By the time you read this, we are welcoming spring in the northern hemisphere and looking forward to summer. However, I spent two cold but sunny winter days in London at the Sun Protection Conference at the end of November last year (2023), where concerns were raised about consumers’ confusion over sunscreen labeling. These concerns and some of the actions being taking to address them are described in this latest installment of the EU Regulatory Update.
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By the time you read this, we are welcoming spring in the northern hemisphere and looking forward to summer. However, I spent two cold but sunny winter days in London at the Sun Protection Conference at the end of November last year (2023), where concerns were raised about consumers’ confusion over sunscreen labeling. These concerns and some of the actions being taking to address them are described in this latest installment of the EU Regulatory Update.
Also discussed are REACH and its involvement with the Department for Food and Rural Affairs (DEFRA). Furthermore, the upcoming CMR process, ingredient management and product safety reviews in the UK are covered, followed by the Cosmetic, Toiletry and Perfumery Association’s (CTPA’s) manifesto.
Sunscreen Labeling
The Sun Protection Conference, as noted, was held at the end of November last year. The scientific program was entitled, “A Decade of Challenge – The Uncertain Future of Sun Protection,” and covered themes ranging from the necessity of sun protection, the science and burden of UVR-induced skin cancer/photoaging, challenges to our UV filter palette over the next 10 years, sun testing and labeling, and more.
I found the talks inspirational and it was good to hear about work being done to boost confidence in UV filters from both an environmental and human health perspective. But I also heard several concerning themes emerge, including confusion over sunscreen labeling, lack of trust in the industry and how can we communicate better.
As an honored speaker, I shared a personal view of what the future for sunscreen labeling could and should hold. My insights were based on the results of a 2015 survey conducted in the UK by the Royal Pharmaceutical Society (RPS). The survey asked consumers about sunscreens and their understanding of them.
The baseline was poor, with only 14% of those polled saying they always apply sunscreen in sunny weather. Another 30% stated they applied it often, while 32% stated “sometimes.” Also, only 31% checked for UVA protection – but maybe that was because 56% of people thought SPF protected against both UVA and UVB.
The chief scientist for the RPS at the time of the survey, Professor Jayne Lawrence, stated: “This survey indicates that there is a huge amount of confusion around sunscreen labeling that is a barrier to effective sun protection. … People should not have to pick their way through complicated dual ratings information to understand how sunscreen works and the amount of protection it potentially provides. We think it’s time for sunscreen manufacturers to provide one easy to understand rating, based on a simple description of the total amount of sun protection offered: low, medium, high and very high protection.” I must confess, I agreed with Professor Lawrence then and I agree now – eight years on from that survey.
The future of sunscreen labeling is under discussion by Cosmetics Europe, the European personal care association. The Strategic Advisory Group on Sun Products at Cosmetics Europe has a comprehensive strategy looking at the available palette of UV filters – mainly at an EU and UK level, but also with a global perspective.
The group is also exploring the future of labeling and communication, and has commissioned consumer polling to see if there is any change in consumers’ understanding across the European Union since the RPS survey in 2015. It is an interesting discussion that has significant implications globally. However, to me it feels right to be having this conversation to ensure sunscreens are as easy as possible to understand, buy and use.
UK REACH
In the last EU/UK Regulatory Update column of 2023,1 I highlighted several ingredient actions under the EU Registration, Evaluation and Authorization of Chemicals regulation (REACH) and their implications under the UK REACH UK REACH, while based heavily on EU REACH, does mean some different obligations for UK downstream users,2 due to the impact of definitions. It is important for companies to understand how the legal responsibilities apply to the various actors within the cosmetic supply chain. This is because the obligations under the REACH system are determined by the company’s role regarding the individual ingredients.
Importantly, the definition of “Importer” may now cover companies classed as Downstream users (DUs) — companies or individual workers that use chemicals, which include companies who manufacture goods or offer services which might not always be linked directly with chemicals and might include the use of chemicals in professional applications. Many DUs would not have been classed as importers under EU REACH when the UK was a member of the EU and part of a single market. Therefore, Dus may now have more obligations under UK REACH, including having to submit a Downstream User Import Notification (DUIN) via the UK REACH IT system and possibly full registration requirements.
UK REACH needs to ensure a high level of protection for human health and the environment, however I believe it must also be proportionate and workable for businesses.
The CTPA advocated for the introduction of phased registration submissions similar to the EU REACH. These were granted by the Department for Food and Rural Affairs (DEFRA), taking the registration submissions in the UK to 2026, 2028 and 2030. These extended deadlines will allow the UK REACH to develop a registration model and educate companies to ensure compliance. The CTPA has continued its engagement with DEFRA on this matter.
