legislation-profile

Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products

Scope

Establishes rules for all cosmetic products made available on the market, in order to ensure the functioning of the internal market and the safety of cosmetic products leading to a high level of protection of human health. In accordance with Art. 2, a 'cosmetic product' means ''any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours''.

Exemptions

Not specified

Regulatory activities

1. Safety assessment (Art.10) 2. Product Information File (Art. 11) When a cosmetic product is placed on the market, the responsible person shall keep a product information file for it. The product information file shall be kept for a period of ten years following the date on which the last batch of the cosmetic product was placed on the market. 3. Notification (Art.13) Prior to placing the cosmetic product on the market, the responsible person shall submit, by electronic means, the information as defined in the Article 13. 4. Restrictions (Art.14) (a) Prohibited substances - listed in Annex II; CMR of category 2 as per Article 15 (b) Restricted substances-substances which are not used in accordance with a type of restrictions as defined in Annex III: b1: Restrictionsbased on product type b2: Maximumconcentration in ready to use preparation b3: Other > General use and professional use-based restrictions Prior to placing a cosmetic product on the market, the responsible person (Art. 4) shall ensure that the product has undergone a safety assessment and that a cosmetic product safety report is set up in accordance with Annex I.

Relevant product types

Yes Reference list of cosmetic products Reference list of 'body parts'

Reference documents

Yes Annex IV, for purity criteria reference to Commission Directive 95/45/EC of 26 July 1995 laying down specific purity criteria concerning colours for use in foodstuffs

Obligations based on CLP hazard class

Not specified

Obligations based on properties of concerns

Yes (Art. 15) Article 15: Substances classified as CMRs Description: Under Article 15 CMRs classified as category 1A, 1B and 2 under the CLP Regulation are prohibited for use in cosmetic products. There are exemptions for this under Article 15(2). CMR category 2 substance may be used in cosmetic products where the substance has been evaluated by the Scientific Committee on the Consumer Safety (SCCS).

EU-level occupational exposure limits

Not specified

EU-level emission limit values

No provision

Substance-centric data source(s) at the EU level

Yes Cosmetic Ingredient Database ('CosIng') Description: 'CosIng' is the European Commission database for information on cosmetic substances and ingredients. Link to 'CosIng' CosIng has been developed back in 2008 on a voluntary basis by the Commission at the time of the repealed Directive; the initiative started from a policy officer who had a list of ingredients in MS Access. The development project lasted for a year. Afterwards, CosIng was further improved. The database content is published on Europa and contains the inventory of ingredients and the lists of substances that are regulated (Annexes II, III, IV, V, VI). The main sets of data are as well available from the EU Open Data portal.

Industry submission system in place

Yes Cosmetic Product Notification Portal (CPNP)

Format for industry submission

Yes

Owner

DG GROW

Update process

The Commission may after consulting Scientific Committee on Consumer Safety (SCCS) amend Annexes I-VI and VIII. (Art. 31) The Commission shall compile and maintain glossary of common ingredient names. (Art. 32)

