction corresponding to the selected regulatory regime 120. In some embodiments, approval or otherwise of the product 100 may be performed by the product assessment module 108. In some embodiments, the product 100 is approved if no “unsafe” safety labels have been generated for that product 100, i.e. all of the ingredients and allergens listed in the assessment report have been assigned a “safe” safety label.

Also for example, the operator 104 may refer the product 100 for expert review. For example, in the case where one or more “unsafe” safety labels have been assigned to constituents of the product 100, the product 100 and assessment report may be reviewed by a product safety expert.

In some embodiments, the assessment report is used to change the formulation of the product. For example, based on the assessment report, quantities of one or more of the ingredients in the product 100 may be changed so as to remove, negate, or render moot the “unsafe” safety labels and allow for approval of the product 100.

Thus, a method of assessing the product 100 is provided.

Advantageously, the above described system and method tends to provide a product assessment that considers both systemic (i.e. whole body) and local effects of the product on users of the product. The present inventors have realised that not all adverse effects of products are mediated systemically. The present inventors have realised that some adverse effects of products are mediated locally, for example on regions of the user’s skin on which a product is applied. By only using “systemic” NOAELs to assess a product, local adverse effects tend to be missed in the product assessment. Advantageously, the use of “local” NOAELs to assess local effects of product ingredients tends to allow for the product to be assessed with respect to its local effects on the user, and tends to allow for adverse effects of ingredients mediated locally on a user’s body (e.g. per unit area of skin) to be considered.

The above described system and method allows for assessment reports of product to be generated in an efficient and consistent manner. Furthermore, the above described system tends to allow for efficient and convenient storage and manipulation of data.

The above described system and method is advantageously useable for multiple different types of product across different industries.

The above described system and method tends to synergistically combine information from different information sources including, but not limited to, manufacturers data, regulatory data, scientific journals, testing and experimental data. The data may be combined to provide an advantageously thorough and comprehensive assessment of a product.

The above described system is advantageously modular. Thus, for example, certain data or processing modules may be updated, added to, or removed from the system easily. Thus, the system may easily be adapted to changes in regulation, or new experimental data becoming available.

Also, advantageously, the specifications of a user type and/or a usage scenario may be modified to allow a user to tailor the assessment of the product to the specific product, its user and how the user will use the specific product. Thus, the product assessment tends to be performed on the actual product as opposed to, for example, a standardised version of the product.

The above described system and method advantageously tends to be capable of assessing the product with respect to multiple different users and multiple different usage scenarios. Thus, a comprehensive assessment of the product tends to be provided. Also, the users/user types and usage scenarios with respect to which the product is assessed are selectable by a user, or a processor such as the product assessment module. This tends to provide that the assessment performed on the product is appropriate for that product.

Advantageously, the safety labels and other flags (and also other parameters values such as SED values) that are assigned to the product tend to be calculated based on how the product is foreseeable or actually used by users.

The above described system and method advantageously provides reliable product screening that tends to eliminate or reduce the possibility of an adverse effect on a user using a product or device. Thus, users can trust that the product that has undergone the above described assessment is “safe”. Furthermore, the above described system and method advantageously tends to ensure that the product includes adequate warning of potential adverse effects of using the product.

Advantageously, product manufacturers may be provided with warnings for product ingredients that may be restricted or prohibited in certain jurisdictions. This early warning tends to provide manufacturers with an opportunity to reformulate their product, for example, in order to streamline the product approval process in as many jurisdictions as possible, or in key jurisdictions.

It should be noted that certain of the process steps depicted in the flowchart of Figure 2 and described above may be omitted or such process steps may be performed in differing order to that presented above and shown in Figure 2. Furthermore, although all the process steps have, for convenience and ease of understanding, been depicted as discrete temporally-sequential steps, nevertheless some of the process steps may in fact be performed simultaneously or at least overlapping to some extent temporally.

In the above embodiments, a single product is assessed. However, in other embodiments, multiple different products may be assessed simultaneously. For example, in some embodiments, the system may include multiple different user interfaces that may be used simultaneously by multiple different users to generate assessment reports for multiple different products.

In the above embodiments, the system comprises four databases. However, in other embodiments, the system may include a different number of databases, for example, a single database that includes all data used by the product assessment module.

