Commission Regulation (EU) 2018/213Show full title

Article 1

For the purposes of this Regulation, the following definitions shall apply:

(1)

‘specific migration limit’ (SML) means the maximum permitted amount of a given substance released from a material or article into food or food simulants;

(2)

‘materials and articles’ means any materials or articles which fall within one of the categories laid down in Article 1(2) of Regulation (EC) No 1935/2004;

(3)

‘varnishes’ or ‘coatings’ means materials or articles composed of one or more non-self-supporting layer or layers manufactured using 2,2-bis(4-hydroxyphenyl)propane (‘BPA’), applied on a material or article in order to impart special properties on it or to improve its technical performance.

Article 2

1. The migration into or onto food of 2,2-bis(4-hydroxyphenyl)propane (‘BPA’) (CAS No 0000080-05-7) from varnishes or coatings applied to materials and articles shall not exceed a specific migration limit of 0,05 mg of BPA per kg of food (mg/kg).

2. By derogation from paragraph 1, no migration of BPA shall be permitted from varnishes or coatings applied to materials and articles specifically intended to come into contact with infant formula, follow-on formula, processed cereal-based food, baby food, food for special medical purposes developed to satisfy the nutritional requirements of infants and young children or milk-based drinks and similar products specifically intended for young children, as referred to in Regulation (EU) No 609/2013.

Article 3

1. In order to verify compliance with Article 2 of this Regulation, rules laid down in Article 11(4), in paragraphs 1, 2, 3, 6 and 7 of Article 18, in Annex III and in Chapters 1, 2 and 4 of Annex V to Regulation (EU) No 10/2011 shall apply.

2. Test results obtained as part of the verification procedure referred to in paragraph 1 shall be expressed in accordance with the rules laid down in paragraphs 1 to 3 of Article 17 of Regulation (EU) No 10/2011.

Article 4

1. In accordance with Article 16(1) of Regulation (EC) No 1935/2004, business operators shall ensure that varnished or coated materials and articles are accompanied by a written declaration of compliance containing the information laid down in Annex I to this Regulation. The declaration shall be available at all stages of manufacture, processing and distribution other than the retail stage.

2. The written declaration shall permit an easy identification of the varnished or coated materials and articles to which it applies. It shall be renewed to reflect any changes in migration levels from the varnish or coating that has been applied to materials and articles.

3. Business operators shall, upon request of a national competent authority, make available appropriate supporting documentation to demonstrate compliance with the written declaration referred to in paragraph 1. Such supporting documentation shall be provided without delay and in any event not later than 10 days following receipt of the request. The documentation shall contain the conditions and results of the testing, calculations, including modelling, other analysis and evidence on the safety or reasoning demonstrating compliance.

Article 5

Annex I to Regulation (EU) No 10/2011 is amended in accordance with Annex II to this Regulation.

Article 6

Varnished or coated materials and articles and plastic materials and articles that were lawfully placed on the market before 6 September 2018 may remain on the market until exhaustion of stocks.

Article 7

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

It shall apply from 6 September 2018.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 12 February 2018.

For the Commission

The President

Jean-Claude Juncker