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Declaration of FCM compliance and supporting documents

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The harmonised EU framework regulation requires that a written declaration in accordance with Article 16 of Regulation (EC) No 1935/2004 must be available for all materials and articles, intermediated products or semi-finished products at any stage of the commercial cycle, except for the retail stage. Information was found or received from MS competent authorities. It thus can only be as exhaustive as the input or feedback obtained for the purpose of this report.

Overview of national measures or information in the EU MSs regarding DOC and supporting documents (SDs):

MSs Legislation DoC Supporting documents
– Specific use(s) intended for the material

– Written declaration on compliance with provisions of Art. 16 of Reg. 1935/2004 for all FCMs (all stages except retail), intermediate products and semi-finished products thereof, as well as substances

– DoC has to be reissued if any change takes place

NO Reg. 1381/1993 (Art. 4a, 25a); Food Act Ch. II, §14, 15 – DoC has to be issued by the company. – SDs to substantiate compliance

– Submitted to Authority on request

– Food Act requires provision of SDs to the enforcing bodies.

Norden Guidance “FCMs: In-house documentation and traceability, Nordic check lists to industry and trade” (Ch. 2, 3 and 4) Information to be inserted in the DoC for each actor of the chain:

 Name and address of supplier

 Information on substances/materials

 Risk assessment of chemicals

 Information on restrictions

 traceability

 information on use

 DoC shall be updated when changes happen


– lists of information to be retrieved by suppliers to prepare an appropriate in-house SD.

– SDs have to support all information required in the DoC

SE Norden Guidance, in chapters 2, 3 and 4 (see above)

General guide on food packaging safety from Normpack

– DoC must be produced for materials that are governed by regulations and directives for specific products and substances, i.e. plastics, ceramics, epoxy derivatives, elastomers, rubber, cellophane (regenerated cellulose) and for active and intelligent materials

– Applies to all materials

– Reports as example Reg. EU 10/2011 requirements among which:

 Identity and address of the business operator

 Type of material

 Date of the declaration

 Declaration that the material is compliant with the requirements of the reference legislation

 Information on the presence of any restricted substance with its levels of specific migration

 Specific use(s) intended for the material


– Annex 5 gives examples of questions to be answered in self-monitoring,

– Annex 6 reports the Normpack certificate as example of a document in which a neutral party certifies the FCMs is fit for purpose and that consultation has taken place between food producer and packaging supplier.

Mentions the need of SDs.

(The packaging manufacturer is responsible for having documentation available that shows what the packaging can be used for)

SI Act on health suitability of foodstuffs (repealed at end of 2015)

Art. 20, 24

– States that FCMs that are being imported may bear a certificate from an authorised body of the exporting country stating that they are health-compliant. – provisions of SDs to inspectors on:

 Type, composition and purity of raw material

 Chemicals used in the manufacture of FCMs


ES Guida para la Implantación de las buenas prácticas de fabricación para empresas que elaboran materiales y objetos destinados a estar en contacto con alimentos) done by CONSEBRO- Asociación de Industrias Agroalimentarias de Navarra, La Rioja y Aragón,

section 5.6, Annex 4, point 1, 3

 Manufacturers must have a DoC (for regulated materials) or a document that certifies the suitability of the material in contact with food (for materials where it is not obligatory to draw up a DoC)

 The final article can only be compliant if all the requirements have been met throughout the production chain

 DoC has to be required from raw materials suppliers

 Compliance must be documented at each stage of manufacturing


– It reiterates the need of complete documentation regarding the life of the materials/products and production process but without specific link to DoC, such as:

– Specifications

– Formulae

– Processes relevant to compliance and safety of the finished material or article

– Records covering the various manufacturing operations performed which are relevant to compliance and safety of the finished material or article and with respect to the results of the quality control system

– Documentation must be checked and maintained

CH Joint Industry Group (JIG) on packaging for food contact prepared Provides a checklist to assess the completeness and quality of a DoC, that includes also the following required information:

 Identification and address of all involved operators

 Type of material

 Date of declaration

 Compliance with legislation

 Information about substances used

 Intended use of material



 The explanatory part of the checklist implies that SD is necessary, including it in some explanations, even without explicitly requiring it.


EU “Industrial guidelines on traceability of materials and articles for food contact” Note: By industry professional associations APEAL, BLIC, CEFIC FCA, CEI-Bois, CEPE, CEPI, CITPA, CIPCEL, CPIV, EAA, ETS, EuPC, FPE, FEFCO/ProBox, FEVE, PlasticsEurope, SEFEL  

 information that has to be documented in order to ensure traceability at all stages of the manufacture of FCM and for every company involved in the production





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