In the above embodiments, the safety labels are assigned to the ingredients and allergens of the product based on a comparison of MOS, LSF, and/or skin exposure values with relevant threshold values. The thresholds applied are dependent upon the selected regulatory regime with respect to which the product is to be assessed. However, in other embodiments, safety labels are assigned to one or more ingredients and/or allergens based on different criteria. For example, if the selected regulatory regime specifies that a particular ingredient is prohibited, an unsafe label may be assigned to that product if that ingredient appears in the list of ingredients specified by the operator. Also for example, if the selected regulatory regime specifies an amount above which that ingredient may not occur in a product, an unsafe label may be assigned to that product if the amount of that ingredient in the product exceeds the specified amount.

In the above embodiments, the safety labels assigned to the ingredients and allergens are binary and have values of “safe” and “unsafe”. However, in other embodiments, one or more of the safety labels are not binary. For example, a safety label may have more than two possible values (e.g. “red”, “amber”, “green”).

In the above embodiments, each allergen present in the product is assigned a safety label based on the local adverse effects of that allergen. However, in other embodiments one or more of the allergens is assigned a safety level based on the systemic adverse effects of that allergen instead of or in addition to safety label based on the local adverse effects of that allergen. Whether or not to assign safety labels to allergens based on local and/or systemic effects on the user may be specified in the selected regulatory regime.

In the above embodiments, the product assessment report is generated as described above. However, in other embodiments, different data is used to generate the assessment report instead of or in addition to that described above. For example, in some embodiments, data relating to the history of use of an ingredient may be used to assess the product. Such history of use data may, for example, specify levels of an ingredient present in products already released to market, for example, products that have previously been approved with respect to one or more regulatory regimes.

The above described methods of generating a product information document for a product may also be considered to be methods of providing or generating or specifying product safety assessment information for a product, and/or methods of performing a safety assessment on a product, and/or methods of generating or determining a product information file or report for a product, and/or methods of generating or determining a safety specification for a product.

Claims

1. A method for generating a product information document for a product, the method comprising: acquiring, by one or more processors, a product ingredient list for the product; acquiring, by the one or more processors, for one or more ingredients in the ingredient list, a value of an amount of that ingredient used by a user of the product in a time period; acquiring, by the one or more processors, for one or more physical properties of the user, a value of that physical property of the user; for the one or more ingredients in the ingredient list, using the value of the amount of that ingredient used by a user of the product in the time period and the one or more physical property values, determining, by the one or more processors, one or more exposure values, each exposure value being indicative of an exposure of the user to that ingredient during the time period; performing, by the one or more processors, a safety assessment based on the determined one or more exposure values; and generating, by the one or more processors, a product information file including the results of the safety assessment.

2. A method for generating a product information document for a product according to claim 1, wherein: the method further comprises acquiring, by the one or more processors, a value of an amount of the product used by the user of the product in the time period; and acquiring the value of the amount of an ingredient used by the user of the product in the time period comprises determining, by the one or more processors, the amount of that ingredient used by the user of the product in the time period based on the amount of the product used by the user of the product in the time period and the product ingredient list.

3. A method for generating a product information document for a product according to claim 2, wherein determining the amount of an ingredient used by the user of the product in the time period comprises using the amount of the product used by the user of the product in the time period and a proportion of that ingredient in the product, the proportion of that ingredient in the product being specified in the product ingredient list.

4. A method for generating a product information document for a product according to claim 2 or 3, wherein: the method further comprises: displaying, by a display operatively coupled to the one or more processors, a plurality of different product types; and receiving, by the one or more processors, a selection of a product type from the plurality of different product types; and acquiring the value of the amount of the product used by the user of the product in the time period is based on the selected product type.

5. A method for generating a product information document for a product according to any of claims 1 to 4, wherein: the method further comprises: displaying, by a display operatively coupled to the one or more processors, a plurality of different user types; and receiving, by the one or more processors, a selection of a user type from the plurality of different user types; and acquiring the value of a physical property of the user is based on the selected user type.

6. A method for generating a product information document for a product according to claim 5 when dependent on claim 4, wherein acquiring the value of the amount of the product used by the user of the product in the time period is based on the selected product type and the selected user type.

7. A method for generating a product information document for a product according to any of claims 1 to 6, wherein the one or more physical properties of the user include a mass of the user.

8. A method for generating a product information document for a product according to any of claims 1 to 7, wherein the one or more physical properties of the user include a dermal absorption of the user.

9. A method for generating a product information document for a product according to any of claims 1 to 8, wherein the one or more exposure values for an ingredient includes a systemic exposure dose (SED) for that ingredient.

10. A method for generating a product information document for a product according to claim 9, wherein the SED for an ingredient is determined in terms of volume of that ingredient used by the user per unit mass of the user per day.

