News Details
Food Contact Materials updates in EU 2020
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FCMs regulations are fast-moving to improve the protection of public health. Food contact materials (FCMs) refer to all materials and articles intended to come into contact with food, for example, packaging and containers, machinery to process food, kitchenware, tableware. In recent years, the safety of FCMs has become an issue and one of the major concerns is that chemicals can migrate from the materials into food and may adversely affect consumer health or/and influence the quality of the food. In responding to these concerns, EU and other countries have initiated FCMs regulations and the materials/articles must be manufactured in compliance with these regulations.
On 29th April 2020 the European Food Safety Authority adopted a scientific opinion that assigns salicylic acid, styrene and lauric acid, vinyl ester as high priority candidates for re-evaluation. This scientific opinion was issued upon the request of the European Commission to review the substances without a specific migration limit (SLM) in the Plastic Regulation (EU) No 10/2011. These substances were covered by the generic SML of 60 mg/kg of food, but with Regulation (EU) 2016/1416 this SLM was removed. Of these, 179 substances were placed into the low priority group, 102 were into medium priority group and 3 mentioned above into the high priority group for future re-examination of individual chemical. Existing hazard assessments for each chemical on carcinogenicity / mutagenicity / reprotoxicity, bioaccumulation and endocrine disruptor properties were considered for the prioritization procedure.
On 20th May 2020, the European Commission issued new Farm to Fork Strategy, stating; “The Commission will revise the FCMs legislation to improve food safety and public (in particular in reducing the use of hazardous chemicals), support the use of innovative and sustainable packaging solutions using environmentally-friendly, re-usable and recyclable materials, and contribute to food waste reduction,” The Commission plans to publish the revision in the 4th quarter of 2022.
On 3rd September 2020, the European Union (EU) published Regulation (EU) 2020/1245 to amend and correct Regulation (EU) 10/2011 on plastic materials and articles intended to come into contact with food. The 15th amendment added new substances to table 1 of Annex I and introduce several changes to Regulation (EU) 10/2011. The significant changes are summarized in table 1 below. The new law has entered into force as of September 23, 2020. In accordance with the transitional provision, plastic materials and articles that were placed on the EU market before March 23, 2021, and that comply with Regulation (EU) 10/2011 as applicable before the entry into force of this amendment may continue to be placed on the EU market until September 23, 2022 and remain on the market until the exhaustion of stocks.
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Regulation (EU) 2020/1245 Amending and Correcting Regulations (EU) 10/2011 |
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Annex I Table 1. Union list of authorized monomers, other starting substances, macromolecules obtained from microbial fermentation, additives and polymer production aids |
1. A new detection limit of 0.002 mg/kg for 1,3-phenylenediamine (CAS 108-45-2) 2. Addition of three new entries
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Annex II Restrictions on plastic materials and articles |
Entire replacement of Annex II: 1. A new table 1 designates the Specific Migration Limit to 19 substances and other 5 substances whose migration limits are subject to Article 11(3) and Article 12 2. A limit of detection of 0.002 mg/kg food or food simulant for each primary aromatic amine (PAA) that is listed in entry 43 to Appendix 8 of Annex XVII to Regulation (EC) 1907/2006 3. A limit of detection of 0.01 mg/kg for the sum of PAAs, which are not listed in entry 43 to Appendix 8 to Regulation (EC) 1907/2006. |
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Annex IV Declaration of compliance |
Point 6 is replaced to include information on the amount of substances in intermediate materials |
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Annex V Compliance testing |
1. Amendment of point 2.1.3 to Chapter 2 Addition of new point (iv) that establishes rules for the migration of plastic materials or articles in food processing equipment or appliances 2. Entire replacement of point 2.1.6 to Chapter 2 ‘Repeated use materials and articles’ Migration test(s) shall be carried out three times on a single sample using a fresh portion of simulant on each occasion. The specific migration in each test must not exceed the level observed in preceding test. 3. Replacement of Table 3 under point 3.1 to Chapter 3 ‘Standardised conditions for testing the overall migration’ 4. Replacement in point 3.2 and point 3.3.2 to Chapter |
Table 1. Summary of 15th amendment of the Regulation (EU) 10/2011
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