As they apply to cosmetic products being supplied in or ...

1 1 Office for Product Safety & Standards Regulation 2009 /1223 and the cosmetic products Enforcement Regulations 2013 As they apply to cosmetic products being supplied in or into Great Britain from 1 January 2021 Guidance January 2021 cosmetic products Enforcement Regulations 2013: Guidance (GB) Contents INTRODUCTION ..4 Main changes to THE CHAPTER I SCOPE AND Article 1 Scope and Article 2 Definitions ..7 CHAPTER II SAFETY, RESPONSIBILITY & FREE Article 3 Article 4 Responsible Article 5 Obligations of Responsible Persons ..11 Article 6 Obligations of Article 7 Identification within the Supply Chain.

2 12 Article 8 Good Manufacturing CHAPTER III SAFETY ASSESSMENT, PRODUCT INFORMATION FILE, NOTIFICATION ..13 Article 10 & Annex I Safety Part A cosmetic Product Safety Part B cosmetic Product Safety Assessment ..13 Article 10 (2) The Safety Assessor ..14 Article 11 Product Information Article 12 Sampling and Article 13 Notification ..15 CHAPTER IV RESTRICTIONS FOR CERTAIN SUBSTANCES ..17 Article 14 Restrictions for Substances Listed in the Annexes ..17 Article 15 Substances Classified as carcinogenic, mutagenic, or toxic for reproduction (CMR substances) ..17 Article 16 Notification of Nanomaterials ..17 Article 17 Traces of Prohibited Substances ..18 CHAPTER V ANIMAL Article 18 Animal Testing ..19 CHAPTER VI CONSUMER Article 19 Article 19 (1)(a) Name and Article 19 (1)(a) Country of Origin ..20 Article 19 (1)(a) transitional Article 19 (1)(b) Statement of Article 19 (1)(c) Minimum date of durability (Best Before Date).

3 21 Article 19 (1)(c) Period After Opening (PAO)..22 Article 19 (1) (d) Warning Statements and Precautionary Article 19 (1) (e) Batch Number ..23 Article 19 (1) (f) Product Function ..23 Article 19 (1) (g) List of Article 19 (2) Labelling Article 20 Product Article 20 (3) Reference to Animal Testing ..27 Article 21 Public CHAPTER VII MARKET 2 cosmetic products Enforcement Regulations 2013: Guidance (GB) Article 22 In Market Control ..29 Article 23 Communication of Serious Undesirable Article 24 Information on Substances ..29 CHAPTER VIII NON COMPLIANCE, SAFEGUARD Article 25 Non compliance by the Responsible Article 26 Non Compliance by Article 27 Safeguard Clause ..30 Article 28 Good Administrative CHAPTER IX POWERS AND FURTHER DUTIES OF THE SECRETARY OF STATE.

4 31 Article 30 Power to amend Articles ..31 Article 31 Power to amend the annexes ..31 Article 32 Procedures for making regulations ..31 APPENDIX 1 ..32 Identification of Unlisted Ingredients ..32 APPENDIX 2 ..33 Ingredient labelling example ..33 APPENDIX 3 ..34 Symbols used on Packaging / Container from Annex VII of the Cosmetics APPENDIX 4 ..35 Illustrative list of cosmetics (Recital 7 to the Regulation): ..35 APPENDIX 5 ..36 APPENDIX 6 ..38 Useful links ..38 APPENDIX 7 ..39 3 cosmetic products Enforcement Regulations 2013: Guidance (GB) Introduction 1. This Guide is for businesses placing cosmetics products on the market in Great Britain (GB). Great Britain is England, Scotland and Wales.

5 If you are placing cosmetic products on the market in Northern Ireland, you should read the separate guidance for placing cosmetic products on the market in Northern Ireland. This guide is designed to help you understand Regulation (EC) no 1223 / 2009 on cosmetic products , as amended by the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019. The Regulation sets out requirements that must be met before cosmetics products can be placed on the GB market. The purpose of the Regulation is to safeguard public health and establish a fully competitive market. Main changes to Regulations 2. The main changes to note that will take effect from the end of the Transition Period on 31 December 2020 are: Placing on the market: the term placing on the market means the first making available of a product on the market of Great Britain after the end of the transition period.