11. A method for generating a product information document for a product according to claim 9 or 10, wherein the product information file includes at least one determined SED.

12. A method for generating a product information document for a product according to any of claims 1 to 11, wherein: the method further comprises, acquiring, by the one or more processors, for one or more ingredients in the ingredient list, a no observed adverse effect level (NOAEL) for that ingredient; and the safety assessment is based on the acquired one or more NOAELs.

13. A method for generating a product information document for a product according to any of claims 1 to 12, wherein the safety assessment comprises determining, by the one or more processors, for one or more ingredients, a Margin of Safety (MOS) value for that ingredient.

14. A method for generating a product information document for a product according to claim 13, wherein the MOS for an ingredient is determined based on a no observed adverse effect level (NOAEL) for that ingredient and a systemic exposure dose (SED) for that ingredient.

15. A method for generating a product information document for a product according to claim 14, wherein determining the MOS for an ingredient comprises dividing the NOAEL for that ingredient by the SED for that ingredient.

16. A method for generating a product information document for a product according to any of claims 13 to 15, wherein the product information file includes at least one determined MOS.

17. A method for generating a product information document for a product according to any of claims 13 to 16, wherein the safety assessment comprises: acquiring, by the one or more processors, for one or more ingredients, a threshold for the MOS for that ingredient; and comparing, by the one or more processors, for one or more ingredients, the MOS for that ingredient to the acquired MOS threshold for that ingredient.

18. A method for generating a product information document for a product according to claims 17, wherein the safety assessment further comprises assigning, by the one or more processors, to one or more of the ingredients, a safety label depending on the comparison of the MOS for that ingredient to the acquired MOS threshold for that ingredient.

19. A method for generating a product information document for a product according to claims 17 or 18, wherein: a first safety label is assigned to an ingredient if the MOS for that ingredient is less than or equal to the MOS threshold for that ingredient; and a second safety label is assigned to an ingredient if the MOS for that ingredient is greater than the MOS threshold for that ingredient.

20. A method for generating a product information document for a product according to claim 19, wherein the first safety label indicates an unsafe ingredient.

21. A method for generating a product information document for a product according to claim 19 or 20, wherein the second safety label indicates a safe ingredient.

22. A method for generating a product information document for a product according to any of claims 17 to 21, wherein, for one or more ingredients, the MOS threshold for that ingredient is 100.

23. A method for generating a product information document for a product according to any of claims 17 to 22, wherein, for one or more ingredients, the MOS threshold for that ingredient is greater than 100.

24. A method for generating a product information document for a product according to any of claims 17 to 23, wherein, for one or more ingredients, the MOS threshold for that ingredient is less than 100.

25. A method for generating a product information document for a product according to any of claims 17 to 24, wherein, for one or more ingredients, the MOS threshold for that ingredient is 10.

26. A method for generating a product information document for a product according to any of claims 17 to 25, wherein, for one or more ingredients, the MOS threshold for that ingredient is in the range 1 to 10.

27. A method for generating a product information document for a product according to any of claims 17 to 26, wherein, for one or more ingredients, the MOS threshold for that ingredient is 1.

28. A method for generating a product information document for a product according to any of claims 17 to 27, wherein acquiring an MOS threshold comprises: acquiring, by the one or more processors, an interspecies variability factor; and determining, by the one or more processors, the MOS threshold using the interspecies variability factor.

29. A method for generating a product information document for a product according to claim 28, wherein the interspecies variability factor is between 1 and 10.

30. A method for generating a product information document for a product according to any of claims 17 to 29, wherein acquiring an MOS threshold comprises: acquiring, by the one or more processors, an intraspecies variability factor; and determining, by the one or more processors, the MOS threshold using the intraspecies variability factor.

31. A method for generating a product information document for a product according to claim 30, wherein the intraspecies variability factor is between 1 and 10.

32. A method for generating a product information document for a product according to any of claims 1 to 31, wherein the one or more physical properties of the user include a surface area of at least part of the user.

33. A method for generating a product information document for a product according to any of claim 1 to 32, wherein: the method further comprises: displaying, by a display operatively coupled to the one or more processors, one or more different use scenarios for the product, each use scenario specifying one or more body parts of the user; and receiving, by the one or more processors, a selection of a use scenario from the plurality of different use scenarios; and acquiring the value of a physical property of the user comprises acquiring a value of a surface area of at least part of the user based on the selected use scenario.

