Regulation (EC) No 1223/2009 contains a number of annexes. of 30 November 2009. on cosmetic products (recast) (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof, This directive shall enter into force on the twentieth day following that of its publication in the OJ(i.e. USAN which correspond to the United State approved name; The name in the glossary of common ingredient names referred to in Article 33 of this Regulation. It covers their hazardous properties, classification and labelling, and information on how to use them safely. Amendment to Regulation (EC) No 1223/2009. Dependent on the legislation item being viewed this may include: This timeline shows the different versions taken from EUR-Lex before exit day and during the implementation period as well as any subsequent versions created after the implementation period as a result of changes made by UK legislation. Annex II—List of Substances Prohibited in Cosmetic Products: Under EC No. In Article 2 of Regulation (EC) No 1223/2009, the following paragraph is added: ‘4. The web archive version is the official version of this legislation item as it stood on exit day before being published to legislation.gov.uk and any subsequent UK changes and effects applied. Biocidal Products Committee opinions on active substance approval, National authorisation and mutual recognition, Understanding the Waste Framework Directive, Tools to prepare and submit SCIP notifications, List of substances subject to the POPs Regulation, Draft recommendation for inclusion in the Authorisation List and consultation, Submitted restrictions under consideration, Harmonised classification and labelling targeted consultations, Consultations on ECHA Executive Director’s requests, PACT - Public Activities Coordination Tool, Information on Candidate List substances in articles, Candidate List of substances of very high concern for Authorisation, Registry of restriction intentions until outcome, Registry of SVHC intentions until outcome, Table of harmonised entries in Annex VI to CLP, Occupational exposure limits - Activity list, Harmonised classification and labelling (RAC), (+/-)-2-(2,4-Dichlorophenyl)-3-(1H-1,2,4-triazol-1-yl)propyl-1,1,2,2-Tetrafluoroethylether, (+/-)-Tetrahydrofurfuryl (R)-2-[4-(6-chloroquinoxalin-2-yloxy)phenyloxy]propionate, (1,3,4,5,6,7-Hexahydro-1,3-dioxo-2H-isoindol-2-yl)methyl (1R-trans)-2,2-dimethyl-3-(2-methylprop-1-enyl)cyclopropanecarboxylate, (1R,4S,5R,8S)-1,2,3,4,10,10-Hexachloro-1,4,4a,5,8,8a-hexahydro-1,4:5,8-dimethanonaphthalene, (1R,4S,5R,8S)-1,2,3,4,10,10-Hexachloro-6,7-epoxy-1,4,4a,5,6,7,8, 8a-octahydro-1,4:5,8-dimethano-naphthalene, (2-Acetoxyethyl)trimethylammonium hydroxide, (2-Chloroethyl)(3-hydroxypropyl)ammonium chloride, (2-Ethylhexanoato-O)(isodecanoato-O)nickel, (2-Ethylhexanoato-O)(isononanoato-O)nickel, (2-Ethylhexanoato-O)(neodecanoato-O)nickel, (29H,31H-Phthalocyaninato(2-)-N29,N30,N31,N32)copper, (2RS,3RS)-3-(2-Chlorophenyl)-2-(4-fluorophenyl)-[1H-1,2,4-triazol-1-yl) methyl]oxirane, (3-Chloro-2-hydroxypropyl) trimethylammonium chloride, (3-Chlorophenyl)-(4-methoxy-3-nitrophenyl)methanone, (3S,5aR,9bS)-3,3a,4,5,5a,9b-hexahydro-3,5a,9-trimethylnaphto [1,2-b] furan-2,8-dione, (4-Ethoxyphenyl)(3-(4-fluoro-3-phenoxyphenyl)propyl)dimethylsilane, (4-Hydrazinophenyl)-N-methylmethanesulfonamide hydrochloride, (6-(4-Hydroxy-3-(2-methoxyphenylazo)-2-sulfonato-7-naphthylamino)-1,3,5-triazine-2,4-diyl)bis[(amino-1-methylethyl)ammonium] formate, (6R-trans)-1-((7-Ammonio-2-carboxylato-8-oxo-5-thia-1-azabicyclo-[4.2.0]oct-2-en-3-yl)methyl)pyridinium iodide, (8-[(4-Amino-2-nitrophenyl)azo]-7-hydroxy-2-naphthyl) trimethylammonium, (8-[(4-Amino-2-nitrophenyl)azo]-7-hydroxy-2-naphthyl) trimethylammonium chloride, (E)-3-[1-[4-[2-(Dimethylamino)ethoxy]phenyl]-2-phenylbut-1-enyl]phenol, (Methylenebis(4,1-phenylenazo(1-(3-(dimethylamino)propyl)-1,2-dihydro-6-hydroxy-4-methyl-2-oxopyridine-5,3-diyl)))-1,1'-dipyridinium dichloride dihydrochloride, (R) 5,6,6a,7-Tetrahydro-6-methyl-4H-dibenzo[de,g]quinoline-10,11-diol, (R)-5-Bromo-3-(1-methyl-2-pyrrolidinylmethyl)-1H-indole, (R)-α-Phenylethylammonium (-)-(1R,2S)-(1,2-epoxypropyl)phosphonate monohydrate, (S)-2,3-Dihydro-1H-indole-carboxylic