On October 5, 2023, UK released a guidance introducing the management of CMR substances (those classified as carcinogenic, mutagenic or toxic for reproduction) within the cosmetics regulatory framework. Applicable to England, Scotland, and Wales, the guidance outlines the regulatory requirements for CMR substances, and describes the exemption application process for their continued use.

Regulatory Requirements for CMR Substances

Article 15 of the UK Regulation (EC) 1223/2009 (Cosmetics Regulation) sets out provisions on the use of CMR substances in cosmetics. To ensure comprehensive protection of human health, CMR substances categorized as 1A, 1B, and 2 in the following documents are prohibited for use in cosmetics:

• The Regulation 1272/2008 on Classification, Labelling and Packaging of Substances and Mixturein Great Britain (GB CLP Regulation);
• The GB Mandatory Classification and Labelling List (GB MCL List).

However, where an exemption has been granted by the Secretary of State (SoS), such substances can be permitted for use in cosmetics. The exemption can only happen when an application is submitted by an interested party and when all the criteria for exemption listed in Article 31 of the UK Cosmetics Regulation are fulfilled.

Exemption Application for CMR Substances

For CMR substances that meet the exemption criteria above, interested parties intending to apply for exemption should submit their applications to the Office for Product Safety and Standards (OPSS) via email at cmrenquiries@beis.gov.uk. In the application, any scientific data submitted for the safety assessment should include all relevant elements as prescribed in The SCCS Notes of Guidance for the Testing of Cosmetic Ingredients and Their Safety Evaluation. Besides, it is required to submit original study reports and literature in full for all data referred to in the safety assessment. Confidential and commercially sensitive data should only be submitted if it is relevant to the exemption application, and be clearly marked in the submission.

Articles 37 and 37A of the GB CLP Regulation establish two procedures for substances to receive a mandatory 1A, 1B or 2 CMR classification, and be added to the GB MCL List by the Health and Safety Executive (HSE). During each procedure, a GB MCL Technical Report concerning the CMR substance is published at a specific step. Interested parties should submit their exemption application no later than 18 months from the date of the Technical Report’s publication. Upon receiving the application, OPSS requires an additional 12 months to conduct a substance evaluation. Following the evaluation, the substances deemed eligible for exemption will be included in the restricted or permitted ingredient lists, while those considered ineligible will be added to the prohibited ingredient list.

Further Reading

• UK to Impose Restrictions on the Use of Butylated Hydroxytoluene
• UK SAG-CS Publishes Opinions on Butylated Hydroxytoluene and Kojic Acid
• EU REACH to Restrict Intentionally-added Microplastics in Cosmetics

ChemLinked Cosmetic Portal (cosmetic.chemlinked.com) is a media platform operated by REACH24H Consulting Group. Our focus is on providing comprehensive one-stop-market access information services and solutions to members of the cosmetics industry, including domestic and foreign manufacturers, trade logistics, raw material companies, as well as government departments, industry associations, and research institutions.

We offer a wide range of global cosmetic market entry services, including Global News Alerts, Cosmetics Product Registration and Notification, New Cosmetic Ingredient (NCI) Registration/Notification, Regulatory Consultation, Customized Training, Market Research, and Branding Strategy. Please contact us to discuss how we can help you by cosmetic@chemlinked.com

EU adopts the 12th Revision of the SCCS notes of guidance for the testing of cosmetic ingredients and their safety evaluation

On May 16, 2023, EU Scientific Committee on Consumer Safety (SCCS) released the 12th Revision of The SCCS Notes of Guidance for the Testing of Cosmetic Ingredients and Their Safety Evaluation (the Notes of Guidance). Compared to its predecessor, the newly released Notes of Guidance provides updates on animal-free alternative testing methods, emphasizes aggregate exposure and children’s exposure in specific ingredients’ assessments, and gives instructions on assessing children’s exposure to cosmetics.

The Notes of Guidance

SCCS is an independent advisory body that offers opinions on the health and safety risks of non-food consumer products. One of its responsibilities is to recommend a set of guidelines for developing adequate studies used in the safety evaluation of cosmetic ingredients. This is done through the Notes of Guidance, a document that introduces different aspects of the testing and safety evaluation of cosmetic ingredients. While its emphasis is on ingredients, it also gives indirect guidance for the safety assessment of finished products.