34. A method for generating a product information document for a product according to claim 33 when dependent on claim 4, wherein: the method further comprises providing a plurality of different use scenarios, each use scenario in the plurality of use scenarios corresponding to a respective one or more different product types; and the displayed use scenarios are only those use scenarios that correspond to the selected product type.

35. A method for generating a product information document for a product according to claim 33 or 34 when dependent on claim 5, wherein acquiring a value of a surface area of at least part of the user is based on the selected use scenario and based on the selected user type.

36. A method for generating a product information document for a product according to any of claims 1 to 35, wherein the one or more exposure values for an ingredient includes a skin exposure value for that ingredient, the skin exposure value for an ingredient being indicative of an amount of that ingredient per unit of area of the user’s skin is that exposed to that ingredient within the time period.

37. A method for generating a product information document for a product according to claim 36, wherein the skin exposure value for an ingredient is determined in terms of milligrams of that ingredient used by the user per square-centimetre of skin of the user to which that ingredient is applied per day.

38. A method for generating a product information document for a product according to claim 36 or 37, wherein the product information file includes at least one determined skin exposure value for an ingredient.

39. A method for generating a product information document for a product according to any of claims 1 to 38, wherein: the method further comprises, acquiring, by the one or more processors, for one or more ingredients in the ingredient list, a local no observed adverse effect level (NOAEL) for that ingredient, a local NOAEL for an ingredient being a NOAEL for that ingredient for an area of a user’s skin; and the safety assessment is based on the acquired one or more local NOAELs.

40. A method for generating a product information document for a product according to claim 39 when dependent on claim 37, wherein the safety assessment comprises determining, by the one or more processors, a safety value for that ingredient, a safety value for an ingredient being the local NOAEL for that ingredient and the skin exposure value for that ingredient.

41. A method for generating a product information document for a product according to claim 40, wherein determining the safety value for an ingredient comprises dividing the local NOAEL for that ingredient by the skin exposure value for that ingredient.

42. A method for generating a product information document for a product according to any of claims 40 or 41, wherein the product information file includes at least one determined safety value.

43. A method for generating a product information document for a product according to any of claims 40 to 42, wherein the safety assessment comprises: acquiring, by the one or more processors, for one or more ingredients, a threshold for the safety value for that ingredient; and comparing, by the one or more processors, for one or more ingredients, the safety value for that ingredient to the acquired safety value threshold for that ingredient.

44. A method for generating a product information document for a product according to claims 43, wherein the safety assessment further comprises assigning, by the one or more processors, to one or more of the ingredients, a safety label depending on the comparison of the safety value for that ingredient to the acquired safety value threshold for that ingredient.

45. A method for generating a product information document for a product according to claims 43 or 44, wherein: a third safety label is assigned to an ingredient if the safety value for that ingredient is less than or equal to the safety value threshold for that ingredient; and a fourth safety label is assigned to an ingredient if the safety value for that ingredient is greater than the safety value threshold for that ingredient.

46. A method for generating a product information document for a product according to claim 45, wherein the third safety label indicates an unsafe ingredient.

47. A method for generating a product information document for a product according to claim 45 or 46, wherein the fourth safety label indicates a safe ingredient.

48. A method for generating a product information document for a product according to any of claims 1 to 47, the method further comprising: providing a list of allergens; and identifying, by the one or more processors, using the product ingredient list, each allergen in the product.

49. A method for generating a product information document for a product according to claim 48, wherein the product information file includes a list of identified allergens in the product.

50. A method for generating a product information document for a product according to claim 48 or 49, wherein the method further comprises: acquiring, by the one or more processors, a threshold amount for each allergen present in the product; generating a warning flag for each allergen in the product that exceeds the threshold amount corresponding to that allergen; and including the generated warning flags in the product information document.

51. A method for generating a product information document for a product according to claim 50, wherein the method further comprises determining, by the one or more processors, for one or more of the identified allergens present in the product, one or more further exposure values, each further exposure value being indicative of an exposure of the user to that allergen during the time period; and the safety assessment is performed based on the determined one or more further exposure values.

52. A method for generating a product information document for a product according to claims 51, wherein the one or more exposure values for an allergen includes a skin exposure value for that allergen, the skin exposure value for an allergen being indicative of an amount of that allergen per unit of area of the user’s skin that is exposed to that allergen within the time period.

53. A method for generating a product information document for a product according to claim 52, wherein the skin exposure value for an allergen is determined using a dermal absorption value of the skin of the user.

54. A method for generating a product information document for a product according to claim 52 or 53, wherein the product information file includes at least one determined skin exposure value for an allergen.

