2 June 2017
Food Contact Plastics Regulation Subject to Further Amendments
On 29 April 2017, Regulation 2017/52 amending and correcting Regulation 10/2011 on plastic materials and articles intended to come into contact with food was published in the Official Journal of the EU. This amendment is to be implemented in two phases, which started on 19 May 2017. Hong Kong traders should take note of this development, as it will affect manufacturers of plastic food packaging and exporters of foodstuffs to the EU.
It may be recalled that on 15 January 2011, framework Regulation 10/2011 which covers plastics used in multi-material multi-layered packaging and not just pure plastics and plastic gaskets in lids (previously covered by Directive 2002/72/EC, as amended) was published.
Regulation 10/2011 sets out rules on the composition of plastic food contact materials, and is noteworthy for its Union List of substances that are permitted for use in the manufacture of plastic food contact materials. This 2011 Regulation also specifies restrictions on the use of these substances and sets out rules to determine the compliance of plastic materials and articles.
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-layer materials and articles.
Ion exchange resins, rubbers and silicones do not fall within the scope of the framework Regulation. Instead, the Regulation is concerned with plastic materials and articles which are made of a polymer to which additives or other substances may have been added and which are capable of functioning as a main structural component of final materials and articles. Notably, the Regulation is concerned about health risks from certain substances which are used in the manufacture of plastics and which can be transferred into food via migration from the plastic food contact materials.
Only substances included in Annex I to Regulation 10/2011, the so-called ‘Union List’ of authorised substances, 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.
The Union List can be amended through a specific procedure, which incorporates a risk assessment procedure, to be carried out by the European Food Safety Authority. This risk assessment covers potential migration from food contact materials under the worst foreseeable conditions of use and toxicity. Based on the risk assessment, any authorisation granted should, amongst others, set out specifications for the substance (e.g., the specific migration limit applicable to the substance) and any applicable restrictions.
Restrictions are specific requirements for the use of a substance, e.g., the requirement that a substance only be used in PET plastics, or that a substance should not be used for articles which will come into contact with certain fatty foods.
Regulation 10/2011 has now been reviewed eight times since it was issued in 2011. The initial six amendments to the Regulation were concentrated on the authorised substances contained in Annex I. The seventh amendment, Regulation 2016/1416, was of greater significance in further revising the authorised substances in Annex I, and clarified and corrected some definitions.
New Regulation 2017/752 now amends Annexes I, II, III and IV to Regulation 10/2011. The new Regulation contains a number of significant changes which Hong Kong traders should note, such as:
- Inserting six new substances to the authorised list of substances;
- A new entry for the specific migration of nickel, restricting it to no more than 0.02 mg/kg in point 1 to Annex II. With the addition of nickel, this brings the number of heavy metals with specific migration restrictions in food contact plastics to nine;
- Editorial changes to Table 3 in point 4 to Annex III (food simulant assignment for demonstrating compliance with the overall migration limit), establishing the information within a table for ease of reference;
- Replacing the residual content requirement for 10 substances with specific migration limits.
Regulation 2017/752 entered into force on 19 May 2017. However, the restrictions on the specific migration of nickel will become effective on 19 May 2019.
Regulation 2017/752 allows for food contact plastics which complied with Regulation 10/2011 before these amendments came into force, to be placed on the market until 19 May 2019. Therefore, these products can remain on the market until stocks are exhausted.
Please click on the following to examine Regulation 2017/52.