Europe Regulatory News

On 5 May 2023 the European Food Safety Authority (EFSA) requested additional evidence regarding the potential migration of plasticisers from food contact materials (FCMs). Stakeholders and interested ...

On 5 May 2023 the European Food Safety Authority (EFSA) requested additional evidence regarding the potential migration of plasticisers from food contact materials (FCMs). Stakeholders and interested parties can submit their information until 30 June 2023.

Upon the European Commission's request, EFSA is conducting a re-evaluation of phthalates, substances with similar structures, and alternative materials utilized in FCMs. To facilitate this process, EFSA has extended an invitation for data submissions from various entities, including national food authorities, research institutions, academia, and food business operators.

This is the second call for evidence on migration data in relation to dietary exposure assessment, following a consultation conducted last year. Phthalates, terephthalates, citrates, and benzoates are some of the plasticisers that will be evaluated.

Previously, in January 2023, the European Commission proposed an update to the regulation governing plastics used in FCMs. This proposed update would introduce changes to existing authorizations and specific migration limits (SMLs) for certain uses of phthalates such as dibutyl phthalate (DBP), benzyl butyl phthalate (BBP), diethylhexyl phthalate (DEHP), and diisononyl phthalate (DINP).

At the 11th meeting of the Conference of the Parties (COP) to the Stockholm Convention on 5 May 2023, more than 120 countries agreed to add 2 plastic chemicals and one pesticide to the Conventions lis...

At the 11th meeting of the Conference of the Parties (COP) to the Stockholm Convention on 5 May 2023, more than 120 countries agreed to add 2 plastic chemicals and one pesticide to the Conventions list of substances for global elimination (Annex A). The delegates to the COP found that the chemicals, the plastic additive UV-328, the flame retardant Dechlorane Plus (also often used in plastics), and the pesticide methoxychlor all meet the Convention criteria as persistent organic pollutants (POPs) required for a global ban.

The uses and hazards of the 3 substances are:

However, time-limited exemptions were agreed on for the use of UV-328 and Dechlorane Plus. The expemtions are summarised in the tables below.

Several countries called for labelling of products that contain the 2 plastic additives while others opposed. The Convention’s Scientific Review Committee plans to evaluate options for identifying POPs in products and waste.

On 28 April 2023 the European Commission put forward a proposal for a revised Regulation on detergents and surfactants that would amend Regulation (EU) 2019/1020 and repeal Regulation (EC) No 648/2004...

On 28 April 2023 the European Commission put forward a proposal for a revised Regulation on detergents and surfactants that would amend Regulation (EU) 2019/1020 and repeal Regulation (EC) No 648/2004. The new proposal introduces digital labelling and product passports for detergents and surfactants, new requirements for cleaners containing micro-organisms as well as rules for refilled detergents. This proposal updates the existing rules in line with the objectives of the European Green Deal, the Chemicals Strategy for Sustainability and the recently adopted Commission Communication on the long-term competitiveness of the EU.

Detergents are chemicals with intrinsic properties that have the potential to pose risks to human health and the environment. In order to be placed and move freely on the EU market detergents need to comply with Regulation (EC) No 648/2004 (the ‘Detergents Regulation’) from 2004. The regulation contains labelling and biodegradability requirements and phosphorous limits. However. the Detergents Regulation does not take into account innovative products such as microbial cleaning products and sustainable new practises such as refill sales. Furthermore, there are overlaps between the Detergent Regulation and the Classification, Labelling and Packaging (CLP) Regulations leading to e.g. duplication of information of the emergency health response for detergents classified as hazardous under the CLP Regulation. The revised Regulations will address these issues.

The revised Regulation will ensure that the EU rules specific for detergents remain complementary to the general provisions applicable to chemicals i.e. the CLP Regulation and the REACH regulation. The revised Regulation puts forward the following changes:

Introduction of safety requirements for micro-organisms in detergents: New innovative cleaning products that use the action of micro-organisms have recently been developed. The revised Regulation will introduce safety requirements for micro-organisms in detergents. Furthermore, manufacturers must label the presence of micro-organisms in the detergents. This will allow these products to move freely in the Single Market and contribute to protecting human health and the environment since they may be alternatives to harmful chemicals.

