13 March 2015
Commission Introduces Amendments to Union List of Authorised Substances for Plastic Food Contact Materials
On 6 February 2015, Commission Regulation 2015/174 amending and correcting Regulation 10/2011 on plastic materials and articles intended to come into contact with food was published in the Official Journal. The changes it introduces entered into force on 26 February 2015.
In January 2011, Regulation 10/2011 was published in the Official Journal and entered into force in May of that year. That Regulation revised Directive 2002/72/EC (which had a narrower scope), so as to cover various types of plastic contact materials including plastics used in multi-material multi-layered packaging as well as pure plastics and plastic gaskets in lids (see: 11 February 2011, Business Alert-EU).
Regulation 10/2011 affects manufacturers of plastic materials and exporters of foodstuffs to the EU as it regulates plastics which are intended to come into contact with food, are already in contact with food, or might foreseeably come into contact with food. Traders may be aware that Regulation 10/2011 applies to the following:
- materials and articles and parts thereof consisting exclusively of plastics;
- plastic multi-layer materials and articles held together by adhesives or by other means;
- materials and articles referred to above that are printed and/or covered by a coating;
- plastic layers or plastic coatings, forming gaskets in caps and closures, that together with those caps and closures compose a set of two or more layers of different types of materials;
- plastic layers in multi-material multi-layer materials and articles.
Furthermore, Annex 1 of Regulation 10/2011 provides a “Union list” of authorised substances that may be used in the manufacture of plastic materials and articles. Only substances included on this list may be intentionally used in the manufacture of plastic layers in plastic materials in articles. The Union list sets out: monomers or other starting substances; additives (excluding colorants); polymer production aids (excluding solvents); and macromolecules obtained from microbial fermentation.
Following scientific opinions from the European Food Safety Authority (EFSA), the new amending Regulation (Regulation 2015/174) introduces amendments affecting certain substances on this list. For example, for the substance 1,4-butanediol formal (FCM No 344) suitable methods to determine its presence in food are now available that weren’t before, and as a result of EFSA’s findings this substance is to be further restricted.
The new amending Regulation introduces various amendments and corrections such as the addition of new substances to the Union list in Table 1 of Annex I, the addition or deletion of Chemical Abstracts Service (CAS) numbers for several substances, and changes regarding the specific migration limit (SML) of several substances.
Concerning tartaric acid, clarification of the name of the substance (e.g. L-(+)-tartaric acid) is provided to specify that its authorisation does not extend to all other forms of that substance.
On the basis of newly available toxicological data, EFSA has increased migration limits in some instances (for example for the additive 1,3,5-tris(2,2-dimenthylpropanamido)benzene (FCM No 784)). In other cases, EFSA has extended the use of substances.
Some technical mistakes have been identified in the earlier provisions related to certain substances, and these have been rectified accordingly.
While Hong Kong businesses should pay heed to the amendments and corrections of Regulation 2015/174, affected traders may breathe a sigh of relief as this Regulation provides for a so-called “sunset period” for concerned plastic materials and articles to comply with its changes. Plastic materials and articles complying with the requirements of Regulation 10/2011 may still be placed on the EU market until 26 February 2016. Moreover, such plastic materials and articles may remain on the market after that date until the exhaustion of stocks. This provision has been included to ease the administrative burden on businesses that Regulation 2015/174 may bring.
Potentially affected traders would be advised to examine amending Regulation 2015/174 and the changes it introduces to the Union list of authorised substances. Please click the following to read Regulation 2015/174.