Europe Regulatory News

On 29 June 2022, the European Commission published its draft agenda for the second half of 2022. The agenda contains the meetings to take place between July and December 2022. Approval of a text at a ...

On 29 June 2022, the European Commission published its draft agenda for the second half of 2022. The agenda contains the meetings to take place between July and December 2022. Approval of a text at a joint meeting of all Commissioners is the last step for the Commission to formally adopt it as a proposal. Therefore, the topics to be discussed in meetings are an indication of what files the EU executive is expecting to advance on.

In relation to chemicals legislation, two key proposals are mentioned in the draft agenda. First, the revision of Regulation (EC) 1272/2008, on the classification, labelling and packaging of substances and mixtures (the CLP Regulation) will be discussed in late October according to the schedule. Second, new rules on intentionally added microplastics will be discussed in late November.

If progress on both initiatives aligns with these timelines, negotiations between the Parliament and the Council on these two key initiatives would be an important part of the legislative agenda in 2023.

Another key piece of legislation when it comes to chemicals – the revision of Regulation (EC) 1907/2006, concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) – is not mentioned in the agenda. This could signal that it will be delayed and presented in 2023.

This would be consistent with the fact that, while all three initiatives have seen delays relative to their initial expected timelines, the CLP review and the microplastics proposal are more overdue than the REACH revision.

At the Green Economy Business Summit on June 8, 2022, it was highlighted that the successful implementation of the Chemicals Strategy for Sustainability (CSS) is "preconditioned" so that the European ...

At the Green Economy Business Summit on June 8, 2022, it was highlighted that the successful implementation of the Chemicals Strategy for Sustainability (CSS) is "preconditioned" so that the European chemical industry is able to keep its competitiveness.

Another underlined emphasis is their stand that for the timeline of REACH revision, there will be no compromising for the CSS as long as it is steered in the right way. The main concern discussed was the fear of decreasing the competitiveness of the bloc’s industry on the global market upon imposing the stricter regulation of chemicals in the EU.

The Commission is now working on a transition pathway to earn more time for the industry to adapt to any upcoming regulatory changes, intending to continue the new innovation and competitiveness the regulatory system has brought to the EU market and industries. Although several external factors such as the war in Ukraine has however hampered the measures under the CSS to be implemented holistically, the Commission expects no postponement, in general, to fulfil the EU’s toxic-free future.

According to two studies done by trade body, Cefic, regarding the potential impact of changes to REACH in 2021, it plans to increase hazard classes to the CLP Regulation and extension of the Generic Risk Approach (GRA) could possibly lead to a loss of 12% of the EU chemical portfolio by 2040. Plus, the introduction of a Mixture Assessment Factor (MAF) of ten could as well impose high costs for the industry, along with significant turnover losses and job losses.

Despite the conducted studies, it is believed that the transition pathway planned as a collaborative exercise with relevant stakeholders shall provide the industry with a clearer idea to manage and put things together by the end of 2022 ideally.

The Helsinki Chemicals Forum held from June 8 to 9, 2022 was a great success, from which key highlights of the industry were discussed brilliantly. This is a hybrid event, a first of its kind and ther...

The Helsinki Chemicals Forum held from June 8 to 9, 2022 was a great success, from which key highlights of the industry were discussed brilliantly. This is a hybrid event, a first of its kind and there were more than 200 international policymakers, industry representatives, NGOs and academicians who attended the event.

Some of the discussions centred around the need to accelerate chemical regulations, to define sustainable by design chemicals, to merge chemical risk management with circularity and climate policy objectives, to speed up the replacement of animal testing, and the role of a global science-policy interface panel.

The session on the integration of chemical risk management with circularity and climate policy objectives was moderated by Steve Van de Broeck, the director of REACH and Chemicals Policy, Cefic. This is called the 3Cs and it is aimed at helping the EU meet the EU Green Deal goals. This integration is possible but would not be a smooth one due to conflicting and competing interests such as short and long-term benefits and differences in environmental aims.

Following the panel discussion on replacing animal testing, there is a consensus that there is a need to replace animal testing and most regulations are now tilting towards its replacement. Animal testing is time consuming, expensive, and sometimes not accurate to speculate the chemical effects on humans. Although new approach methods (NAMs) are coming up, their implementation is slow and most regulatory bodies need assurance that these NAMs are as effective as the use of animals for testing.