Introduction of product passports: A product passport that contains compliance information will be introduced which will reduce the amount of non-compliant detergents and surfactants on the market in the EU. A detergent that is presented at customs can only be released for free circulation ad placed on the market if it has a corresponding product passport. National inspectors will continue to be responsible for carrying out checks on products, although a new IT system will screen all digital product passports at the external borders.

Introduction of voluntary digital labelling: For pre-packaged products some of the mandatory labelling information may be move to a digital label. For refillable products all labelling information may be provided digitally – except for dosage instructions for consumer laundry detergents.

Introduction of rules for refilled detergents: Under the revised Regulation refilled detergents are subject to the same rules as pre-packaged detergents. Furthermore, voluntary digital labelling is introduced for refilled detergents to further facilitate the use of these as this is sustainable and reduces packaging waste.

Simplification of market rules by abolishing unnecessary or redundant requirements: The following rules in the Detergent Regulation will be abolished:

• the obligation to provide an ingredient data sheet for hazardous detergents

• the obligatory involvement of approved laboratories performing tests

• the possibility to request a derogation for surfactants that do not meet the criteria of ultimate biodegradability

• the obligation for detergent and surfactant manufacturers to be established in the EU

Furthermore labelling requirements will be simplified and streamlined to reduce the administrative burden for the industry and making them easier to understand for end-users.

The complete text of the revised Regulation can be found here: https://single-market-economy.ec.europa.eu/publications/com2023217-proposal-regulation-detergents-and-surfactants_en

The European Commission has finally adopted restrictions prohibiting the use and sale of lead in polyvinyl chloride (PVC) articles, including imports in order to safeguard individuals and the environm...

The European Commission has finally adopted restrictions prohibiting the use and sale of lead in polyvinyl chloride (PVC) articles, including imports in order to safeguard individuals and the environment against the harmful impacts of lead. The primary beneficiaries of this measure are people's health, especially children. These efforts align with the objectives of the Chemical Strategy for Sustainability and the European Green Deal.

Lead compounds are commonly found in PVC products used in the construction industry, such as window profiles, pipes, tubes, wires, and cables. Implemented within the framework of EU REACH, this restriction is expected to prevent the release of approximately 8.4 tonnes of lead emissions annually.

Since the regulation’s entry into force on 28 May, the industry has 18 months to transition and must now add a warning label to the packaging of relevant products.

To encourage recycling and reduce carbon emissions by 1.5 million tonnes annually, items made from recycled rigid PVC can still be sold and used for ten years after the 28 May entry into force. However, only if the rigid PVC contains less than 1.5% lead in the recovered rigid PVC, and less than 0.1% lead for a layer of newly produced PVC. Furthermore, these recycled rigid PVC items must be entirely coated with a lead-free layer to ensure safety and prevent accidental exposure to lead for both people and the environment.

The United Nations Recommendations on the Transport of Dangerous Goods, commonly known as the UN Model Regulations, are maintained, and amended by the UN Sub-Committee of Experts on the Transport of D...

The United Nations Recommendations on the Transport of Dangerous Goods, commonly known as the UN Model Regulations, are maintained, and amended by the UN Sub-Committee of Experts on the Transport of Dangerous Goods (TDG Sub-Committee). The UN Model Regulations, which are updated every two years, serve as the foundation for unified international and national dangerous goods transit legislation.  

Following the UN Committee of Experts' acceptance of the revisions to the UN Recommendations on the Transport of Dangerous Goods in December, the 23rd amended edition will shortly be released. Duty holders do not need to take any action at this time because the revisions won't take effect until the beginning of 2025. The numerous model, regional, and national agencies in charge of the laws that businesses must abide by will spend the interim time incorporating the revisions into their rules. 

Listing and distinctive provisions  

The following list contains  some of the significant modifications made to the 23rd updated edition of the Model Regulations: 

•  New entries in the Dangerous Goods List 

• One new special provision specific to sodium ion cells and batteries, namely SP 401New paragraph added after paragraph 5:  UN 3556 VEHICLE, LITHIUM ION BATTERY POWERED, UN 3557 VEHICLE, LITHIUM METAL BATTERY POWERED and UN 3558 VEHICLE, SODIUM ION BATTERY POWERED, as applicable, apply to vehicles powered by lithium ion, lithium metal or sodium ion batteries transported with the batteries installed.     

