Regulations Interpretation of EU Regulation EC No 282/2008 on recycled plastics

Aug. 15th, 2016
1451

Author: Wu Li, REACH24H Consulting Group, Hang Zhou

With the developing of increasing depletion of resources and continuous recycling economy, recycled plastics in the world is gradually encouraged to use. The recycled plastic used in food contact materials requires more attention. The world’s major economies, the United States, the European Union and other countries have developed guidelines registration on recycled plastic, intending strictly for registration to ensure that products is fit for using in food packaging . In this article, we provide detailed interpretation on the European Commission (EC) No 282/2008 “on recycled plastic materials and articles intended to come into contact with foods and amending Regulation (EC) No 2023/2006 ” for recycled plastic companies and stakeholders in China .

1. Regulatory requirements

In EC No 282/2008, the EU regulates only when recycled plastic from recycling processes is in accordance with the Regulations permit, can recycled plastic products be put on the market. In the Regulations, which not require security as recycled plastics and articles to be considered includes:

(1) Offcuts and scraps from the production of plastic food contact materials recycled plastic;

(2) Recycled plastic materials and articles in which the recycled plastic is used behind a plastic functional barrier, as specified in Directive 2002/72/EC;

(3) Recycled plastic materials and articles made with monomers and starting substances, derived from chemical depolymerisation of plastic materials and articles.

2. The license conditions of recycling processes

Recycled plastic can be placed on the market through a rigorous assessment processes to regenerate. In general, the assessment processes is identified on a case by case basis. Recycled plastic products and businesses should apply their recycling processes, and then put on the market after EU permission.  The main factors considered of recycling processes are as follows:

(1) Recycled plastic products used in food packaging materials, the conditions must be met with the new material and satisfy regulatory framework – Article 3 of EC No 1935/2004  as regards security provisions, and products also need to satisfy that labeling, advertising and description should not mislead consumers.

(2) Recycled plastic raw materials, additives and  contaminant removal in recycling processes should request the Regulations, raw materials used in the recycling processes only come from materials as a food contact materials and articles, and must be excluded contamination; the additive used must comply with the regulatory requirements, and the added additives in the recycling processes must also be permitted and need to comply with limits for these substances; because recycled plastics raw materials inevitably will be contaminated by some contamination from additional sources, the recycling processes need to evaluate these additional pollutants removal, this generally is to be demonstrated by conducting challenge tests.

(3) Requirements of the production processes and use condition

In accordance with regulatory requirements, and recycled plastic products must be in strict accordance with the GMP standard file –EC No 2023/2006 for production, which only satisfy the recycling processes of quality assurance system of recycled plastics can be put on the market.

In addition, it must stipulate recycled plastic products and conditions of provisions to ensure its compliance with the framework regulation EC No1935 / 2004.

3. Licensing procedures of recycling processes

Licensing procedures of recycled plastic and licensing procedures of new substances on EC1935/ 2004 are basically similar; the basic processes is to prepare application materials for the recycling processes applicant and sent to the European Food Safety Authority and conduct risk assessment, then will be given the risk assessment opinions.

4. Requires on supervision and inspection requirements and declaration of conformity

Whether plastics recycling processes is in accordance with the provisions to use and the existing quality assurance system is appropriate, the most effective way is to audit recycled plastic products and companies by the competent authorities. Audit should be in the most cost-effective way to reduce the burden of interest-related units.

In addition, according to the requirements of EC 1935/2004, the EU requires. The converter of recycled plastic material and articles should declare that he is using only recycled plastic from an authorized processes and that the final product respects

Community and national provisions applicable to it, the recycler should provide the converter with the information that the recycled plastic is produced by an authorized process and specify its field of application and prepare for declaration of conformity.

REACH24H has rich experience in dealing with United States food contact materials (FDA /FCN / 21 CFR) and EU food contact materials (EU 10/2011/BfR) and can make custom-made compliance service for enterprises. If you have further questions, please consult

+86-571-87103815

sujiandong@reach24h.cn