acid, (Z)-2-Methoxymino-2-[2-(tritylamino)thiazol-4-yl]acetic acid, (µ-((7,7'-Iminobis(4-hydroxy-3-((2-hydroxy-5-(N-methylsulphamoyl) phenyl)azo)naphthalene-2-sulphonato))(6-)))dicuprate(2-), (µ-((7,7'-Iminobis(4-hydroxy-3-((2-hydroxy-5-(N-methylsulphamoyl) phenyl)azo)naphthalene-2-sulphonato))(6-)))dicuprate(2-), disodium salt, 1,1-Bis(dimethylaminomethyl)propyl benzoate, 1,2-Benzenedicarboxylic acid, di-C6-8-branched alkylesters, C7-rich, Previous consultations on ECHA’s Executive Director Requests to the Committees, Applications for authorisation consultations, Harmonised classification and labelling consultations, ECHA Executive Director’s requests related to the CLH process, Consultation on potential candidates for substitution, Consultation on derogation to the exclusion criteria, ECHA's Executive Director Requests to the Committees, Consultation on a draft recommendation for amendment of Authorisation List entries, Consultations in the authorisation process, Occupational exposure limits - Call for comments and evidence, Occupational exposure limits - Previous calls for comments and evidence, Occupational exposure limits – Consultations on OEL recommendation, Derogations for the protection of cultural heritage, ECHA's current activities on restrictions, ECHA's completed activities on restriction, Information on Candidate List substances in articles table, Information from the Existing Substances Regulation (ESR), PBT/vPvB assessments under the previous EU chemicals legislation, Adopted opinions and previous consultations on applications for authorisation, Adopted opinions on restriction proposals, Mapping exercise – Plastic additives initiative, Occupational exposure limits substance evaluations, List of substances subject to POPs Regulation, Small and Medium-sized Enterprises (SMEs), Practical examples of chemical safety reports. Substances listed in Annexes III to VI do not cover nanomaterials, except where specifically mentioned. Part A of Annex I to Regulation (EC) No 1223/2009 lists the data that is to be available, ‘ as a minimum ’, for the safety assessor to be able to carry out the safety assessment. Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (recast) (Text with EEA relevance) ... ANNEX II. Due to a high volume of changes being made to legislation for EU exit, we have not been able to research and record them all. After exit day there will be three versions of this legislation to consult for different purposes. From 3 September 2021 hair and eyelash dye products containing those substances shall not be placed on the Union market. This site additionally contains content derived from EUR-Lex, reused under the terms of the Commission Decision 2011/833/EU on the reuse of documents from the EU institutions. Amendment to Regulation (EC) No 1223/2009. The following results are legislation items with 'EU Exit' in their title that directly reference and therefore may change this item of legislation. No changes have been applied to the text. The directive shall enter into force on 11 June 2019. Where those effects have yet to be applied to the text of the legislation by the editorial team they are also listed alongside the legislation in the affected provisions. Description List of substances prohibited in cosmetic products from Annex II of the Regulation (EC) No 1223/2009 of the European Parliament and of the Council as amended. The entry in annex … Revised legislation carried on this site may not be fully up to date. Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 On cosmetic products. This directive shall enter into force on the twentieth day following that of its publication in the OJ(i.e. On November 12, 2020, three new amendments to the Cosmetics Regulation (EC) 1223/2009 were published. Allowed Preservatives: Annex V, Regulation 1223/2009/EC on Cosmetic Products, as amended by Regulation 2019/1966/EU, 28 November 2019 . Changes and effects are recorded by our editorial team in lists which can be found in the ‘Changes to Legislation’ area. This Regulation shall be binding in its entirety and directly applicable in all Member States. Article 119. EN 2 EN ANNEX In Annex II to Regulation (EC) No 1223/2009, in the table, the following three entries