• The final two phrases in the former paragraph 6 (now paragraph 7) have been merged to form the following:    

• UN 3558 is subject to a new SP 404, while the three newly adopted entries for battery-powered vehicles are all subject to a new SP 405 

• A new SP 400 grants a broad exemption for UN 3552 alone, acknowledging the negligible risk that sodium ion batteries in equipment represent. 

• A new SP 407 is necessary due to the implementation of new entries for fire suppressant dispersion equipment. 

• Only Class 9 of the UN 3559 standard shall be applied to fire suppression dispersal equipment. 

• SP 408 and SP 409, two brand-new special provisions, have been approved and assigned to UN 1835. 

• Additionally, SP 310 has been changed to read as follows: "2.9.4 (a), (e) (vii), (f) (iii), (f) (iv), and (g) shall not apply to cells or batteries from production runs of not more than 100 cells or batteries, or pre-production prototypes of cells or batteries when these prototypes are transported for testing."  

On the UNECE website, the online version of the 23rd revised edition of the UN Model Regulations will be released when it is ready (for reference, the 22nd revised edition debuted in September 2021); a notice will be posted on the publications page and the dangerous goods main page. 

On 5 August 2021, the Commission Regulation (EU) 2021/1297 was released to restrict the use of perfluorocarboxylic acids (C9-C14 PFCAs), their salts, and C9-C14 PFCA-related compounds under entry 68 o...

On 5 August 2021, the Commission Regulation (EU) 2021/1297 was released to restrict the use of perfluorocarboxylic acids (C9-C14 PFCAs), their salts, and C9-C14 PFCA-related compounds under entry 68 of REACH Regulation (EC) No. 1907/2006 Annex XVII.   

Starting on 25 February 2023, there is an EU-wide update for restriction on perfluorocarboxylic acids (PFCAs) with a chain of 9 to 14 carbon atoms, as well as their salts and related compounds.  . Some uses have been granted longer transition periods.  

The restriction will take effect on 4 July 2023, and it will apply to PFCAs used in the production of specific products such as polyvinylidene fluoride (PVDF) and polytetrafluoroethylene (PTFE), as well as textiles that are oil- and water-resistant to protect workers from hazardous liquids that could endanger their health and safety. 

From 4 July 2025 onwards the restriction will apply to substances used in invasive and implantable medical devices, photolithography or etch processes in semiconductor manufacturing, photographic coatings applied to films, and firefighting foam for liquid fuel vapour suppression and liquid fuel fire. 

Fluoropolymer and fluoroelastomer manufacture, as well as the production of PTFE micropowders, are all permissible under exemptions granted by the European Commission. 

For the total of C9-C14 PFCAs in fluoroplastics and fluoroelastomers containing perfluoroalkoxy groups, the concentration limit will be 2,000 parts per billion (ppb) up until 26 August 2024. However, this limit will thereafter be lowered to 100 ppb. Also, the Commission has established a limit of 1,000 ppb for the total amount of C9-C14 PFCAs, their salts, and associated compounds when present in PTFE micro particles. Both exemptions will be evaluated by 26 August 2024. 

Per- and polyfluoroalkyl substances (PFASs) include PFCAs as a subset. The much-awaited ECHA proposal to set limits on more than 10,000 PFASs was released last month. 

On 22 March 2023 the European Chemical Industry Council (Cefic) and 30 other associations representing market sectors in the European plastics value chain published a joint letter to the European Comm...

On 22 March 2023 the European Chemical Industry Council (Cefic) and 30 other associations representing market sectors in the European plastics value chain published a joint letter to the European Commission. In the letter they call on the European Commission and Member States to adopt EU harmonized calculating rules for recycled content, by means of mass balance credit method with a fuel-use exempt model, in 2023. The Single Use Plastics Directive (SUPD) Implementing Act should be used as legal foundation.

The mass balance chain of custody tracks specific characteristics and guarantees that the chemically recycled monomers and basic polymers are correctly certified. This methodology is already used in other sectors where sustainable materials are included in a mixed production process such as fair-trade cocoa and chocolate.

In order to reach the EU’s 2050 climate and circularity targets the chemical recycling infrastructure needs investments. The Plastic industry needs legal certainty on the mass balance chain of custody in order to make the necessary investments in the recycling infrastructure.