CHEMICALS BANNED OR RESTRICTED FOR USE IN COSMETICS

CHEMICALS BANNED OR RESTRICTED FOR USE IN COSMETICS UNDER EU LAW Presented by: Dr John Stewart, Regulatory Specialist UL Product Supply Chain Intelligence UL and the UL logo are trademarks of UL LLC © 2017. Proprietary & Confidential. 1

INTRODUCTION § Suppliers that place cosmetic products on the EU market are required to comply with a range of EU legislation. § Control measures implemented through EU legislation, that are intended to make cosmetics safer, may impact a products ability to go to market. § BUSINESS RISK! - Companies need to monitor these regulations on an ongoing basis for any changes that may affect their business. § One key control measure involves the banning and restricting of chemicals for use in cosmetic products. UL and the UL logo are trademarks of UL LLC © 2017. Proprietary & Confidential.

AGENDA § EU Legislation – impact on cosmetics? § Regulatory control measures § Recently banned and restricted chemicals § Q & A UL and the UL logo are trademarks of UL LLC © 2017. Proprietary & Confidential.

EU LEGISLATION Cosmetics products (either raw materials or finished products) are impacted by the following EU Legislation: § Cosmetics Regulation (EC) No 1223/2009 § REACH Regulation (EC) No 1907/2006 § CLP Regulation (EC) No 1272/2008 UL and the UL logo are trademarks of UL LLC © 2017. Proprietary & Confidential.

COSMETIC REGULATION § Regulation (EC) N° 1223/2009 is the main regulatory framework for finished cosmetic products placed on the EU market. § Came into force in July 2013. § Replaced Directive 76/768/EC, which was previously adopted in 1976. UL and the UL logo are trademarks of UL LLC © 2017. Proprietary & Confidential.

COSMETIC REGULATION § Legislation designed to improve the safety of cosmetic products and streamline framework for all operators in the sector. § Includes a series of Annexes (II – VI) that lists authorised, restricted and banned substances for use in cosmetics. UL and the UL logo are trademarks of UL LLC © 2017. Proprietary & Confidential.

ANNEXES II-VI PROHIBITIONS RESTRICTIONS Annex III Annex IV LIST OF SUBSTANCES WHICH COSMETIC PRODUCTS MUST NOT CONTAIN EXCEPT SUBJECT TO THE RESTRICTIONS LAID DOWN LIST OF COLORANTS ALLOWED IN COSMETIC PRODUCTS LIST OF SUBSTANCES PROHIBITED IN COSMETIC PRODUCTS UL and the UL logo are trademarks of UL LLC © 2017. Proprietary & Confidential. AUTHORISATIONS Annex V LIST OF PRESERVATIVES ALLOWED IN COSMETIC PRODUCTS Annex VI LIST OF UV FILTERS ALLOWED IN COSMETIC PRODUCTS 8

AMENDMENTS TO COSMETIC REGULATION § New authorisations, prohibitions and restrictions of chemicals are introduced into the Cosmetic Regulations through the release of amendments. § At present, 26 amendments to the cosmetic regulations have been published including corrigendum, technical documents, guidance and claims. UL and the UL logo are trademarks of UL LLC © 2017. Proprietary & Confidential. 9

RECENTLY PUBLISHED AMENDMENTS The following amendments were recently published in 2017: Amendment Annex amended Regulation (EU) 2017/237 Regulation (EU) 2017/238 Regulation (EU) 2017/1224 Regulation (EU) 2017/1410 Regulation (EU) 2017/1413 Regulation (EU) 2017/2228 Annex III Annex V Annex II and III Annex IV Annex III UL and the UL logo are trademarks of UL LLC © 2017. Proprietary & Confidential. 10

AMENDMENTS TO ANNEX III Hydrolysed wheat protein Peanut oil, its extracts and derivatives RESTRICTIONS Maximum molecular weight average of 3. 5 k. Da. Effective from 25 September 2018. UL and the UL logo are trademarks of UL LLC © 2017. Proprietary & Confidential. Maximum allowable concentrations of 0. 5 ppm. 12

AMENDMENTS TO ANNEX IV - COLORANTS AUTHORISATIONS Zinc oxide § Authorised as a colorant in cosmetics in Annex IV. § Safe when used, in its uncoated non-nano form, in cosmetics for dermal application. § Restricted to applications which don’t lead to exposure of the lungs by inhalation. Effective from 24 February 2018. UL and the UL logo are trademarks of UL LLC © 2017. Proprietary & Confidential. 13

AMENDMENTS TO ANNEX V - PRESERVATIVES AUTHORISATIONS Methylisothiazolinone § Authorised as a preservative in rinse-off cosmetic products. § Previous authorisation restricted concentration of MIT up to 0. 01%. § Maximum allowable concentration reduced to 0. 0015%. Effective from 27 January 2018. UL and the UL logo are trademarks of UL LLC © 2017. Proprietary & Confidential. 14

AMENDMENTS TO ANNEX VI – UV FILTERS AUTHORISATIONS Benzophenone-3 § Authorisation for the use of Benzophenone-3 as a UV-filter at a maximum concentration of up to 10% w/w in cosmetic products, has been decreased to 6% w/w. Effective from 3 September 2017. UL and the UL logo are trademarks of UL LLC © 2017. Proprietary & Confidential. 15