6 Making available refers to supply on the GB market; [Article 2] Responsible Person: There must be a Responsible Person based in the UK under the new regime; [Articles 4, 5 and 5A] Product Information File: An up to date Product Information File (PIF) must be maintained in English, and made available to market surveillance and enforcement authorities at the UK address provided when asked to do so; [Article 11] Labelling: There will be a 2-year transition period from 1 January 2021 before businesses have to include the UK Responsible Person details on product labels, provided the EU responsible person details are included. This will enable existing stocks to make their way through the supply chain and reflects the typical shelf-life of a cosmetic and business labelling cycles; [Article 19] UK Submit cosmetic Product Notification (SCPN) service: The UK Government has established a cosmetic product notification service to replace the EU s Cosmetics products Notification Portal (the CPNP ) in Great Britain; [Article 13] Notification of cosmetic products to Secretary of State (via UK SCPN service): o UK Responsible Persons will need to notify existing products (previously available in the UK, EU or EEA and notified to CPNP) by 31 March 2021 to the Secretary of State via the UK SCPN service if they are placing them on the GB market after the end of the transition period.

7 There is a reduced amount of information required where this is the case and you can use the same information you have previously provided to the EU CPNP service. o For products that have not previously been notified to the Commission via the CPNP or have not been placed on the EEA market, or are placed on the GB market after 31 December 2020, UK Responsible Persons will need to provide full information to the Secretary of State via the UK SCPN service before they can be placed on the market. [Article 13] 4 cosmetic products Enforcement Regulations 2013: Guidance (GB) Serious Undesirable Effects (SUEs) : SUEs should be notified on the new UK SUE form. I nformation on any SUE should be notified to OPSS at [Article 23] products with nanomaterials: Where the inclusion in a cosmetic product of relevant nanomaterials has not been notified to the Commission prior to the end of the transition period on 31 December 2020, a cosmetic product containing novel nanomaterials not used for the purposes of colourant, preservative, or UV-filter must be notified to the Secretary of State, via the UK s Submit cosmetic Product Notification Portal by the Responsible Person 6 months prior to it being placed on the GB market; [Article 16] Importers: From 1 January 2021 UK Businesses who bring cosmetic products into GB from an EU Member State will become importers where they would previously have been distributors.

8 The importer of a cosmetic product, whether from the EU or another country, becomes a Responsible Person by default, although they may appoint an agent to act as the Responsible Person for them. There are particular provisions for Northern Ireland businesses who place products from countries outside of the UK (including the EEA) on the market in Great Britain; [Articles 2 and 4] Unfettered access: The government has committed to deliver unfettered access for qualifying Northern Ireland goods to the rest of the UK market. cosmetic products that are placed on the market in Northern Ireland (in accordance with the European Union Regulation (EC) no 1223 / 2009 on cosmetic products , as it applies in Northern Ireland) can be sold in the rest of the UK with no additional approvals. To protect consumers across the UK, Northern Ireland businesses who are Responsible Persons, must notify the GB regulator via the UK Submit cosmetic Product Notification (SCPN) service with the cosmetics ingredients and alert the GB regulator if their product is found to be unsafe.

9 This will not require any new information to be collated: only that the same information provided to the EU via the CPNP service is also provided to the Secretary of State. This only applies to products that are placed on the GB market after the transition period. This approach applies to qualifying Northern Ireland goods. Further detail is available in Appendix 7. To Note: for cosmetic products also contained in aerosol dispensers, the aerosol dispensers will need to meet the requirements of the Aerosol Dispensers Regulations 2009 , which includes the requirement to mark the dispenser with UKCA compliance mark, which is replacing the reversed epsilon mark. There is dual recognition of the reversed epsilon ( 3 ), until 31 December 2021. The switch to the UKCA marking is compulsory from 1 January 2022. Until 31 December 2022, the UKCA marking may be affixed to a label affixed to or a document accompanying the dispenser.

10 5 cosmetic products Enforcement Regulations 2013: Guidance (GB) The Regulation Introduction 3 The Regulation (EC) no 1223 / 2009 on cosmetic products as amended by the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (hereafter the Regulation ) is grouped into 9 main subject Chapters. 4 This guide seeks to provide practical advice with respect to the Regulation as it applies in Great Britain. If you require further advice or information, you should contact the Trading Standards department of your Local Authority or Unitary Authority. 6 cosmetic products Enforcement Regulations 2013: Guidance (GB) Chapter I Scope and Definitions Article 1 Scope and Objective 5 The Regulation applies to all cosmetic products made available on the GB market.