Commercial Information Circulars

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Ref : EIC 230/2/12

10 August 2009

Dear Sirs,

Commercial Information Circular No. 408/2009

European Union (EU)* : Control on Food Contact Materials

To protect consumer health and to avoid contamination of foodstuff, the EU has adopted various legislations to control the materials in contact with food. This circular provides a summary on the legislations relating to this subject.

DETAILS

2. The general requirements for food contact materials are set out in Regulation (EC) No. 1935/2004, which can be accessed through the following link :
   http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2004:338:0004:0017:EN:PDF
3. Under this regulation, food contact materials and articles shall be manufactured in compliance with good manufacturing practice such that, under normal or foreseeable conditions of use, they are safe to be used and do not transfer their constituents to food in quantities which could endanger human health, bring about an unacceptable change in the composition of the food or a deterioration in the organoleptic characteristics thereof.
4. Besides, the labelling, advertising and presentation of a material or article shall not mislead the consumers. Business operators shall have in place systems and procedures to allow identification of the businesses from which and to which materials or articles, substances or products used in their manufacture are supplied. This information shall be made available to the competent authorities on demand, which allows the traceability of the food contact materials and articles.
5. Furthermore, there are also specific measures on individual food contact materials, including :
   • -Ceramics, which are regulated under Council Directive 84/500/EEC (hyperlink at http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:1984L0500:20050520:EN:PDF). The Directive sets out the migration limits for cadmium and lead which might be released from decoration and/or glazing;
   • -Regenerated Cellulose Film, which is regulated under Commission Directive 2007/42/EC (hyperlink at
     http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32007L0042:EN:NOT). This Directive sets out a positive list of authorised substances and the conditions under which they may be used. Provisions for plastic coated regenerated cellulose film are also included;
   • -Plastics, which are regulated under Commission Directive 2002/72/EC (hyperlink at http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:2002L0072:20080327:EN:PDF) and its subsequent amendments. This Directive establishes an Overall Migration Limit (OML) of 60mg (of substances)/kg (of foodstuff or food simulants) that applies to all substances that can migrate to foodstuffs. The Directive also includes a positive list of authorised monomers and other starting substances with restrictions on their use (such as the Specific Migration Limit (SML) which is fixed on the basis of the toxicological evaluation of the substance), and a list of authorised additives, with restrictions on the use of certain of them. Measures on blowing agent azodicarbonamide and gasket in lids were also subsequently adopted;
   • -Recycled Plastic materials and articles, which are regulated under Regulation (EC) 282/2008 (hyperlink at http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2008:086:0009:0018:EN:PDF). The Regulation sets out the requirements for recycled plastics and establishes the authorisation procedure of recycling process used in the manufacture of recycled plastics for food contact use; and
   • -Active and intelligent food contact materials and articles, which are regulated by Regulation (EC) No. 450/2009 (hyperlink at http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:135:0003:0011:EN:PDF). Active food contact materials and articles means materials and articles that are intended to extend the shelf-life or to maintain or improve the condition of packaged food, whilst intelligent food contact materials and articles means materials and articles which monitor the condition of packaged food or the environment surrounding the food. The Regulation establishes the composition, declaration, and other labelling requirements to be complied with, and a Community list of authorised substances which may be used in the components of active and intelligent materials and articles.
6. Apart from the above Directives and Regulations, there are also three groups of substances which are regulated under individual directives:
   • -Vinyl Chloride Monomer (VCM) is regulated by Council Directive 78/142/EEC (hyperlink at
     http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31978L0142:EN:NOT), which sets the residual content of VCM in the finished material or article to be to 1mg/kg to ensure product safety. Besides, under this directive, VCM should not be detectable in foodstuffs;
   • -Nitrosamines in rubber teats and soothers are regulated by Commission Directive 93/11/EEC (hyperlink at
     http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31993L0011:EN:NOT), which establishes the SML for the substances and their derivatives; and
   • -BADGE (Bisphenol-A DiGlycidyl Ether) in plastic, coatings and adhesives are regulated under Commission Regulation (EC) 1895/2005 (hyperlink at http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2005:302:0028:0032:EN:PDF), which sets the SML for BADGE and its partially hydrolyzed products at 9 mg/kg. For the chlorohydrins of BADGE, the limit has been set at 1 mg/kg. The regulation also has prohibited the use of BFDGE (Bisphenol-F DiGlycidyl Ether) and NOGE (Novloac Glycidyl Ethers) from January 2005.
7. To facilitate manufacturers in complying with the rules and requirements, the European Commission has previously issued a Commission Regulation (EC) No. 2023/2006, which publishes a set of rules on good manufacturing practice for materials and articles intended to come into contact with food. It also specifies in its Annex the detailed rules on good manufacturing practice for processes involving printing inks and printed materials and articles. Details of the regulation can be found at the link below :
   http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2006:384:0075:0078:EN:PDF
8. For more details on EU's legislative requirements on food contact materials, please refer to the relevant webpage at the following link :
   http://ec.europa.eu/food/food/chemicalsafety/foodcontact/eu_legisl_en.htm

ENQUIRIES

9. For enquiries concerning the content of this circular, please contact the undersigned at telephone number 2398 5556.

Yours faithfully,

(Miss Peggy LEUNG)

for Director-General of Trade and Industry

* The EU includes Austria, Belgium, Bulgaria, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden and the United Kingdom.