At the end of last year (2023), DEFRA published a policy paper3 on the Alternative Transitional Registration model (ATRm) for the UK. In the following statement, DEFRA reassured the industry: “The ATRm will aim to reduce the costs to businesses while continuing to ensure our overarching commitment to high levels of protection of human health and the environment.”
It added, “it has become evident as part of the review that our regulators do not need to hold a complete replica of all the registration data on all chemical substances held under EU REACH in order for UK REACH to undertake its regulatory work. We can adopt a more targeted approach by using information already available and building on work done in the EU and globally to identify areas of emerging risk and shape our regulatory priorities. This will allow us to develop the detailed information we hold on chemical substances in a more targeted way.”
The full proposal is to be issued for public consultation this year.
UK Ingredient Management
The CTPA also has been working closely with the Office for Product Safety and Standards (OPSS), the UK regulator for cosmetic products, to ensure that the way ingredients are managed in the UK is clearly highlighted to the industry. While ingredient management has been expected to follow a similar process in the EU, this has been clarified by OPSS.
The use of ingredients in cosmetic products in the UK is controlled though annexes to the UK Cosmetics Regulation (UKCR). The decision to include an ingredient in either the prohibited or restricted lists (Annex II and Annex III, respectively) will be based on scientific evidence and the level of risk to human health. Annexes to the UKCR are amended via secondary legalization in the form of statutory instruments.
Scientific scrutiny is given via the Scientific Advisory Group on Chemical Safety of Non-Food and Non-Medicinal Consumer Products (SAG-CS), which was established in March of 2021. Similar to the SCCS (Scientific Committee on Consumer Safety) in the EU, SAG-CS’s remit is to provide independent scientific advice and risk assessments.
When an ingredient has been identified for review in the UK, OPSS will launch a call for data. Interested parties can submit a body of evidence to support the safe use of the ingredient for consideration by SAG-CS. After SAG-CS has issued its opinion on the data, this will be used as part of the evidence to be reviewed when making any regulatory changes.
In addition to general ingredient management, in October 2023, OPSS published the process4 to manage substances classed as CMR (carcinogen, mutagen, reprotoxic) under the UK Cosmetics Regulation (UKCR).
Background: Article 15 of the UKCR bans the use of substances classed as CMR under the GB Mandatory Classification List (MCL) of the GB Classification Labeling and Packaging (CLP) regulation. However, some of these substances may still be used in cosmetic products under specific exemption criteria outlined in Article 15 of the UKCR.
UK CMR process: The CMR management process under the UKCR considers the key steps and timelines of the GB MCL.
- Companies shall submit to OPSS an exemption application (defense dossier) within 18 months from the publication of the technical report proposing a GB MCL under GB CLP for a substance used as a cosmetic ingredient. This is for both workstreams for the GB MCL process.
- The exemption application shall be submitted to [email protected]. Any scientific data submitted for the safety assessment must include all relevant elements as prescribed in the Scientific Committee on Consumer Safety Notes of Guidance for the Testing of Cosmetic Ingredients and Their Safety Evaluation. Note that SAG-CS will use 70 kg as their default bodyweight assumption for adults in new safety assessments.
- The exemption application shall be evaluated by OPSS and the SAG-CS within 12 months after receipt of the exemption dossier by the industry.
- The UKCR annexes shall be amended to implement a ban or restriction (if defense by industry is successful) within eight months from publication of the SAG-CS opinion.
- It is expected that the entry into force of the UKCR provisions will be aligned with the application date of the GB MCL under GB CLP.
- However, the UKCR will have a six-month transition period for making the available (off-shelf) deadline.
- There can be flexibility on the timelines, depending on any possible delays to the process.
UK Product Safety Review
In 2021, OPSS launched a call for evidence looking at the way that product safety was regulated in the UK after Brexit. The purpose of this call for evidence was to gain intelligence regarding the way these regulations worked for the UK market specifically. The CTPA contributed to this consultation in support of the UK Cosmetics Regulation (UKCR). OPSS issued a report in November 2021.
In August 2023, the Department for Business and Trade (DBT), in which government department OPSS sits, announced5 a consultation: the Product Safety Review (PSR), looking to reshape product safety legislation altogether, including all sectors regulated under OPSS, and bringing them into a common framework with cross-cutting requirements. The UKCR is included as one of the regulations that could be potentially removed in favor of this approach. The consultation was open until October 2023.
The PSR consultation covered the following topics:
1. Vision for a future framework:
- Becoming a global leader in product safety.
2. Bringing products to market:
- Creating an agile, risk-proportionate and innovative framework;
- Potential categorization of products by hazard;
- A more proportionate cross-cutting approach;
- Guidance;
- Supporting supply of critical products in emergencies; and
- Introducing voluntary e-labeling.
