What are the Declaration of Compliance Requirements for Products Sold for European Market?
We are producers of nylon-6 polymer that we sell in granulate form. Some of our customers use it in food packaging. We have a certificate of compliance with FDA. Do we need a 'declaration of compliance' for the European market? If so, what information does in need to contain? Also, what information are we obliged to give our clients?
The European Union's Framework Regulation, (EC) No 1935/2004, provides the basic legislation governing the use of all food-contact materials in the EU. Article 16 specifies that food contact materials and articles must be accompanied by a "written declaration stating that they comply with the rules applicable to them" and that "appropriate documentation" be made available on demand to demonstrate such compliance.
The requirement for a declaration of compliance applies to plastic materials and articles, products from intermediate stages of manufacturing, and substances intended for use in manufacturing of food contact plastics. The information that must be included in the declaration of compliance for these products and substances is set out in Annex IV of the Plastics Regulation, (EU) No 10/2011. This includes: "adequate" information to allow downstream business operators to ensure compliance with "relevant" requirements; and specifications on the use of the materials, such as intended food types and temperature restrictions.