To incorporate new knowledge as well as scientific and regulatory advances, the Notes of Guidance is regularly updated. Its most recent revision, SCCS/1628/21, was carried out in 2021. After that, several new addenda, opinions and memoranda that are important to the guidance’s content were adopted. On this basis, the 12th revision of Notes of Guidance is formed.

Highlights of the 12th Revision

Compared to the 11th revision, the new revision makes the following main changes:

1. Updating Animal-free Alternative Testing Methods

Regarding cosmetics and their ingredients, testing and marketing bans are in place to prohibit the use of animals. Additionally, there is an obligation to use only validated replacement alternatives. This is why for validated animal-free alternative methods for chemical hazard assessment, it is much harder to achieve compliance to Regulation (EC) No 1223/2009 (the Cosmetics Regulation) than with other regulatory frameworks in Europe.

Given the testing and marketing bans imposed by the Cosmetics Regulation, SCCS pays special attention to alternative methods that are suitable for the safety testing of cosmetic ingredients, and regularly updates the Notes of Guidance. In the 12th revision, SCCS provides updates on alternative methods to reflect the changes in this area, introducing changes for acute inhalation toxicity testing, skin irritation testing, defined approaches for eye irritation testing and skin sensitisation, as well as new in vitro methods for genotoxicity testing.

2. Emphasizing Aggregate Exposure and Children’s Exposure in the Assessment for Specific Ingredients

Endocrine disruptor (ED) refers to a substance or a mixture that alters one or more functions of the endocrine system, and consequently causes adverse effects in an intact organism, its progeny, populations or subpopulations. On March 31, 2023, the Commission Delegated Regulation (EU) 2023/707 formally introduced endocrine disruptor as a new hazard category. Following this formal introduction, the 12th revision underlines that when a cosmetic ingredient is suspected of having potential endocrine properties, SCCS will assess its risk for children according to age, taking into consideration the relevant cosmetic categories to which children of different ages are commonly exposed.

CMR substances are those classified as carcinogenic, mutagenic, or toxic for reproduction. Depending on properties, they are grouped under Category 1A, Category 1B and Category 2. As a general principle, CMR substances are banned for use in cosmetics. Exceptionally, they may be used in cosmetic under specific conditions where they have been evaluated safe by SCCS.

For CMR substances of Category 1A and 1B, the aggregate exposure from all sources shall be taken into consideration during the safety evaluation. This means that, as clarified by the 12th revision, not only the amount of the ingredient used in all cosmetic categories, but also the amounts coming from other sources (e.g., food, pesticides, industrial chemicals, etc.) should be considered. Moreover, the new revision adds that, since children are vulnerable, the safety assessment shall also take into consideration the exposure of children of different age groups.

3. Giving Instructions on Assessing Children’s Exposure to Cosmetics

To give a useful reference for safety assessors and agencies, Appendix 7 to the Notes of Guidance includes a literature overview of recent consumer exposure data of cosmetics, including different categories of cosmetics, frequency of use, amount per application, and amount per day. The data covers consumers from one or more particular countries and, in some cases, are stratified by age, gender, and cosmetic formulation. However, there is a lack of exposure data of cosmetic products for children of different age groups.

As mentioned above, the 12th revision draws attention to the exposure of children of different age groups when assessing the safety of EDs and CMR substances. In line with this focus, the 12th revision introduces recent studies and available data for calculating children’s exposure. Based on this, it further provides an example of different cosmetic categories to which children of different ages may be exposed.

In addition to these main changes, the 12th revision of the Notes of Guidance explains the rationale behind the exposure data used to evaluate sunscreen’s sun protection, stresses the importance of systematic literature review and the potential of in silico prediction, as well as introduces templates for describing Physiologically Based ToxicoKinetics (PBTK) models, parameter verification and analysis. Details of these changes can be found here.