Amendments

Commission Regulation (EU) No 344/2013 amending Annexes II, III, V and VI to Regulation (EC) No 1223/2009- Annex II to Regulation (EC) No 1223/2009 is amended Commission Regulation (EU) No 344/2013 amending Annexes II, III, V and VI to Regulation (EC) No 1223/2009- Annex III to Regulation (EC) No 1223/2009 is amended Commission Regulation (EU) No 344/2013 amending Annexes II, III, V and VI to Regulation (EC) No 1223/2009 - Annex V to Regulation (EC) No 1223/2009 is amended Commission Regulation (EU) No 344/2013 amending Annexes II, III, V and VI to Regulation (EC) No 1223/2009 - Annex VI to Regulation (EC) No 1223/2009 is amended Corrigendum to Commission Regulation (EU) No 344/2013 amending Annexes II, III, V and VI to Regulation (EC) No 1223/2009- Annex II to Regulation (EC) No 1223/2009 is amended Corrigendum to Commission Regulation (EU) No 344/2013 amending Annexes II, III, V and VI to Regulation (EC) No 1223/2009- Annex III to Regulation (EC) No 1223/2009 is amended Corrigendum to Commission Regulation (EU) No 344/2013 amending Annexes II, III, V and VI to Regulation (EC) No 1223/2009 - Annex V to Regulation (EC) No 1223/2009 is amended Corrigendum to Commission Regulation (EU) No 344/2013 amending Annexes II, III, V and VI to Regulation (EC) No 1223/2009 - Annex VI to Regulation (EC) No 1223/2009 is amended Commission Regulation (EU) No 483/2013 amending Annex III to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products - an entry is added Commission Regulation (EU) No 658/2013 amending Annexes II and III to Regulation (EC) No 1223/2009 - Annex II, an entry is added Commission Regulation (EU) No 658/2013 amending Annexes II and III to Regulation (EC) No 1223/2009 - Annex III is amended Commission Regulation (EU) No 1197/2013 amending Annex III to Regulation (EC) No 1223/2009 - Annex III to Regulation (EC) No 1223/2009 is amended (entries 12, 22, 203,217,229, 241, 242, 244 and 245 are replaced Commission Regulation (EU) No 358/2014 amending Annexes II and V to Regulation (EC) No 1223/2009 - Annex II the entries 1374 to 1378 are added Commission Regulation (EU) No 358/2014 amending Annexes II and V to Regulation (EC) No 1223/2009 - Annex V is amended (entry 12, 25 are replaced) Commission Regulation (EU) No 866/2014 of amending Annexes III, V and VI to Regulation (EC) No 1223/2009 - In Annex III, the entries 265 and 266 are added Commission Regulation (EU) No 866/2014 amending Annexes III, V and VI to Regulation (EC) No 1223/2009 - Annex V is amended Commission Regulation (EU) No 866/2014 amending Annexes III, V and VI to Regulation (EC) No 1223/2009 - In Annex VI entry 29 is added Corrigendum to Commission Regulation (EU) No 866/2014 amending Annexes III, V and VI to Regulation (EC) No 1223/2009- In Annex III, the entries 286 and 287 are added Corrigendum to Commission Regulation (EU) No 866/2014 amending Annexes III, V and VI to Regulation (EC) No 1223/2009 - Annex V is amended, entry 44 is replaced, entry 59 is added Corrigendum to Commission Regulation (EU) No 866/2014 amending Annexes III, V and VI to Regulation (EC) No 1223/2009 - In Annex VI entry 29 is added Commission Regulation (EU) No 1003/2014 amending Annex V to Regulation (EC) No 1223/2009 - Entries 39 and 57 of Annex V to Regulation (EC) No 1223/2009 on cosmetic products are replaced Commission Regulation (EU) No 1004/2014 amending Annex V to Regulation (EC) No 1223/2009 - Annex V to Regulation (EC) No 1223/2009 is amended, entry 12 is replaced Commission Regulation (EU) 2015/1190 amending Annex III to Regulation (EC) No 1223/2009 - Annex III to Regulation (EC) No 1223/2009 is amended Commission Regulation (EU) 2015/1298 amending Annexes II and VI to Regulation (EC) No 1223/2009 - Annex II, an entry is added, in Annex VI the entry concerning reference number 19 is deleted Commission Regulation (EU) 2016/314 amending Annex III to Regulation (EC) No 1223/2009 - In Annex III to Regulation (EC) No 1223/2009, an entry is added Corrigendum to Commission Regulation (EU) 2016/314 amending Annex III to Regulation (EC) No 1223/2009 - Annex V to