In March 2016, the European Commission (EC) proposed a new Commission Regulation (EU) on the use of bisphenol A (BPA) in varnishes and coatings intended to come into contact with food. The regulation will also amend Regulation (EU) No. 10/2011 on plastic materials and articles to come into contact with food (Plastics Regulation).
BPA is, for example, commonly used as a starting substance for inner coatings (epoxy resins) of aluminium tubes and cans for aerosols. Currently, varnishes and coatings are not covered by the "Plastics Regulation" 10/2011.
While the draft is concerned with foodstuff packaging, it indirectly also affects packaging materials used for oral and topical medicinal products since for those packaging materials compliance with foodstuff regulations is required (e.g. by the European guideline on plastic immediate packaging materials).
According to the draft the following definitions shall apply:
'varnishes' or 'coatings' means one or more non-self-supporting layer or layers composed of substances including 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,
'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,
'specific migration limit' (SML) means the maximum permitted amount of a given substance released from a material or article into food.
Additionally, the draft regulation lowers the specific migration limit (SML) for BPA from plastic food contact materials from currently 0.6 mg/kg to 0.05 mg/kg. This follows the EFSA opinion published in January 2015. The same SML applies to the migration of BPA into or onto food from varnishes or coatings.
The draft also sets out the criteria for verification of compliance concerning varnishes and coatings, as well as laying down the requirements for the written declaration of compliance (DoC) for varnished or coated materials and articles:
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.
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.
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. That documentation shall contain the conditions and results of the testing, calculations, including modelling, other analysis and evidence on the safety or reasoning demonstrating compliance.
Annex I of the draft regulation defines that the written declaration shall contain the following information:
identity and address of the business operator issuing the declaration of compliance;
the identity and address of the business operator who manufactures or imports the coated material or article;
the identity of the laboratory responsible for testing;
the identity of the varnished or coated material or article;
the date of the declaration;
confirmation that the varnish or coating applied to the material or article meets the specific migration limit laid down in this Regulation and the requirements set out in Articles 3, 15 and 17 of Regulation (EC) No 1935/2004;
specifications on the use of the coated material or article, such as: (a) type or types of food with which it is intended to be put into contact; (b) time and temperature of treatment and storage in contact with food; (c) ratio of food contact surface area to volume used to establish the compliance of the material or article.
Varnished or coated materials and articles and plastic materials and articles that were lawfully placed on the market before the date of application (to be defined) of this Regulation may remain on the market until exhaustion of stocks.