Europe Regulatory News

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,...

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.

Table 1. Summary of 15th amendment of the Regulation (EU) 10/2011

On 14 September 2020, Denmark notified the WTO Committee on Technical Barriers to Trade of its enactment of an Executive order on safety requirement for toys. The purpose of the executive order is to ...

On 14 September 2020, Denmark notified the WTO Committee on Technical Barriers to Trade of its enactment of an Executive order on safety requirement for toys. The purpose of the executive order is to transpose into Danish law Directive 2019/1922/UE modifying migration limits for aluminium and Directive 2019/1929/UE laying out limit values for formaldehyde.

The two aforementioned Directives amend Directive 2009/48 on the safety of toys in the following manner:

• In point 13 of part III of Annex II to Directive 2009/48/EC (migration limits for toys and components not to be exceeded):

• In Appendix C to Annex II to Directive 2009/48/EC (Specific limit values for chemicals used in toys intended for use by children under 36 months or in other toys intended to be placed in the mouth) the following entry is added:

EU Member States are required to transpose Directive 2019/1922 by 19 May 2021 and Directive 2019/1929 by 20 May 2021.

On 8 September 2020 the EU Commission notified the WTO Committee on TBT following the publication of a draft Directive amending Directive 2009/48/EC as regards specific limit values for aniline in toy...

On 8 September 2020 the EU Commission notified the WTO Committee on TBT following the publication of a draft Directive amending Directive 2009/48/EC as regards specific limit values for aniline in toys.

In Appendix C to Annex II to Directive 2009/48/EC (Specific limit values for chemicals used in toys intended for use by children under 36 months or in other toys intended to be placed in the mouth) the following entry is added:

On 17 March 2020 the EU Commission notified the WTO Committee on TBT following the publication of a draft Directive amending Directive 2009/48/EC in the following manner: In paragraph 1 of point...

On 17 March 2020 the EU Commission notified the WTO Committee on TBT following the publication of a draft Directive amending Directive 2009/48/EC in the following manner:

• In paragraph 1 of point 11 of Part III of Annex 2 of Directive 2009/48/EC (list of allergenic fragrances which shall not be contained in toys) the following entries are added:

On 17 March 2020 the Eu Commission notified the WTO Committee on TBT following the publication of a draft Directive amending Directive 2009/48/EC in the following manner: In paragraph 3 of point 11...

On 17 March 2020 the Eu Commission notified the WTO Committee on TBT following the publication of a draft Directive amending Directive 2009/48/EC in the following manner:

In paragraph 3 of point 11 of Part III of Annex 2 of Directive 2009/48/EC (list of allergenic fragrances the name of which shall be listed on the toy, on an affixed label, on the packaging or in an accompanying leaflet if added to a toy at concentrations exceeding 100mg/kg):

The following entry is modified:

Click here to see the entries that are added. 

Some chemicals are source of increasing concern as they can cause allergic reactions after skin contact. In view of the likely exposure to sensitising chemicals foun...

Some chemicals are source of increasing concern as they can cause allergic reactions after skin contact. In view of the likely exposure to sensitising chemicals found in textiles, leather, hide and fur articles, the Swedish Chemicals Agency (KemI) and the French Agency for Food, Environmental and Occupational Health and Safety (ANSES) analysed several risk management options and proposed a restriction under REACH as the most appropriate measure to manage the possible risks that such chemicals pose to citizens. The Committee for Socio-economic Analysis (SEAC) also supports France and Sweden’s proposal to limit the use of skin sensitising substances in clothing, footwear and other articles with similar skin contact. 

KemI and ANSES’s proposal pursues to limit the concentrations of substances that have a harmonised classification as skin sensitisers in Categories 1/1A/1B listed in the CLP Regulation and that are present in these articles. It also covers disperse dyes which may cause allergic skin reactions – even if the dyes do not have a harmonised classification as skin sensitisers. 

The proposal introduces a link with the CLP Regulation meaning that any substance that is classified as a skin sensitiser in the future under CLP would automatically be covered by the restriction. When substances are automatically added to the restriction, SEAC recommends a transitional period of three years between classification and the conditions of the restriction taking effect to allow manufacturers to adapt. 

SEAC adopted its final opinion on France and Sweden’s proposal to restrict skin sensitising substances in textile, leather, synthetic leather, hide and fur articles, that are placed on the market for the first time. This further follows an earlier opinion by the Committee for Risk Assessment (RAC) in March 2020 and both committees concluded that an EU-wide restriction is the most appropriate means to address the risks to EU citizens. 

In their September meetings, RAC and SEAC also discussed applications for authorisation, other restriction proposals and harmonised classification and labelling which included following conclusions. 

• SEAC agreed its final opinion on ECHA’s proposal to restrict the placing on the market of calcium cyanamide used as a fertiliser.  
• SEAC adopted its final opinion on ECHA’s proposal to restrict five cobalt salts i.e. Cobalt carbonate, Cobalt diacetate, Cobalt dinitrate, Cobalt sulphate and Cobalt dichloride. As all of them are classified as carcinogenic, mutagenic and reprotoxic (CMR).  
• SEAC accepted its final opinion on ECHA’s proposal to restrict formaldehyde in articles, road vehicles and aircraft. 
• SEAC also received an update on the consultation comments received on ECHA’s proposed restriction of intentionally-added microplastics. The 60-day consultation on SEAC’s draft opinion ended on 1 September 2020, with 211 comments received. SEAC is expected to adopt its final opinion in December 2020. 

On October 14 the European Commission published the comprehensive Chemical strategy (EU Chemicals Strategy for Sustainability). The Strategy is the first step toward a zero pollution ambition outlined...

On October 14 the European Commission published the comprehensive Chemical strategy (EU Chemicals Strategy for Sustainability). The Strategy is the first step toward a zero pollution ambition outlined in the European Green Deal. The strategy covers a variety of dimensions, including non-toxic material cycles, banning the most harmful chemicals in consumer products, phasing out the use of per- and polyfluoroalkyl substances (PFAS) in the EU, establishing a simpler “one substance one assessment” process for the risk and hazard assessment of chemicals.

The Strategy is expected to boost innovation for safe and sustainable chemicals and increase protection of human health and the environment against hazardous chemicals.