SCS FORMULATE 2021
Post-Brexit chemical safety: SAG-CS and UK REACH now in place for ingredient management
Commissioned by the Office for Product Safety and Standards (OPSS), SAG-CS had been formed earlier this year to monitor chemical safety of products on the UK market; mirroring the work previously conducted by the European Commission’s Scientific Committee for Consumer Safety (SCCS) when the UK formed part of the EU. The mission of SAG-CS was “to provide OPSS with scientific advice and risk assessment in the areas of public health and consumer safety” across three categories: cosmetic products and cosmetic ingredients; toys; and textiles.
So, were there any cosmetic chemicals up for discussion in the first year of SAG-CS? And should cosmetic manufacturers be concerned about any specific ingredients?
‘Its main focus is toys’ for now, but processes must be clarified
Dr. Emma Meredith, director-general of the Cosmetic, Toiletry and Perfumery Association (CTPA), said that, for now, nothing on cosmetics or cosmetic ingredients had been raised.
Addressing attendees at SCS Formulate 2021’s first day of ‘inform’ sessions in Coventry, UK, Meredith said: “Currently, it’s not looking at cosmetic ingredients; its main focus is toys.”
After SAG-CS’s first two meetings – one in July and a second in September – the advisory group had already published two UK mandates on chemicals in toys, one on formaldehyde in toy materials and another on aluminium in toys or components of toys.
Set to meet six times per year, Meredith said over the next 12 months the group was scheduled to continue its focus on toy safety rather than cosmetics. However, she said the full process of SAG-CS and subsequent regulatory impacts remained unclear.
“We now have a process for ingredient management that mirrors the EU. If an issue is raised, the SAG-CS will be asked to review. Beyond that, OPSS has still not clarified what that process is. CTPA is in constant dialogue with OPSS to ensure we have clarity for industry on this important process as soon as possible,” she said.
‘Divergence’ between UK and EU restricted or prohibited chemicals
Meredith said that since January 2021, any chemical reviewed by the EU’s SCCS or chemical legislation adopted in the EU market was no longer automatically adopted in the UK, as had been the case prior to this date.
Up until January this year, the UK had fully onboarded the EU’s restricted and prohibited chemicals list, for example, but since this date some new legislation had passed in the EU, including classifications of carcinogenic, mutagenic or toxic for reproduction (CMR) chemicals under the EU’s third and fourth Omnibus, she said. Earlier this month, the European Commission detailed its fourth Omnibus update, adding 23 CMR chemicals to its prohibited substances list under Article 15 of the EU Cosmetics Regulation 1223/2009, including zinc Pyrithione. Bans on these chemicals would be in place for any cosmetic product placed on the EU market from March 1, 2022.
“In the EU, our ingredients are under constant review (…) So we’re already seeing a little bit of divergence between the EU and UK,” Meredith said.
The UK’s REACH legislation also differed to the EU version, she said, with a sharp focus and responsibility placed on downstream users.
UK REACH has a ‘massive impact’ on downstream chemical users
“For CTPA and all involved in the industry, it became apparent that UK REACH would have a massive impact for our industry, not just for the perspective of availability and problems in the supply chain but because as an industry we are downstream users,” Meredith said.
Implemented in January 2021, the UK REACH regulation placed a “huge level of responsibility” on downstream users of ingredients that was “not there before”, she said. Whilst under EU REACH, the movement of ingredients had been simple given the high level of involvement and responsibility taken by suppliers, now, UK cosmetic manufacturers sourcing ingredients from the EU were responsible for compliance with the UK chemicals legislation.
“For a lot of companies, the UK REACH has been a very massive and steep learning curve which is still ongoing. The key principles are ECHA-based, hazard-based legislation – if you have no data to support the safe use, you cannot market that chemical. But the burden of proof is on companies to identify and manage the risks linked to the substances. Then you need to demonstrate how the substance can be safely used and communicate the risk management measures to the users.”
To ease this new pressure on cosmetic manufacturers, Meredith said the CTPA had “fought really strongly” to ensure all legal requirements under UK REACH were introduced in a phased approach, giving companies two, four or six years to fulfil regulatory obligations depending on hazard. This phased approach, she said, had started from October 28, this year.
D5, D6 and microplastics not a short-term UK REACH focus
Looking forward at the remainder of 2021 and 2022, Meredith said that, unlike its EU counterpart, UK REACH would not be focused on D5, D6 and microplastics, though regulatory management option analysis (RMOAs) were expected for those ingredients “some time in the future”. Instead, UK REACH would be focused on Perfluoroalkyl and Polyfluoroalkyl Substances (PFAs), she said.
“PFAs is a priority and already undergoing an RMOA,” she said. And whilst this group of chemicals was vast, it wasn’t widely used in cosmetics nor would industry defend their use in cosmetics, she said. The CTPA was, however, concerned that should UK REACH regulate PFAs, it might “set a precedent” on regulating groups of chemicals rather than individual chemicals, she said. “Yes, there are a certain amount of PFAs with environmental concerns, but you should look at the individual ingredient.”