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.

2 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 ..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.

3 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)..21 Article 19 (1)(c) Period After Opening (PAO).

4 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.

5 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. 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.

6 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. 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.

7 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.

8 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.

9 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.

10 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.