Declarations and documents demonstrating safety and regulatory compliance

In every step of trading except for retail, the materials and articles must include the documentation demonstrating their regulatory compliance. Each contact material operator’s manufacturer must present a so called declaration of compliance covering the producing steps that they are responsible for.

The declaration of regulatory compliance has two main objectives:

  • It confirms to the client that the product fulfils the necessary requirements defined in the framework regulation and in material-specific legislation.

  • It provides the client with necessary information to ensure or check that the product has been manufactured according to relevant legislation.

    Material-specific legislation gives separate instructions for the declaration of regulatory compliance for ceramics, plastic, recycled plastic, active and intelligent materials and supplies, regenerated cellulose and varnishes and coatings including bisphenol A.

    More specific instructions on the contents of a declaration of compliance of plastic materials can be found in the EU Commission’s guidelines.

     https://ec.europa.eu/food/sites/food/files/safety/docs/cs_fcm_legis_pm-guidance_reg-10-2011_sans-boxes_finl.pdf

    The content requirements of a declaration of compliance for plastic materials can be used, so far as applicable, as an example for other food contact materials. In many EU countries, there is no national legislation or recommendations about declarations of compliance for harmonised materials.

    In Finland, the obligation to write a declaration of compliance for all food contact materials is explained in Evira’s guideline number 17018. The guidelines also explain the general content requirements of said declaration. The information provided must be clear, and it must not be misleading or uncertain.

    Material-specific legislation gives separate instructions for the declaration of compliance for ceramics, plastic, recycled plastic, active and intelligent materials and supplies, regenerated cellulose and varnishes and coatings including bisphenol A.

    General information about the declaration of compliance (adapted from the DoC instructions of the plastics regulation):

  • The information provided must be clear, and it must not be misleading or uncertain.

  • The information should relate to the material’s actual composition, and one declaration cannot cover several materials that have a different composition and therefore considerable differences in their raw materials.

  • One declaration can, however, cover some variants of the material or article in cases where size, shape, thickness or colour, or the acquisition source of one or some ingredients varies.

  • The document must itemise the products from the product family it covers and declare which product the entire product family’s declaration is based on.

  • The evidential documents (such as test results and risk assessment results) that explain the basis of the choice must be easily accessible for the authorities.

    Regulatory compliance measures

  • The declaration of compliance and sufficient information about the safety and regulatory compliance of the material confirm that the operator has taken the necessary regulatory compliance measures.

  • Potential regulatory compliance measures depend on the operator’s position in the supply chain and the operator’s obtainable information.

  • If the declaration of compliance includes a general disclaimer, it cannot invalidate the details presented in the declaration.

  • The regulatory compliance measures cover a risk assessment that also assesses the harmfulness of substances in the material or added into it, and the likelihood of them being released into food.

  • Since the producing processes of materials are often complex, regulatory compliance measures cannot usually be implemented in a single phase.

  • For example, information about chemical composition, the presence of unintentionally added substances such as pollutants and degradation products, usage conditions of the material, food composition and storage and contact conditions are not evident in each phase of the supply chain.

  • The best possible exchange of information is therefore of utmost importance to ensure the regulatory compliance of the final product.

  • Mutual communication within the supply chain can help reveal important information to help suppliers and clients to implement their regulatory compliance measures.

  • It also increases trust among operators, which is important for the safety of the final product.

    Delivering the declaration of compliance to a client

  • There is no need to attach the declaration of compliance to the goods and send it to a client with every reorder.

  • It should instead be delivered to the client on paper or electronically, or if the client approves, it can be downloaded from the website.

  • The declaration must always be updated if legislation is significantly changed and/or if there is a change in the substance’s/material’s composition or purity, that affects the given declaration.

  • The supplier must notify the client of such updates. The client is not legally required to request an update if there is a change in legislation, but it is good practice.

  • The declaration of compliance must immediately be presented to the food authorities upon request.