3. Online supply chains:
- Tackling the listing and re-listing of unsafe products and
- Strengthening consumer information online.
4. Compliance and enforcement:
- Enhancing the role of OPSS;
- Data and intelligence sharing;
- Recall and incident notification recalls;
- Consolidating and aligning enforcement legislation;
- Introducing new enforcement powers;
- Inspection powers; and
- Creating a fit for purpose product liability regime.
Within the consultation, the UK government included proposals to:
- Replace sector-specific legislation with a common horizontal hazard-based approach for all consumer goods under its responsibility.
- Introduce a derogation process to support access to essential goods during emergency situations.
- Explore options for digital labeling, focusing on devices with screens or to be used with screens and for enforcement purposes.
- Review the rules for online marketplaces to better support consumer safety.
- Enhance the role and leadership of OPSS through measures such as harmonizing enforcement rules and reviewing the product liability regime.
There are potential benefits, including greater consistency across different product categories and a reduction in some challenges around borderline products; a possible reduction in regulatory requirements; the inclusion of opportunities to future-proof UK regulations; and UKCR as an example for other sectors. However, the CTPA and I have grave concerns about the possible impacts on the integrity of the UK market, in particular with supply chain arrangements and the possible need to depart from the current requirement for a safety assessment under the UKCR.
My concerns include:
- Changing the status quo;
- Increased uncertainty;
- Possible additional costs and burdens to the industry; and
- Removing the safety standards and baseline within the UK regulation.
The UKCR provides a level playing field for all cosmetic products placed on the UK market to guarantee consumer safety and promote the trust and reputation of the industry.
The CTPA submitted a robust response6 to the PSR consultation, stating the UK cosmetics industry considers that the UKCR meets the objectives of ensuring consumer safety, supporting businesses though compliance, fostering innovation and promoting growth through domestic and international trade. The association also requested that the UKCR be preserved along with its high standards. While the CTPA does not support the inclusion of the UKCR within the proposed horizontal framework, the association aligns with the efforts by OPSS to improve and future-proof regulation for consumer goods.
The UK cosmetics industry should be able to leverage the use of new technologies and scientific advancements, which may present the opportunity to make a significant contribution to society, including in the way in which consumers interact with daily and essential products.
A report from the PSR consultation is expected shortly.
CTPA Industry Manifesto
The year 2024 will be an important year for high profile elections around the world, including at the European Commission and EU Parliament, in the U.S. and the UK. In relation, the CTPA board has endorsed the association, increasing its advocacy work across the UK political spectrum. This is to suggest a range of policies to the main political parties that will help the industry to grow sustainably, highlight the essentiality of the industry and its products, and raise the visibility of the CTPA, promoting the industry as an important employer offering diverse skills and equal opportunities to all.
As we anticipate the next UK general election, the CTPA has developed its first manifesto for the industry to voice the key asks of the industry while highlighting the important role we play in the daily lives of British citizens. The manifesto was used for a range of other stakeholder meetings in the autumn of 2023 and will officially be published in 2024 when the date of the UK general election is announced.
The year 2024 looks like another hectic one, with plenty of issues to keep the CTPA and cosmetics industry busy.
References
1. Meredith, E., (2023). Fragrance Allergens, Siloxanes, Microplastics and More. Cosmetics & Toiletries. Available at https://www.cosmeticsandtoiletries.com/magazine/article/22873850/cosmetics-toiletries-magazine-fragrance-allergens-siloxanes-microplastics-and-more
2. CTPA, (2021). Reach and Other Horizontal Legislation. CTPA. Available at https://www.ctpa.org.uk/reach
3. UK Department for Food and Rural Affairs (Defra), (2023). UK REACH Alternative Transitional Registration model (ATRm). Available at: https://www.gov.uk/government/publications/uk-reach-alternative-transitional-registration-model-atrm/uk-reach-alternative-transitional-registration-model-atrm
4. UK Government, (2023). Management of CMR Substances under the UK Cosmetics Regulation. Available at: https://www.gov.uk/government/publications/cosmetic-products-exemption-process-for-cmr-substances/management-of-cmr-substances-under-the-uk-cosmetics-regulation
5. UK Department for Business and Trade (DBT), (2023). Smarter Regulation: UK Product Safety Review. Available at: https://www.gov.uk/government/consultations/smarter-regulation-uk-product-safety-review
6. Cosmetic, Toiletry and Perfumery Association (CTPA). (2023). CTPA response to UK Government Product Safety Review. Available at: https://www.ctpa.org.uk/file.php?fileid=4478
