A DoC can be issued only with information on the product for which it is issued. This information includes all compliance tasks carried out by the business operator issuing the DoC, as reflected in the supporting documents.
In accordance with Article 16 of Regulation (EU) No. 10/2011, supporting documents “shall include the conditions and results of testing, calculations, including modelling, other analysis, and evidence on the safety or reasoning demonstrating compliance”.
Supporting documents are generated and updated by the business operator issuing the DoC and are not intended to be sent throughout the supply chain. They should be delivered to the competent national authorities upon request. The DoC received by the business operator from the supplier will form part of its compliance tasks, as well as other information such as product test results.
In order to facilitate the work of business operators when drawing up the DoC, Annex IV of Regulation (EU) No. 10/2011 provides details on the information to be included. The European Union also publishes guidelines on information in the supply chain3, which aim to address the exchange of information in the supply chain on the requirements for compliance with Regulation (EU) No. 10/2011.
Article 15, Section 1 of Regulation (EU) No. 10/2011 establishes the general obligation that “at the marketing stages other than at the retail stage, a written declaration […] shall be available”. Moreover, the supplier of intermediate materials that do not include plastic, such as inks, coatings and adhesives, are not obliged to deliver a DoC unless required by national legislation, given that there is no harmonized EU requirement. However, suppliers are recommended to provide clients with suitable information.
The latest amendment of Regulation 10/2011, Regulation (EU) 2020/12454, also includes changes in the DoC. It amends Section 6 of Annex IV of this regulation to specify that the amount of limited substances in accordance with Annex II must be included in the DoC:
“(6) adequate information relative to the substances used or products of degradation thereof for which restrictions and/or specifications are set out in Annex I and II to the Regulation to allow the downstream business operators to ensure compliance with the Regulation.
At intermediate stages, this information shall include the identification and amount of substances in the intermediate material:
— that are subject to restrictions in Annex II, or
— for which genotoxicity has not been ruled out, and which originate from an intentional use during a manufacturing stage of that intermediate material and which could be present in an amount that foreseeably gives rise to a migration from the final material exceeding 0.00015 mg/kg food or food simulant.”
It is worthy of note that the Directorate-General for Health and Food Safety (DG SANTE) provides guidelines so that this information is applied to Non-Intentionally Added Substances (NIAS).
A DoC template will be established in future amendments of the plastics regulation to ensure that everyone is working with the same digital format.
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