are added: Reference number Substance identification 2 May 2019, the Official Journal of European Union released the directive (EU) 2019/680 and 2019/681, to amend the Annex II and Annex VI to Regulation (EC) 1223/2009 on cosmetics products. REACH regulation aims to improve the protection of human health and the environment from the risks that can be posed by chemicals. Indicates the geographical area that this provision applies to. European Cosmetics Regulation 2019/831 has been published. On June 12, Commission Regulation (EU) No 2019/831 /EU of 22 May 2019 entered into force amending Annexes II, III and V to the Regulation 1223/2009.. What has changed? 23 May 2019, the Official Journal of European Union released the directive (EU) 2019/831, amending the Annex II, III and V to Regulation (EC) No 1223/2009 on cosmetic products. Turning this feature on will show extra navigation options to go to these specific points in time. ‘Eye product’ means a cosmetic product which is intended to be applied in the vicinity of the eyes; ‘Professional use’ means the application and use of cosmetic products by persons in the exercise of their professional activity. LIST OF SUBSTANCES PROHIBITED IN COSMETIC PRODUCTS. Changes that have been made appear in the content and are referenced with annotations. In effect, it amends Annexes II, III, and V of Regulation 1223/2009/EC. This website uses cookies to ensure you get the best experience on our websites. These substances will therefore be added to Annex II of Regulation 1223/2009. The POPs Regulation bans or severely restricts the production and use of persistent organic pollutants in the European Union. You may also experience some issues with your browser, such as an alert box that a script is taking a long time to run. This regulation shall enter into force on 21 May 2019. ANNEX II, Last update: 24/11/2020 LIST OF SUBSTANCES PROHIBITED IN COSMETIC PRODUCTS Reference number Substance identification Chemical name / INN CAS Number EC Number Update Date 1 N-(5-Chlorobenzoxazol-2-yl)acetamide 35783-57-4 - 17/10/2010 2 (2-Acetoxyethyl)trimethylammonium hydroxide (Acetylcholine) and its salts 51-84-3 200-128-9 17/10/2010 Occupational exposure limit (OEL) values are derived within two legal frameworks that form an integral part of the EU’s mechanism for protecting the health of workers. The dates for the EU versions are taken from the document dates on EUR-Lex and may not always coincide with when the changes came into force for the document. … EU. Welcome to the ECHA website. Regulation (EC) No 1223/2009 came in to force on 11 January 2010 (twentieth day after its publication in the Official Journal of the European Union on 22 December 2009) and was fully implemented on 11 July 2013 when Directive 76/768/EEC was repealed. The directive (EU) 2019/680 and 2019/681 are … Commission Regulation (EU) No 358/2014 amends annex II and V of Regulation (EC) No 1223/2009. This regulation shall enter into force on 21 May 2019. You may also experience some issues with your browser, such as an alert box that a script is taking a long time to run. From 3 June 2022 hair and eyelash dye products containing those substances shall not be made available on the Union market. Return to the latest available version by using the controls above in the What Version box. (EU) 2020/1682 amending Annex III to the Regulation, (EU) 2020/1683 amending Annexes II and III to the Regulation, and (EU) 2020/1684 amending Annex VI to the Regulation. Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (recast) (Text with EEA relevance). Regulation (EC) No 1223/2009 of the European Parliament and of the Council (2). It removes isopropylparaben and its salts; isobutylparaben and its salts; phenylparaben; benzylparaben; and pentylparaben from annex V and adds them to annex II. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance. Changes we have not yet applied to the text, can be found in the ‘Changes to Legislation’ area. B REGULATION (EC) No 1223/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 30 November 2009 on cosmetic products (recast) (Text with EEA relevance) (OJ L 342, 22.12.2009, p. 59) Amended by: Official Journal No page date M1 Commission Regulation (EU) No 344/2013 of 4 April 2013 L 114 1 25.4.2013 Corrected by: There are changes that may be brought into force at a future date. See how this legislation has or could change over time. This list contains substances which are banned from use in any cosmetic products marketed for sale or use in the European Union. In total, EC No. Prohibited Substances: Annex II, Regulation 1223/2009/EC on Cosmetic Products, as amended by Regulation 2019/1966/EU, 28 November 2019 . What is the Classification and Labelling Inventory? In addition to the minimum data listed in Part A of Annex I to Regulation (EC) No 1223/2009, the safety assessor can use any additional data, where relevant. It repeals the EU cosmetics Directive (Directive 76/768/EC) and comes into force on 11 July 2013. The Support section provides tools and practical guidance to companies which have responsibilities under the EU chemicals legislation. Part A of Annex I to Regulation (EC) No 1223/2009 lists the data that is to be available, ‘ as a minimum ’, for the safety assessor to be able to carry out the safety assessment. In order to facilitate substance identification, the following descriptors are used: The Non-proprietary Names (INN) for pharmaceutical products, WHO, Geneva, August 1975; The Chemical Abstracts Service numbers (CAS); The EC number which correspond to either the European Inventory of Existing Commercial chemical Substances (EINECS) numbers or the European List of Notified Chemical Substances (ELINCS) numbers or the registration number given under Regulation (EC) No 1907/2006; The XAN which is the name approved by specific country (X), e.g. Reference to enclosed or attached information. Close Find out more on how we use cookies. Period-after-opening. In addition to the minimum data listed in Part A of Annex I to Regulation (EC) No 1223/2009, the safety assessor can use any additional data, where relevant. The Waste Framework Directive aims to protect the environment and human health from the generation and management of waste and to improve efficient use of resources. Regulation (EC) No 1223/2009 of the European Parliament and of the Council, Preamble to Annexes II to VI is up to date with all changes known to be in force on or before 17 November 2020. amending Annex II to Regulation (EC) No 1223/2009 of the European Parliament and the Council on cosmetic products . This list contains substances which are banned from use in any cosmetic products marketed for sale or use in the European Union. The list contains maximum concentration limits and other restrictions. The Whole Regulation you have selected contains over 200 provisions and might take some time to download. In effect, it amends Annexes II, III, and V of Regulation 1223/2009/EC. For more information see the EUR-Lex public statement on re-use. For any versions created after the implementation period as a result of changes made by UK legislation the date will coincide with the earliest date on which the change (e.g an insertion, a repeal or a substitution) that was applied came into force. This regulation shall be binding in its entirety and directly applicable in all Member States. 1 August 2018). Regulation (EC) No 1223/2009 of the European Parliament and of the Council, ANNEX II is up to date with all changes known to be in force on or before 15 August 2020. This is unique source of information on the chemicals manufactured and imported in Europe. It strengthens the safety of cosmetic products and streamlines the framework for all operators in the sector. The data from Cosing are only provided for your information. In order to implement this paragraph, the Commission shall amend the Annexes to this Regulation in accordance with the regulatory procedure with scrutiny referred to in Article 32(3) of this Regulation within 15 months of the inclusion of the substances concerned in Part 3 of Annex VI to Regulation (EC… BPR regulation aims to improve the functioning of the biocidal products market in the EU, while ensuring a high level of protection for humans and the environment. Any changes that have already been made to the legislation appear in the content and are referenced with annotations. Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (recast) (Text with EEA relevance) Use the ‘more’ link to open the changes and effects relevant to the provision you are viewing. Geographical Extent: While EC No. The legislation.gov.uk version is the version that applies in the UK. There may be changes and effects to this Legislation not yet recorded or applied to the text. The web archive also captured associated case law and other language formats from EUR-Lex. REGULATION (EC) No 1223/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL. (EU) 2020/1682 amending Annex III to the Regulation Regulation (EC) No 1223/2009 of the European Parliament and of the Council, See the EU version of this legislation on EUR-Lex, See an archived version from EUR-Lex in the web archive, the original print PDF of the as adopted version that was used for the EU Official Journal, lists of changes made by and/or affecting this legislation item, links to related legislation and further information resources, the original print PDF of the as adopted version that was used for the print copy, confers power and blanket amendment details. The Commission may, at the request of a Member State or on its own initiative, adopt the necessary measures to determine whether or not a specific product or group of products falls within the definition ‘cosmetic product’. This substance is a mixture of cis and trans isomers, of which the cis-isomer has been classified as a CMR substance of category 2. Article 2 From 22 November 2019 hair dye products, including eyebrow dye products, and eyelash dye products containing the substances prohibited by this Regulation … - A new Regulation in force since 11 July 2013 – The Cosmetics Regulation(1223/2009), published in the Official Journal of the European Union on 22 December 2009, replaces the Cosmetics Directive(76/768/EC), which has been governing the composition, labelling and packaging of finished cosmetic products in the European Union since 1976. Annex I is For the purposes of the Annexes II to VI: ‘Rinse-off product’ means a cosmetic product which is intended to be removed after application on the skin, the hair or the mucous membranes; ‘Leave-on product’ means a cosmetic product which is intended to stay in prolonged contact with the skin, the hair or the mucous membranes; ‘Hair product’ means a cosmetic product which is intended to be applied on the hair of head or face, except eye lashes; ‘Skin product’ means a cosmetic product which is intended to be applied on the skin; ‘Lip product’ means a cosmetic product which is intended to be applied on the lips; ‘Face product’ means a cosmetic product which is intended to be applied on the skin of the face; ‘Nail product’ means a cosmetic product which is intended to be applied on nails; ‘Oral product’ means a cosmetic product which is intended to be applied on teeth or the mucous membranes of the oral cavity; ‘Product applied on mucous membranes’ means a cosmetic product which is intended to be applied on the mucous membranes. 12 July 2018, the Official Journal of the European Union issues a directive (EU) 2018/978, amending the Annex II and Annex III of the Regulation (EC) 1223/2009 on cosmetics products. The CLP Regulation ensures that the hazards presented by chemicals are clearly communicated to workers and consumers in the European Union through classification and labelling of chemicals. List of substances prohibited in cosmetic products from Annex II of the Regulation (EC) No 1223/2009 of the European Parliament and of the Council as amended. Registration, Evaluation, Authorisation and Restriction of Chemicals, Chemical Agents Directive and Carcinogens or Mutagens Directive, Cosmetic Products Regulation, Annex II - Prohibited Substances, Substances of very high concern identification, Recommendation for the Authorisation List, Getting started with EU chemicals legislation, Classification of substances and mixtures, Harmonised classification and labelling (CLH). 3. In Article 2 of Regulation (EC) No 1223/2009, the following paragraph is added: ‘4. 