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Food contact declaration of compliance kit for plastics: Regulation (EU) No 10/2011

Plastic materials and articles intended to come into contact with food, such as containers, lids, bottles, films and kitchenware, need a written declaration of compliance at every stage of marketing except retail, and supporting documentation for the authorities. Type your company and articles once; the kit writes these documents as Word files you can edit and sign.

Checked against the sources on 17 October 2026

Business operator issuing the declaration (your company)
The bisphenol declaration needs a telephone number or an email address.
Manufacturer or importer, if not your company (optional)

Point 2 of the declaration. Leave empty if your company manufactures or imports the articles.

Materials and articles

Article 1
As on your price list or drawing, for example FC-500.
Batch or lot numbers, or how the batch is marked, so the declaration identifies what it covers.
For example: polypropylene food container with lid, 500 ml.
Foods it is intended for (Annex III, Table 2)

Tick each food category. The names are the English text of the Regulation; the kit prints the food simulants of each row as the table assigns them.

0 chosen

Added to point 8(i) of the declaration as you type it, for example hard cheese and cold meats.

Worst foreseeable contact: time and temperature

Each stage of use, in order: for example 2 hours at 70 °C (hot fill), then 6 months storage. The kit looks up the test conditions in Annex V.

Stage 1
Point 8(ii) of the declaration lists the stages above as you typed them, then this text, for example: for storage at room temperature, hot fill up to 85 °C.

Repeated-use articles are tested three times (Annex V, point 2.1.6).

Choose the test whose conditions cover the use. The text of the Regulation shows under your choice.

Declaration of compliance

One per line, for example FCM No 151, SML 5 mg/kg. Ask your resin and additive suppliers: their declarations give them. Point 6.
One per line, with their specific migration or purity data, or None. Point 7.
For example 6 dm² per kg of food, or equivalent information. Point 8(iii).

Yes writes the confirmation of point 9 (Articles 13 and 14); No writes Not applicable.

Yes leaves the confirmation and specification of point 10 to complete; No writes Not applicable.

Yes writes the confirmation of point 11 (Article 8(1)); No writes Not applicable.

Laboratory, report number, date, simulant, conditions and result.

Bisphenols (Regulation (EU) 2024/3190)

Bisphenol A may not be used to manufacture plastic food contact materials (Article 3).

Languages of the declarations (your customers' countries)

Nothing you type is sent anywhere. Your business details stay in this browser for next time.

What the rules ask for

  • A declaration of compliance with the information of Annex IV of Regulation (EU) No 10/2011 (Article 15). It identifies the materials or articles it covers and is renewed when substantial changes in the composition or production change the migration, or when new scientific data become available.
  • Supporting documentation showing that the material or article complies: the conditions and results of testing, calculations, modelling or other analysis, made available to the national authorities on request (Article 16).
  • A declaration of compliance under Regulation (EU) 2024/3190 (Article 8) for materials and articles within its scope, listing any bisphenols or bisphenol derivatives used. Bisphenol A may not be used to manufacture plastic food contact materials (Article 3).
  • Good manufacturing practice: a documented quality assurance system, quality control and documentation (Regulation (EC) No 2023/2006, Articles 5 to 7).

What the declaration of compliance must contain

Annex IV of Regulation (EU) No 10/2011 lists eleven points. In short:

  1. who issues the declaration, with address;
  2. who manufactures or imports the material or article, with address;
  3. which materials or articles it covers;
  4. the date of the declaration;
  5. confirmation that they meet Regulation (EU) No 10/2011 and Articles 3, 11(5), 15 and 17 of Regulation (EC) No 1935/2004;
  6. information on the substances with restrictions or specifications in Annexes I and II, and on non-intentionally added substances, so that the next business operator can check compliance;
  7. information on substances that are also restricted in food, with their level of specific migration from tests or calculation;
  8. the conditions of use: the types of food, the time and temperature of treatment and storage, and the highest surface-to-volume ratio for which compliance was verified;
  9. for a multi-layer material or article with a functional barrier, confirmation of Article 13(2) to (4) or Article 14(2) and (3);
  10. for a batch of material intended for reprocessing, confirmation of Article 10(1) and (2) and of the good manufacturing practice rules, with its composition and reprocessing instructions as appropriate;
  11. for authorised substances manufactured from waste, confirmation that they comply with point (1) of Article 8.

Points 9 to 11 apply only in their own case. The kit prints the eleven points in the wording of the Official Journal, with your answer against each.

Migration test conditions from the tables

For each food category you tick, the kit prints the food simulants that Table 2 of Annex III assigns, with the notes on correction factors and omitted simulants. For each stage of use you type, it looks up the test time and temperature in Tables 1 and 2 of Annex V, and for storage above 30 days the case of point 2.1.4. Where the tables do not settle it, such as exactly 175 °C, it says why and leaves TO COMPLETE instead of choosing. It does not apply the derogations of point 2.1.3; your laboratory decides on those.

Free templates and this kit

The declaration itself is not secret: Annex IV of Regulation (EU) No 10/2011 lists what it must contain, and trade associations publish model declarations free of charge. What a template leaves to you is the work behind it: which food simulants each food category needs, the test time and temperature for each stage of use, the bisphenol declaration of Regulation (EU) 2024/3190, and the supporting documentation the authorities ask for. The kit fills those in from what you type; the two declarations quote the Official Journal.

What is in the files

  • the declaration of compliance for each article, in each language you choose, in the wording of Annex IV published in the Official Journal;
  • the bisphenol declaration for each article, in the same languages, in the wording of Annex III of Regulation (EU) 2024/3190;
  • the supporting documentation for each article: composition, substances with restrictions, food simulants, test conditions, overall migration, test reports;
  • a good manufacturing practice record, and a read-me with what the kit leaves out.

What the kit does not do

It does not test materials, choose your substances or their limits, or replace a laboratory. Whatever you leave empty is marked TO COMPLETE, and the declarations say Confirmed or Not applicable only where you answered. The kit never writes that an article complies. It covers finished plastic materials and articles, not intermediate products, substances, recycled plastic, ceramics or active and intelligent materials. For substances of very high concern in other products, see the REACH SVHC declaration.

Nothing you type leaves your browser; the files are built on your device. Templates, not legal advice. The declarations quote the Official Journal; everything you type stays as you typed it and is not translated. The other files are in English, with the food categories and test conditions as the English text of the Regulation words them.

Sources