Also, NAMs are more readily available for endpoints such as aquatic toxicity and genotoxicity which is not the same for the more challenging endpoints such as carcinogenicity, immunotoxicity, and endocrine disruption.

A key update regarding animal testing is the project set up by the European Partnership for Alternative Approaches to Animal Testing (EPAA). The project ‘Use of NAMs for regulatory decisions on chemical safety’ has workstreams that are studying the application of NAMs within the industry.

The full report can be accessed here.

On June 22, 2022, the European Commission opened a consultation period for proposed amendments to Annex VI of Regulation 1272/2008 on Classification, Labelling, and Packaging of substances and mixture...

On June 22, 2022, the European Commission opened a consultation period for proposed amendments to Annex VI of Regulation 1272/2008 on Classification, Labelling, and Packaging of substances and mixtures (The CLP Regulation).

Annex VI of the CLP Regulation relates to harmonized labelling and classification of most hazardous chemicals. Part 3 of said Annex lists the substances subjected to harmonization, including, for instance, their hazard class and category, hazard statements, pictograms, and signal words. Harmonized entries also contain references to a list of notes that seek to provide further clarity on the obligations applicable to any given substance. Notes are drawn from a list of notes that can be found in Part 1 of the same Annex, and they can refer to the classification and labelling of either substances or mixtures.

The Commission is currently consulting on the addition of three additional notes to the overall list of notes. One of the new entries would relate to the classification of substances, and it would clarify that where harmonization entries relate to a group of substances, they only apply to the part that said substances have in common. The remaining two proposed entries relate to the calculation of the relevant thresholds for the classification of mixtures as reproductive toxicants in some specific cases.

Public consultation is open until July 20, 2022. The proposal is for a delegated act within the CLP Regulation, which empowers the Commission to adapt specific provisions to technical progress. Delegated acts benefit from a quicker adoption procedure: once the Commission adopts its proposal (after taking public contributions into account), it will automatically become law after two months unless Parliament or Council explicitly object.

The European Chemicals Agency (ECHA) releases a new SCIP Candidate List package to align with the inclusion of more substances on the Candidate List. This will help companies to create SCIP notificati...

The European Chemicals Agency (ECHA) releases a new SCIP Candidate List package to align with the inclusion of more substances on the Candidate List. This will help companies to create SCIP notifications that include the new substances.

The IUCLID reference substance approach is needed when providing information about Candidate List substances in your SCIP notifications. Although reference substances can be created in IUCLID, ECHA recommends the use of their pre-made SCIP package which for instance can then be imported to IUCLID.

Previously, the SCIP Candidate list was updated on July 2021. For SCIP notifications, the new candidate list reference substance package includes:

• Individual reference substance datasets
• A change log of the candidate list package
• Delta package reference substance datasets
• A list of reference substance

SCIP is the database for information on Substances of Concern In articles as such or in complex objects (Products) established under the Waste Framework Directive (WFD). Companies supplying articles containing substances of very high concern (SVHCs) on the Candidate List in a concentration above 0.1% weight by weight (w/w) on the EU market have to submit information on these articles to ECHA.

The Candidate List of substances of very high concern now contains 224 entries as one substance N-(hydroxymethyl)acrylamide (CAS No. 924-42-5) has been added on June 2022. Before this, the Candidate List of substances of very high concern was updated on January 2022 which consisted of total 223 (219+4) entries as four new substances were added:

• 6,6'-di-tert-butyl-2,2'-methylenedi-p-cresol (CAS No. 119-47-1)
• tris(2-methoxyethoxy)vinylsilane (1067-53-4)
• (±)-1,7,7-trimethyl-3-[(4-methylphenyl)methylene]bicyclo[2.2.1]heptan-2-one covering any of the individual isomers and/or combinations thereof (4-MBC)
• S-(tricyclo(5.2.1.02,6)deca-3-en-8(or 9)-yl O-(isopropyl or isobutyl or 2-ethylhexyl) O-(isopropyl or isobutyl or 2-ethylhexyl) phosphorodithioate (255881-94-8).

Companies are responsible for managing the risks of these chemicals and must also give their customers and consumers enough information to use them safely as these can harm people or the environment.                                                                                                                                  

On July 1, 2022, the European Commission published a guidance document addressing the relationship between the REACH Regulations and the EU sanctions recently imposed under Council Regulations 269/201...

