Figure 2 – Effects of Northern Ireland protocol
‣ These include Carcinognic , Mutagenic & Reprotoxic ( CMR ) Omnibuses III and IV , which affected several cosmetic ingredients . Under the former , titanium dioxide and salicylic have been classified as CMR 2 substances . The latter listed sodium hydroxymethylglycinate ( SHMG ), zinc pyrithione & BMHCA ( known by the trade name Lilial ), which have all been classified as CMR 1B substances and are unlikely to be defended ; implementation comes into force in the EU in March 2022 . The ability to diverge in the UK is not necessarily a bad thing in all cases from the CTPA ’ s point of view . The critical thing for us as an industry , certainly in the UK , is to be able to promote riskbased legislation and to be dataand science-led . A good example of where divergence can be positive is with dihydroxyacetone ( DHA ), which has a positive SCCS opinion for use in self-tanning at levels of up to 10 % and is also finding new uses as a hair dye . We believe that the data support a higher concentration and CTPA has set up a consortium to support this in the UK . There is also divergence on methyl-N-methylanthranilate , a fragrance , and also on D5 and D6 in leave-on cosmetics . The latter are under review under the REACH Regulation , not the CPR .
UK REACH for cosmetics
UK REACH , which also came into effect on 1 January 2021 , was always going to have a big impact on cosmetics , partly because of how it will affect the supply and availability of chemicals and more generally because this is mainly an industry of downstream users ( DSUs ), who now have extra roles and responsibilities under UK REACH . Now , a company importing a chemical from , say , Germany , has new obligations under UK REACH . This has been a steep learning curve for some companies . The key principles and obligations of UK REACH are essentially the same as EU REACH ( Figure 2 ):
• No data , no market : companies must be able to prove the chemicals they market are safe and the burden of proof is on them
• Demonstrating to the competent authority , the Health & Safety Executive ( HSE ), how the substance can be safely used , with the possibility of restrictions , bans or substitutions if the HSE is not satisfied
• Identifying and managing the risks linked to the substances they manufacture and market in GB
• Communicating the risk management measures to the users Like EU REACH , UK REACH covers substances manufactured or imported at > 1 tonne / year by each legal entity . It affects ‘ substances on their own ’, such as cosmetic ingredients manufactured or imported as raw materials ; and ‘ substances within mixtures ’, such as cosmetic ingredients that make up a finished cosmetic product . Additional obligations for DSUs under UK REACH included the requirement for registration holders to provide top-line information on products within 120 days of UK REACH coming into force . For DSUs , a downstream user import notification ( DUIN ) had to be submitted by 28 October 2021 . CTPA and other chemicals trade bodies successfully argued for a phased approach to implementation , just as there had been under EU REACH , and there are now two- , four- and six-year deadlines for registration under UK REACH . These depend on the tonnage and hazard of the ingredients . Key continuing obligations on DSUs are to :
• Identify the identity and quantity of all the cosmetic ingredients within their portfolio
• Collaborate with suppliers to understand their plans to comply with UK REACH
• If based in the Republic of Ireland , appoint a UK-based entity or Only Representative
• Keep proof of DSU status pre-Brexit
54 SPECIALITY CHEMICALS MAGAZINE ESTABLISHED 1981