Further Reading

• Cosmetics Regulation Focus: What Are the Impacts of the EU Chemicals Strategy for Sustainability?
• EU SCCS Releases Preliminary Opinion on Children’s Exposure to Methyl Salicylate
• EU SCCS Updates the Scientific Advice on HC Blue 18

ChemLinked Cosmetic Portal (cosmetic.chemlinked.com) is a media platform operated by REACH24H Consulting Group. Our focus is on providing comprehensive one-stop-market access information services and solutions to members of the cosmetics industry, including domestic and foreign manufacturers, trade logistics, raw material companies, as well as government departments, industry associations, and research institutions. We offer a wide range of global cosmetic market entry services, including Global News Alerts, Cosmetics Product Registration and Notification, New Cosmetic Ingredient (NCI) Registration/Notification, Regulatory Consultation, Customized Training, Market Research, and Branding Strategy. Please contact us to discuss how we can help you by cosmetic@chemlinked.com

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BROWSE SHOWS

One of the dilemmas of any formulator, chemist or brand owner is to ensure they choose the right ingredients in compliance with the regulatory criteria for the relevant market in the foreseeable future to avoid reformulating costs and supply chain nightmares.

On the other hand, the regulatory landscape is ever changing due to new knowledge in the field of toxicology and developing new tests’ methods to evaluate ingredients’ safety.

In this article, we will discuss the substances that are being restricted in the EU zone (27 countries) while being placed on the market in 2022.

Based on the EU regulatory format for updating ingredients’ safety, any new information will be submitted to the Scientific Committee on Consumer Safety (SCCS). This committee consists of several experienced experts in the field of human safety and toxicology and provides opinions on consumers’ safety based on the latest information. The committee usually provides its reports in response to a specific request.

The EU Commission, in 2020, committed to creating a priority list of potential endocrine disruptors that weren’t covered yet by the regulation bans under substances classified as carcinogenic, mutagenic, or toxic for reproduction (CMR). After input from EU countries, the industry, consumer organisations and the SCCS, the Commission consolidated a list of 28 substances. Many of substances in this list were reviewed by the SCCS based on the latest available data. Hence, we are expected to have several new restrictions in 2022.

Dihydroxyacetone (DHA): One of the hot topics in the regulatory field in 2022 is the restriction in concentration of this ingredient which affects self-tanning products.   Dihydroxyacetone is the aliphatic ketone, known in the industry as DHA. It is a common ingredient that may be found in many tanning and hair dye products.

This ingredient is not known to be a skin sensitiser or irritant to eyes and has a low acute toxicity profile. In 2008, The Scientific Committee on Consumer Safety (SCCS) concluded that, based on available data, the use of DHA as self-tanning ingredients can be considered as safe by 10% and safe up to 14% in the spray cabin.

However, considering the new data submitted to the commissioner in 2019, the SCCS has reviewed its previous opinion and came to the conclusion that the use of DHA as hair colourant in non-oxidative hair products (leave on) is safe to maximum concentration on 6.25% together with self-tanning lotion and face cream to a maximum of 10% in finished products.

This opinion turned into regulation from 26.02.2022 and there should be NO product available on the market from 22^nd May 2022 that contains DHA concentration above the set criteria. This regulation is only applicable in the EU and Northern Ireland and is not yet confirmed in the UK.

Methyl salicylate: It is the ester of methyl alcohol and salicylic acid and it is mainly used in cosmetic products as denaturant, flavouring, oral care, perfuming and soothing. Based on new evaluation and recent studies, the SCCS (SCCS 1633/21) has considered this ingredient as a skin sensitiser.

Since metabolic products of Methyl salicylate in the body are a salicylic acid and this ingredient is considered as a CMR 2 (reprotoxic); hence the accumulative exposure to cosmetic products containing various salicylates may impact the final safe level for consumers.

Based on this opinion, there will be a new restriction for this ingredient in various products placed on the market from Dec 2022. The below table will explain the new restriction based on each cosmetic category:

Benzophenone-3 and Octocrylene: UV filters used in cosmetic products follow the restriction set in annexe VI. If an ingredient is not listed in annex VI, it cannot be used in a formulation as a UV filter. From the annex VI, these two ingredients were listed in the EU commission priority list A for immediate review in 2021.

Octocrylene: It is the substituted acrylate listed under Annex VI (10), a light stabiliser and UV filter. Based on the recent SCCS review (SCCS 1627/21), the Committee did not consider the current evidence for octocrylene endocrine effect sufficient. The reported contact sensitiser for this ingredient was evaluated as negligible due to its widespread use and considered it as negligible.

Based on cumulative exposure, the SCCS restricted the use of this ingredient in propellant spray to 9% (from previous 10%) when used together with face cream, lip cream and hand cream containing 10% Octocrylene.

