What an active or intelligent material declares to the business it is sold to
An active or intelligent material or article — one that extends the shelf-life of packaged food, or monitors its condition — must be accompanied by a written declaration of compliance at every marketing stage except retail. Article 12 of Regulation (EC) No 450/2009 requires it; Annex II says what it contains — ten numbered points and no form. This free tool assembles those ten points in each of the 22 languages, in the Regulation's own wording. It does not test your material, and it does not decide whether it complies.
Which materials are covered
Three Regulations carry a declaration under Article 16 of Regulation (EC) No 1935/2004, and they do not all work the same way. Two prescribe content — a numbered list of what the declaration must say, with no form to follow: Regulation (EU) No 10/2011 for plastics, and Regulation (EC) No 450/2009 for active and intelligent materials. The third prescribes a form — Regulation (EU) 2022/1616 for recycled plastic, whose Annex III is a template with numbered sections, boxes to tick and a signature block. This page is the second: a content list, not a form.
Plastic materials and articles are covered by Regulation (EU) No 10/2011, and its Annex IV declaration is on the food contact plastics page. Recycled plastic is covered by Regulation (EU) 2022/1616 in addition to 10/2011, and its Annex III declarations are on the recycled plastics page. This page is neither: it is for active and intelligent materials, which are defined by what they DO to the food or tell you about it, not by what they are made of. An active plastic sachet is in scope here AND under 10/2011.
What this page does not cover. Ceramics have their own specific measure (Directive 84/500/EEC) and regenerated cellulose film another (Directive 2007/42/EC), and neither prescribes the content of a declaration, so neither can be generated from the act's own words. Materials with no specific measure at all fall under Article 3 of Regulation (EC) No 1935/2004 and have no prescribed declaration to print.
The declaration
Annex II prescribes content, not a form. Article 16 of Regulation (EC) No 1935/2004 requires the written declaration and says nothing about what it looks like; this Regulation's Annex II lists ten things it must contain, two of them with sub-items. So there is no model to reproduce here: no numbered boxes, no unique identification code, no signature block, no notified body and no CE marking — the CE marking does not exist in food-contact law. What you produce below is a document carrying ten pieces of information, and its layout is yours.
One point is conditional, in the act's own words. Point 10 applies when a functional barrier is used. Points 8 and 9 introduce their sub-items with “such as”, so those are examples rather than a closed list. Leaving point 10 empty when no functional barrier is used is correct, and the counter beside the document does not count it.
The renewal duty is inside the annex, not in an article, and it is the last thing Annex II says. The written declaration must permit easy identification of what it is issued for, and must be RENEWED when substantial changes in the production bring about changes in the migration, or when new scientific data are available. It is printed at the end of the document below because that is where the annex puts it.
What is not here. Article 11 requires the business operator to hold documentation showing that the material or article and its components meet the requirements — the experiments, calculations and evidence behind what you declare — available to the competent authority on request. That is a separate obligation from this document, and no generator can produce it: it is your test data.