1223/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 30 November 2009. on cosmetic products (recast) (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EURO­ PEAN UNION, Having regard to the Treaty establishing the European Commu­ nity, and in particular Article 95 thereof, From 3 June 2022 hair and eyelash dye products containing those substances shall not be made available on the Union market. Lexparency.org Regulation (EC) No 1223/2009 view on EUR-LEX. ANNEX II — LIST OF SUBSTANCES PROHIBITED IN COSMETIC PRODUCTS; ... Regulation (EC) No 1223/2009 Status Cosmetic Products Regulation ANNEX VII Version ANNEX VII — SYMBOLS USED ON PACKAGING/CONTAINER 1. First of all, the Regulation takes into account compounds classified as CMR substances (carcinogenic, mutagenic or toxic to reproduction) in accordance with the Regulation No. The list contains the substance identification (Chemical name/INN, CAS Number and EC number) of each prohibited substance. Regulation (EC) No 1223/2009. 1223/2009, Annex II is the same as it is under the Cosmetics Directive; however, the EU has made it even more difficult to use. For further information see ‘Frequently Asked Questions’. Cannabidiol was inserted in Annex II (list of prohibited substances) of EU Cosmetics Regulation due to the referral to “all substances listed in Tables I and II of the Single Convention on Narcotic Drugs signed in New York on 30 March 1961”. 3 1 Commission Regulation (EU) N° 655/2013 of 10 July 2013 … This list contains substances designated as preservatives which cosmetic products marketed in the EU may contain. These substances will therefore be added to Annex II of Regulation 1223/2009. Access essential accompanying documents and information for this legislation item from this tab. To understand whether or not the text of this legislation is up to date, please check those references in the following pieces of legislation. Dependent on the legislation item being viewed this may include: Click 'View More' or select 'More Resources' tab for additional information including: All content is available under the Open Government Licence v3.0 except where otherwise stated. In principle, this would be sufficient to rule out any legal use of CBD in cosmetic products. Regulation (EC) N° 1223/2009 on cosmetic products is the main regulatory framework for finished cosmetic products when placed on the EU market. 1272/2008 /EC (CLP) of 1st December … The Schedules you have selected contains over 200 provisions and might take some time to download. amending Annex II to Regulation (EC) No 1223/2009 of the European Parliament and the Council on cosmetic products . More information is available about EU Legislation and UK Law. ANNEX III. Different options to open legislation in order to view more content on screen at once. Prohibited Substances: Annex II, Regulation 1223/2009/EC on Cosmetic Products, as amended by Regulation 2019/1966/EU, 28 November 2019 This list contains substances which are banned from use in any cosmetic products marketed for sale or use in the European Union. In force since ... ANNEX II — LIST OF SUBSTANCES PROHIBITED IN COSMETIC PRODUCTS; (10) Products which combine a medicinal product or substance and a medical device are regulated either under this Regulation or under Directive 2001/83/EC of the European Parliament and … Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 On cosmetic products. Lexparency.org Regulation (EC) No 1223/2009 view on EUR-LEX. This site is not fully supported in Internet Explorer 7 (and earlier versions). 2. REGULATION (EC) No . The EU Version currently on EUR-lex is the version that currently applies in the EU i.e you may need this if you operate a business in the EU. 1 August 2018). Annex II to Regulation (EC) No 1223/2009 is amended in accordance with the Annex to this Regulation. 1223/​2009, often called the Recast or the 8th Amendment, is comprised of a preamble with 71 parts (justifi­cation), 40 articles (replacing the old 15) and 10 annexes (replacing the old nine). There are outstanding changes not yet made to Regulation (EC) No 1223/2009 of the European Parliament and of the Council. Article 119. EU. The Commission may, at the request of a Member State or on its own initiative, adopt the necessary measures to determine whether or not a specific product or group of products falls within the definition ‘cosmetic product’.