Regulation (EU) No. 10/2011 on
plastic materials and articles intended to come into contact with food
New EU Regulation (EU) No. 10/2011 on plastic materials and articles
intended to come into contact with food was published on 2011 Jan 15.This
new regulation starts to effect on 2011 May 1. It repeals Commission
Directive 2002/72/EC.
Scope of the Regulation EU No.10/2011
This Regulation shall apply to materials and articles which are placed
on the EU market and fall under the following categories:
a) Material and articles and parts thereof consisting exclusively of
plastics
b) Plastic multi-layer materials and articles held together by adhesives
or by other means
c) Materials and articles referred to in pointed a)&b) that are
printed and/or covered by a coating
d) Plastic layers or plastic coatings, forming gaskets in caps and closures,
that together with those caps and closure compose a set of two or more
layers of different types of materials
e) Plastic layers in multi-material multi-layer materials and articles
This Regulation shall not apply to the following materials and articles
- TIon exchange resin
- Rubber
- Silicones
This Regulation shall be without prejudice to the EU or national provisions
applicable to printing inks, adhesives or coatings.
DECLARATION OF COMPLIANCE AND DOCUMENTATION
Declaration of compliance
Supporting Documents
1. shall contain the conditions and results of testing, calculations,
modelling, other analysis and evidence on the safety or reasoning demonstrating
compliance
2. shall be made available by the business operator to the national
competent authorities on request
Overall migration & Specific Migration Limit
1. Overall Migration
- 10mg/dm²
- 60mg/kg
2. Specific Migration (When there is no specific migration limit or
other restrictions are provided, a generic specific migration limit
of 60 mg/kg shall apply)
Transitional Provisions
- Until 2012 Dec. 31
It may accept to place the following on the market, the food contact
materials and articles which have been lawfully placed on the market
before 2011 May 1
- Until 2012 Dec. 31, supporting documents transitional provisions
Supporting documents shall be based on the basic rules for overall
migration and specific migration testing set
out in the Annex to Directive 82/711/EEC
- From 2013 Jan. 1 to 2015 Dec. 31
Supporting document for materials, articles and substances placed
on the market may be based on either the
new migration rules stated in Regulation (EU) No. 10/2011 or the rules
set out in Annex to Directive
82/711/EEC
- From 2016 Jan 1
Supporting documents shall be based on the rules for migration testing
set out in Regulation (EU) No. 10/2011
Repeal of EU directive
1. 80/766/EEC, Commission Directive method of analysis for the official
control of the vinyl chloride monomer level in material contact with
food
2. 81/432/EEC, Commission Directive method of analysis for the official
control of the vinyl chloride release by material and article into foodstuffs
3. 2002/72/EC, Commission Directive relating to plastic materials and
article for foodstuffs
For more information, please clock the hyeperlink:
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:012:0001:0089:EN:PDF
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