Regulation (EC) No 1223/2009, entry 57 is replaced Commission Regulation (EU) 2016/621 amending Annex VI to Regulation (EC) No 1223/2009 - Addition to Annex VI to Regulation (EC) No 1223/2009 Commission Regulation (EU) 2016/622 amending Annex III to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products Commission Regulation (EU) 2016/1120 amending Annex IV to Regulation (EC) No 1223/2009 - Annex IV to Regulation (EC) No 1223/2009 is amended Commission Regulation (EU) 2016/1121 amending Annex V to Regulation (EC) No 1223/2009 - Entry 58 of Annex V to Regulation (EC) No 1223/2009 is replaced Commission Regulation (EU) 2016/1143 amending Annex VI to Regulation (EC) No 1223/2009 - Annex VI to Regulation (EC) No 1223/2009 is amended Commission Regulation (EU) 2016/1198 amending Annex V to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products Commission Regulation (EU) 2017/237 amending Annex III to Regulation (EC) No 1223/2009 - Annex III to Regulation (EC) No 1223/2009, entries 298 to 305 are added (additional the entries 200, 206, 211, 243 and 272 are replaced, entry is inserted as a reference number 9b, the entry 9a is replaced, entry is inserted as reference number 8c) Commission Regulation (EU) 2017/238 amending Annex VI to Regulation (EC) No 1223/2009 - In Annex VI to Regulation (EC) No 1223/2009, entry 4 is replaced Commission Regulation (EU) 2017/1224 amending Annex V to Regulation (EC) No 1223/2009 - In Annex V to Regulation (EC) No 1223/2009, entry 57 is replaced Commission Regulation (EU) 2017/1410 amending Annexes II and III to Regulation (EC) No 1223/2009 - in Annex II, in the table, three entries are added Commission Regulation (EU) 2017/1410 amending Annexes II and III to Regulation (EC) No 1223/2009 - in Annex III, in the table, entry 79 is deleted Commission Regulation (EU) 2017/1413 amending Annex IV to Regulation (EC) No 1223/2009 - Entry 144 of Annex IV to Regulation (EC) No 1223/2009 is replaced Commission Regulation (EU) 2017/2228 amending Annex III to Regulation (EC) No 1223/2009 - In Annex III to Regulation (EC) No 1223/2009, two entries are added Corrigendum to Commission Regulation (EU) 2017/2228 amending Annex III to Regulation (EC) No 1223/2009 - In Annex III to Regulation (EC) No 1223/2009,two entries are added Commission Regulation (EU) 2018/885 amending Annex VI to Regulation (EC) No 1223/2009 - In Annex VI, entry 23 is replaced and entry 23a is inserted Commission Regulation (EU) 2018/978 amending Annexes II and III to Regulation (EC) No 1223/2009 - in Annex II, in the table, 1 entry is added, and in Annex III, in the table, 2 entries are added Corrigendum to Commission Regulation (EU) 2018/978 amending Annexes II and III to Regulation (EC) No 1223/2009 - in Annex II, in the table, 1 entry is added, and in Annex III, in the table, 2 entries are added Commission Regulation (EU) 2018/1847 of 26 November 2018 amending Annex V to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products Commission Regulation (EU) 2019/680 amending Annex VI to Regulation (EC) No 1223/2009 - in Annex VI, entry 31 is added Commission Regulation (EU) 2019/681 amending Annex II to Regulation (EC) No 1223/2009 - in Annex II, entry 1384 is added Commission Regulation (EU) 2019/698 amending Annexes III and V to Regulation (EC) No 1223/2009 - in Annex III, entry 310 is added, and in Annex V, entry 32 is amended Commission Regulation (EU) 2019/831 amending Annexes II, III and V to Regulation (EC) No 1223/2009 - in Annex II, entries 1385-1611 are added, and entry 395 is replaced; in Annex III, entries 1a, 1b, 7, 13 and 51 are deleted, entry 12 is replaced, and entries 311, 312 are added; and in Annex V, entries 5, 31, 40 and 41 are deleted, and entry 28 is replaced Commission Regulation (EU) 2019/1257 of 23 July 2019 correcting the Bulgarian language version of Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products Commission Regulation (EU) 2019/1857 of 6 November 2019 amending Annex VI to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products

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