55. A method for generating a product information document for a product according to any of claims 52 to 54, wherein the safety assessment comprises: acquiring, by the one or more processors, for one or more of the identified allergens present in the product, a threshold for the skin exposure value for that allergen; and comparing, by the one or more processors, for one or more of the identified allergens present in the product, the skin exposure value for that allergen to the acquired skin exposure value threshold for that allergen.

56. A method for generating a product information document for a product according to claim 55, wherein the safety assessment further comprises assigning, by the one or more processors, to one or more of the identified allergens present in the product, a safety label depending on the comparison of the skin exposure value for that allergen to the acquired skin exposure value threshold for that allergen.

57. A method for generating a product information document for a product according to claims 55 or 56, wherein: a fifth safety label is assigned to an allergen present in the product if the skin exposure value for that allergen is greater than or equal to the acquired skin exposure value threshold for that allergen; and a sixth safety label is assigned to an allergen present in the product if the skin exposure value for that allergen is less than the acquired skin exposure value threshold for that allergen.

58. A method for generating a product information document for a product according to claim 57, wherein the fifth safety label indicates an unsafe ingredient.

59. A method for generating a product information document for a product according to claim 57 or 58, wherein the sixth safety label indicates a safe ingredient.

60. A method for generating a product information document for a product according to any of claims 1 to 59, wherein: the method further comprises acquiring, by the one or more processors, regulatory information for one or more of the ingredients in the product ingredient list; and the safety assessment is based on the acquired regulatory information.

61. A method for generating a product information document for a product according to claim 60, wherein at least one threshold from a set of thresholds is dependent on the regulatory information, the set of thresholds consisting of: an MOS threshold, a safety value threshold for an ingredient, a safety value threshold for an allergen, and an allergen threshold amount.

62. A method for generating a product information document for a product according to claim 60 or 61, wherein: the method further comprises: displaying, by a display operatively coupled to the one or more processors, a plurality of different jurisdictions; and receiving, by the one or more processors, a selection of a jurisdiction from the plurality of different jurisdictions; and acquiring the regulatory information is based on the selected jurisdiction.

63. A method for generating a product information document for a product according to claim 62, wherein product information document is generated in a format based on the selected jurisdiction.

64. A method for generating a product information document for a product according to any of claims 1 to 63, the method further comprising receiving, by the one or more processors, from an operator interface operatively coupled to the one or more processors, the product ingredient list.

65. A method for generating a product information document for a product according to any of claims 1 to 64, the method further comprising displaying, on a display operatively coupled to the one or more processors, the generated product information document.

66. A method for generating a product information document for a product according to any of claims 1 to 65, the method further comprising reformulating the product based on the generated product information document.

67. Apparatus for generating a product information document for a product, the apparatus comprising one or more processors configured to: acquire a product ingredient list for the product; acquire, for one or more ingredients in the ingredient list, a value of an amount of that ingredient used by a user of the product in a time period; acquire, for one or more physical properties of the user, a value of that physical property of the user; determine, for one or more ingredients in the ingredient list, using the value of the amount of that ingredient used by a user of the product in the time period and the one or more physical property values, one or more exposure values, each exposure value being indicative of an exposure of the user to that ingredient during the time period; perform a safety assessment based on the determined one or more exposure values; and generate a product information file including the results of the safety assessment.

68. A computer program stored in a computer readable storage medium that, upon execution by a processor, cause the processor to: acquire a product ingredient list for a product; acquire, for one or more ingredients in the ingredient list, a value of an amount of that ingredient used by a user of the product in a time period; acquire, for one or more physical properties of the user, a value of that physical property of the user; determine, for one or more ingredients in the ingredient list, using the value of an amount of that ingredient used by a user of the product in the time period and the one or more physical property values, one or more exposure values, each exposure value being indicative of an exposure of the user to that ingredient during the time period; perform a safety assessment based on the determined one or more exposure values; and generate a product information file including the results of the safety assessment.

69. A program or plurality of programs arranged such that when executed by a computer system or one or more processors it/they cause the computer system or the one or more processors to operate in accordance with the method of any of claims 1 to 66.

70. A machine readable storage medium storing a program or at least one of the plurality of programs according to claim 69.

71. A product information document for a product generated using a method according to any of claims 1 to 66.

72. A method for generating a product information document for a product as substantially described herein with reference to the accompanying drawings.

73. Apparatus for generating a product information document for a product as substantially described herein with reference to the accompanying drawings.