Commission Implementing Regulation (EU) No 321/2011 of 1 April 2011 amending Regulation (EU) No 10/2011 as regards the restriction of use of Bisphenol A in plastic infant feeding bottles (Text with EEA relevance)
Grade B
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Address https://gelex.eu/eli/EU/regulation/2011/321@2011-04-01/en
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC, and in particular Article 18(3) thereof,
After consulting the European Food Safety Authority,
Whereas:
(1) Commission Directive 2011/8/EU amended Directive 2002/72/EC relating to plastic materials and articles intended to come into contact with foodstuffs restricting the use of Bisphenol A (2,2-bis(4-hydroxyphenyl)propane) in polycarbonate infant feeding bottles.
(2) From 1 May 2011 Directive 2002/72/EC will be replaced by Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with food.
(3) Regulation (EU) No 10/2011 does not contain the restrictions concerning Bisphenol A that were introduced in Directive 2002/72/EC by Directive 2011/8/EU.
(4) Regulation (EU) No 10/2011 should therefore be amended to reflect the restrictions of use of Bisphenol A.
(5) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,
HAS ADOPTED THIS REGULATION:
Article 1
In Table 1 of Annex I to Regulation (EU) No 10/2011, the entry concerning substance number 151, named 2,2-bis(4-hydroxyphenyl)propane, in column 10 (Restrictions and specifications), the following text is inserted: Not to be used for the manufacture of polycarbonate infant feeding bottles.
Article 2
This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union. It shall apply from 1 May 2011 to prohibit the manufacture of plastic materials and articles intended to come into contact with food and which do not comply with this Regulation. It shall apply as from 1 June 2011 to prohibit the placing on the market and importation into the Union of plastic materials and articles which do not comply with this Regulation.
This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 1 April 2011. For the Commission The President José Manuel Barroso
Versions
Cited by
- Commission Regulation (EU) 2024/3190 of 19 December 2024 on the use of bisphenol A (BPA) and other bisphenols and bisphenol derivatives with harmonised classification for specific hazardous properties in certain materials and articles intended to come into contact with food, amending Regulation (EU) No 10/2011 and repealing Regulation (EU) 2018/213 (Text with EEA relevance) Regulation · Grade B
The use of BPA as a monomer in the manufacture of plastic food contact materials and articles is authorised by Commission Regulation (EU) No 10/2011. This use, as well as its presence in food contact varnishes and coatings, is subject to a specific migration limit (SML) of 0,05 mg of BPA per kg of food (mg/kg), set in Commission Regulation (EU) 2018/213 on the basis of an opinion of the European Food Safety Authority (the Authority) published in 2015. The latter Regulation also introduced a prohibition on the use of BPA in polycarbonate drinking cups and bottles for infants and young children
- Council Decision (EU) 2016/2354 of 12 December 2016 on the position to be adopted, on behalf of the European Union, within the Sanitary and Phytosanitary Sub-Committee established by the Association Agreement between the European Union and the European Atomic Energy Community and their Member States, of the one part, and Georgia, of the other, as regards the modification of Annex XI-B to that Agreement Decision · Grade B
In accordance with Article 55(4) of this Agreement, Georgia shall approximate its legislation to the following Union legislation within the timeframes as listed below. Union legislation Deadline for approximation Section 1 — Veterinary Council Regulation (EC) No 21/2004 of 17 December 2003 establishing a system for the identification and registration of ovine and caprine animals and amending Regulation (EC) No 1782/2003 and Directives 92/102/EEC and 64/432/EEC 2015 Commission Regulation (EC) No 1505/2006 of 11 October 2006 implementing Council Regulation (EC) No 21/2004 as regards the minimum
- Council Decision (EU) 2016/877 of 23 May 2016 on the position to be adopted, on behalf of the European Union, within the Sanitary and Phytosanitary Subcommittee established by the Association Agreement between the European Union and the European Atomic Energy Community and their Member States, of the one part, and the Republic of Moldova, of the other part Decision · Grade B
In accordance with Article 181(4) of this Agreement, the Republic of Moldova shall approximate its legislation to the following Union legislation within the timeframes as listed below. Union legislation Deadline for approximation Section 1 — General Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety, with the exception of Articles 58, 59 and 62 2016 Commission Regulation (EC) No 1304/2003
- Council Decision (EU) 2023/187 of 23 January 2023 on the position to be adopted on behalf of the European Union within the Sanitary and Phytosanitary Sub-Committee established by the Association Agreement between the European Union and the European Atomic Energy Community and their Member States, of the one part, and Georgia, of the other part, as regards the modification of Annex XI-B to that Agreement Decision · Grade B
In accordance with Article 55(1) of this Agreement, Georgia shall approximate its legislation to the following Union legislation within the timeframes listed below. Union legislation Deadline for approximation Section 1 - Veterinary 1. Regulation (EC) No 1760/2000 of the European Parliament and of the Council of 17 July 2000 establishing a system for the identification and registration of bovine animals and regarding the labelling of beef and beef products and repealing Council Regulation (EC) No 820/97. 2015 2. Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 Ma