On July 1, 2022, the European Commission published a guidance document addressing the relationship between the REACH Regulations and the EU sanctions recently imposed under Council Regulations 269/2014 and 833/2014.

The new document explains that data owners cannot engage in negotiations for data sharing and other transactions with a person who is appointed under Council Regulation 269/2014 or owned/controlled by an appointed person under the regulation on ‘Sanctions adopted following Russia’s military aggression against Ukraine’. All ongoing negotiations are expected to be suspended. Also, companies or groups of companies who entered into agreements with other companies before designation under Council Regulation 269/2014 or owned/controlled by an appointed person under the regulation should take all necessary actions while considering the business operations and current agreements.

Funds cannot be sent to someone who is appointed/designated under Council Regulation 269/2014 or owned/controlled by an appointed person under the regulation. Such funds can be in an escrow account and ECHA will get involved if there is a disagreement.

Under Council Regulation 269/2014, lead registrants should be changed. Also, lead registrants cannot submit information and dossier updates for persons that are designated under the regulations. Furthermore, only representatives cannot represent anyone appointed/designated under Council Regulation 269/2014 or owned/controlled by a designated person under the regulation. The full guidance document can be accessed here.

On June 22, 2022, the European Parliament and Council reached an agreement on a proposal by the European Commission to review Annexes IV and V of Regulation (EU) 2019/1021, on persistent organic poll...

On June 22, 2022, the European Parliament and Council reached an agreement on a proposal by the European Commission to review Annexes IV and V of Regulation (EU) 2019/1021, on persistent organic pollutants (POPs). The allowable limits were discussed and lowered which means tightened global limits for six substance groups and one for the newly listed substance perfluorohexane sulfonic acid (PFHxS). 

The presence of POPs in waste is a barrier to the development of a circular economy – one of the major objectives of the European Green Deal – and the Commission’s proposal sought to introduce limits for new POPs and to tighten acceptable maximums for several POPs that are already in the regulation.

The agreement sets threshold levels of the following limits according to a June 21 Council of Ministers' press release:

• 200mg/kg for polybrominated diphenyl ethers (PBDEs). The new limit will apply five years after the entry into force of the legislation. Until then, the limit is set at 500mg/kg, which will be lowered to 350mg/kg after three years. The current limit is 1,000mg/kg.   
• 1mg/kg for perfluorooctanoic acid (PFOA) and its salts, and 40mg/kg for PFOA-related compounds. 
• 5 microgram (μg) toxic equivalency quotient/kilogram (TEQ/kg) for polychlorinated dibenzo-p-dioxins and dibenzofurans (PCDD/Fs), with some transitional measures, where the current limit for PCDD/Fs is 15μg/kg. 
• 1mg/kg for PFHxS and its salts and 40mg/kg for PFHxS-related compounds - after the entry into force, these values will be reviewed five years; furthermore, though this substance was not initially included in the Commission’s proposal, it was supplemented during the trialogue procedure, following its listing in the Stockholm Convention on June 9.
• 500mg/kg for hexabromocyclododecane (HBCDD), which will be lowered to 200mg/kg five years after entry into force of the regulation. 
• 500mg/kg for polybrominated diphenyl ethers (PBDEs), which will be lowered to 350mg/kg three years after entry into force of the regulation, with another reduction to 200mg/kg after five years, and  
• 1,500mg/kg for short-chain chlorinated paraffins (SCCPs), with a review clause five years after the entry into force.   

In May, Parliament voted for stricter limits to accelerate the transition towards a circular economy. It also proposed that the Commission would consider amendments to EU waste legislation clarifying that waste containing POPs above their allowed concentration limits is hazardous waste.

Legislation proposals need the agreement of both Parliament and Council to become law. After having held negotiations, both institutions have reached an informal agreement. It includes some new POPs in the regulation (including some not initially proposed by the Commission) and updates the concentration limits for others. The agreed text is a compromise between the high ambition of Parliament and the demands for higher limits and slower timelines put forward by the Council.

Additionally, the amendments will require the Commission to assess the convenience of amending waste law in line with Parliament’s proposal.

While an informal agreement has been reached, this will not yet become law. Both the Parliament and the Council will now launch formal proceedings to adopt the agreed text, which will enter into force once both institutions have endorsed it. A final vote is scheduled in the European Parliament this autumn to decide on the provisional agreement.