Benzophenone-3 (BP-3): This ingredient is a benzophenone derivative listed under UV filter (Annex VI/4) and as a light stabiliser function (not in annex VI). The SCCS did not consider the presented evidence as sufficient to list this substance under CMR category. However, the committee warrants further investigation. Previously this ingredient was allowed to be used by 6% (2017/238) and not more than 0,5 % to protect product formulation. Based on the new SCCS opinion (1625/20), the new restrictions are:

-Face products, hand products, and lip products, excluding propellant and pump spray products (6%: unchanged)

-Body products, including propellant and pump spray products (limited to 2.2%)

The limitation for its concentration for any other function remains at 0.5% and the warning statement should be on the label (no change on this statement) as: Contains Benzophenone-3

The restriction for both BP-3 and Octocrylene are expected to take place from third quarter in 2022.

Methyl-N-methylanthranilate (M-N-MA): It is a fragrance ingredient used in various cosmetics, including fine fragrances, shampoos, soaps, and other toiletries. Previously it was considered as safe at concentration up to 0.2% in rinse-off and 0.1% at leave-on products.

The safety concern for this ingredient was raised when being used on areas exposed to light. M-N-MA has phototoxic properties but based on the provided data using this substance with concentrations from 0.1% to 0.5% with a UV dose that realistically represents skin exposure during outdoor activities (excluding sunbathing) should not result into any phototoxic reactions.

However, the SCCS (SCCS/1616/20) did not consider this ingredient as safe when being used in sunscreen products and products marketed for exposure to natural/artificial UV light, due to possibilities of prolonged exposure. This restriction will come into place in the third quarter in 2022.

In the next part of this article, we will discuss the substances that are to be banned in 2022.

Personal Care Regulatory Ltd make sure to track ingredients restriction and update their clients’ safety assessment reports on time and regularly.

Get in touch with them for further discussion at: info@personalcareregulatory.com

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In the EU, the manufacture of cosmetics is governed by the EU Cosmetics Regulation. Born as The Cosmetics Directive in 1976, the Directive saw revisions in 2009 before becoming the Cosmetics Product Regulation in 2013. The version we know today spans the entire EU network in order to meet Single Market standards.

The European Single Market is a trade deal between the EU countries which attempts to make trading between member nations as easy as possible. In order for it to work for a specific product sector, there needs to be similar legislation for all member states. Applying this to the cosmetics landscape, the same labelling, packaging and safety regulations must apply across borders in order for products to be transported and sold without restrictions in the EU.

Assuming the relevant standards are met, a person or company can place their cosmetic product on the market. In turn, that person, who is usually a manufacturer or distributor, becomes that product’s Responsible Person (RP) and takes on responsibility for product safety and Cosmetics Regulation compliance.

The same standards apply to ingredients, all of which are governed by the EU Cosmetics Regulation. From banned substances with too much toxicity to pre-approved substances suitable for UV filters and the like, every product needs to meet extensive product and safety assessments.

The EU Cosmetics Regulation orders that all cosmetics products must be manufactured in accordance with the Good Manufacturing Practice (GMP), which sets out that products should be prepared in a clean environment to prevent contamination.

The final step on the road to market takes us to the Cosmetic Products Notification Portal (CPNP), managed by the European Commission. This instructs that all cosmetics products on the European market must be recorded on a centralised database.

There are lots of regulation talks happening at in-cosmetics Global 2020. Come to our skin microbiome regulation workshop.The post Your guide to EU cosmetics regulations first appeared on in-cosmetics Connect.]]> https://connect.in-cosmetics.com/regions/global/your-guide-to-eu-cosmetics-regulations/feed/ 0 7862 https://connect.in-cosmetics.com/regions/global/achieve-compliance-following-the-eu-cosmetics-regulation/ https://connect.in-cosmetics.com/regions/global/achieve-compliance-following-the-eu-cosmetics-regulation/#respond Thu, 21 May 2020 07:23:30 +0000 http://ec2-52-48-9-53.eu-west-1.compute.amazonaws.com/?p=7859 In the three years since the EU Cosmetics Regulation amendments were legalised in Europe, we recap the changes we’ve seen surrounding EU Cosmetics Regulation. The regulations were brought in to simplify the regulatory requirements across each member state with unified intentions of improving product safety, reducing business costs and minimising legal uncertainties. Below we detail […]