REACH (EC) NO 1907/2006 § Legally came in to force in 2007. § Gradual implementation over following years. § Aim to harmonise standards of manufacturing, supply and safe use of chemicals across EEA. § Chemical raw materials and finished cosmetics products are impacted by REACH. § Key control measures: § Registration, restriction and authorisation UL and the UL logo are trademarks of UL LLC © 2017. Proprietary & Confidential. 17

REACH RESTRICTION § Instrument to protect human health and the environment from unacceptable risks posed by chemicals. § Used to limit or ban the manufacture, placing on the market (including imports) or use of a substance. § Can impose any relevant condition, such as requiring technical measures or specific labels. § May apply to any substance on its own, in a mixture (e. g. cosmetic) or in an article. § Companies need to monitor restriction processes that may impact their business. UL and the UL logo are trademarks of UL LLC © 2017. Proprietary & Confidential. 18

RESTRICTION PROCESS Intention to restrict Registry of intention Restriction dossier Public consultation Decision Enforcement UL and the UL logo are trademarks of UL LLC © 2017. Proprietary & Confidential. 19

RESTRICTION PROCESS Member State/ ECHA Commission Intention to restrict Further investigation UL and the

RESTRICTION PROCESS Requirement to notify. Registry of Intentions (Ro. I). Registry of intention ECHA website. UL and the UL logo are trademarks of UL LLC © 2017. Proprietary & Confidential. Publicly available. Interested parties. 21

RESTRICTION PROCESS Interested parties can comment within six months. Dossier made publicly available. Public consultation ECHA’s Committees provide opinions. Risk Assessment Committee. 9 months. UL and the UL logo are trademarks of UL LLC © 2017. Proprietary & Confidential. Socio-Economic Analysis Committee. 23

RESTRICTION PROCESS ECHA’s committees’ opinions contribute to decision. Decision Within three months, draft amendment to the list of restrictions in Annex XVII to REACH is prepared. UL and the UL logo are trademarks of UL LLC © 2017. Proprietary & Confidential. Final decision. Comitology procedure. 24

RESTRICTION PROCESS Manufacturers, importers, distributors, downstream users and retailers. Once the restriction has been adopted, industry must comply. Enforcement Member States enforce restriction. UL and the UL logo are trademarks of UL LLC © 2017. Proprietary & Confidential. 25

REACH RESTRICTIONS - UPDATE Decamethylcyclopentasiloxane (D 5) Octamethylcyclotetrasiloxane (D 4) § Used in deodorants, sun blocks, § Used in antiperspirants, deodorants, hair sprays, skin care products, skin creams, lotions, bath oils, suntan hair conditioners. and shaving products. UL and the UL logo are trademarks of UL LLC © 2017. Proprietary & Confidential. 26

RESTRICTION § In January 2018, both D 4 and D 5 were added to ECHA’s restricted substances list (Annex XVII of REACH). § Can no longer be placed on the market in wash-off cosmetic products (shampoos, conditioners etc. ) in a concentration equal to or greater than 0. 1% after January 31 st 2020. UL and the UL logo are trademarks of UL LLC © 2017. Proprietary & Confidential. 27

WHY ARE THESE INGREDIENTS RESTRICTED? D 4 § Toxic to human reproduction system. § Accumulates in the environment with unpredictable long-term effects. § Harmonised classification (Annex VI, CLP): § § Repr. 2, Aquatic Chronic 4. Persistant, Bioaccumulative and Toxic (PBT). Article 15 of Cosmetic Regulations prohibits use of CMRs. Due to be added to Annex II of Cosmetic Regulations. D 5 § Harmful to the environment. § Very persistant and very bioaccumulative (v. Pv. B). UL and the UL logo are trademarks of UL LLC © 2017. Proprietary & Confidential. 28

POTENTIAL FURTHER RESTRICTIONS § In April 2017 an intention for D 4 and D 5 to be restricted in leave on personal care products and other consumer/professional products (e. g. dry cleaning, waxes and polishes, washing and cleaning products) in concentrations > 0. 1% was submitted. § On 28 February 2018, the following substance was added to this Intentions for Restriction: § Dodecamethylcyclohexasiloxane (D 6) [CAS# 540 -97 -6] UL and the UL logo are trademarks of UL LLC © 2017. Proprietary & Confidential. 29

POTENTIAL FURTHER RESTRICTIONS § Additionally, D 6 is intended to be restricted in wash off cosmetic products in concentrations > 0. 1%. § Annex XV dossier expected to be submitted on 11 January 2019. UL and the UL logo are trademarks of UL LLC © 2017. Proprietary & Confidential. 30

IN SUMMARY § Cosmetic products placed on the EU market are required to comply with a range of EU legislation. § Legislative control measures may impact a products ability to go to market. § Companies need to monitor these regulations on an ongoing basis for any changes that may affect their business. UL and the UL logo are trademarks of UL LLC © 2017. Proprietary & Confidential. 31

THINK! Effective business systems in place to review and monitor: § § Product components and data Supply chain confidence and material traceability Supply chain communication Ongoing regulatory compliance UL and the UL logo are trademarks of UL LLC © 2017. Proprietary & Confidential. 32

DIGITAL SOLUTIONS BACKED BY DATA, SCIENCE AND REGULATORY EXPERTISE. THANK YOU Presented by: Dr John Stewart, Regulatory Specialist UL Product Supply Chain Intelligence Phone: +44 (0)115 965 1888; Email: info-sq@ul. com UL and the UL logo are trademarks of UL LLC © 2017. Proprietary & Confidential. 33