Europe Regulatory News

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.

On 10 June 2022, the European Commission released a new recommendation updating the definition of nanomaterials that should inform EU legislation on the topic. A deliverable of the EU Chemicals Strate...

On 10 June 2022, the European Commission released a new recommendation updating the definition of nanomaterials that should inform EU legislation on the topic. A deliverable of the EU Chemicals Strategy for Sustainability, this new recommendation updates the definition established in Recommendation 2011/696/EU. Being set out in Commission recommendations, the definitions are not binding, but they orient the application of relevant legislation and can be used in binding rules and regulations.

The new definition clarifies the characteristics of particles composing nanomaterials. While the 2011 Recommendation only defined them in general terms, the new one specifies rules for particles having elongated or plate-like shapes.

The new definition also eliminates a flexibility clause relative to the threshold for the amount of particles under a certain size. In the 2011 Definition, the general rule was that nanomaterials were materials composed of at least 50% of said particles. However, in cases justified on environmental, health, safety or competitiveness grounds, lower thresholds may apply. The possibility of establishing lower thresholds is not included in the new recommendation. This is expected to minimize the potential for divergence between different legal frameworks.

While the definition is not binding, it will orient the development of the legal framework, for instance, in relation to upcoming reviews of general and product-specific chemicals legislation.

On June 22, 2022, the European Parliament adopted its negotiating position on the European Commission’s proposal for a regulation establishing a Carbon Border Adjustment Mechanism (CBAM). In the...

On June 22, 2022, the European Parliament adopted its negotiating position on the European Commission’s proposal for a regulation establishing a Carbon Border Adjustment Mechanism (CBAM).

In the EU, certain industrial sectors must purchase the right to emit greenhouse gases through a system known as the Emissions Trading Scheme. However, stakeholders have expressed concerns that this puts EU producers at a disadvantage, and that the relocation of industrial activities prevents the attainment of emission reduction objectives.

The CBAM would address these concerns by requiring importers to purchase certificates (“CBAM certificates”) reflecting the price of carbon that they would have paid if their products had been produced in the European Union. Among other issues, the Commission’s proposal includes details on the covered products, the calculation of their embedded emissions, and the price of CBAM certificates.

While the European Parliament has overall welcomed the Commission’s draft regulation, it has proposed some amendments to its coverage and timeline. In addition to the product scope proposed by the Commission (iron and steel, aluminium, electricity, cement, organic basic chemicals and fertilizers), the Parliament is proposing to make the system applicable to hydrogen, polymers (i.e. plastics), and organic chemicals. In relation to organic chemicals and polymers, the proposed amendments would see the Commission carry out a study to assess their specific challenges. The Commission would then be able to propose technical adjustments or the delay of the CBAM entry into force relative to these product groups.

Other proposed changes concern the allocation of revenues raised through the scheme, the implementing authority, and the basis for the calculation of embedded emissions. Negotiations between Parliament and the Council of the EU, representing the Member States, will now begin. Both institutions must agree on a final text. The adoption of Parliament’s common position has seen delays in the initial vote, which was scheduled for June 8. This reflects the contentious nature of the proposal, which therefore might still see important changes before becoming law.

The European Commission opens consultation till July 8, 2022, on the exemption of hexavalent chromium usage. According to the proposal, the exemption of the use of hexavalent chromium as an anticorros...

The European Commission opens consultation till July 8, 2022, on the exemption of hexavalent chromium usage. According to the proposal, the exemption of the use of hexavalent chromium as an anticorrosion agent in gas absorption heat pumps (GAHPs) will end on December 31, 2026.

This consultation is under Annex III of the Directive on the restriction of hazardous substances (RoHS) in electronic and electrical equipment. The exemption is due to the unavailability of other anticorrosion agents. Also, other heat pumps that are available have less energy efficiency.

The Commission evaluates that with this exemption, about 38g of hexavalent chromium will be used per GAHP and around 1,400 kg would be placed on the market annually.

Generally, some hazardous substances are restricted in Electrical and Electronic Equipment (EEE) under the Directive of RoHS. However, specific, and time-limited exemptions can be granted for substances when requested by stakeholders, as long as the request/substance meets the necessary criteria.

On the 15th of June 2022, the European Commission notified its draft decision to not approve methylene dithiocyanate as an existing active substance to be used in biocidal products of product-type 12....

On the 15^th of June 2022, the European Commission notified its draft decision to not approve methylene dithiocyanate as an existing active substance to be used in biocidal products of product-type 12. This is in accordance with Regulation (EU) No 528/2012 of the European Parliament and the Council.

This new decision means that biocidal products of product-type 12 containing methylene dithiocyanate are not expected to meet the criteria laid down in Article 5(1) for specific points. It is quite challenging to confirm the minimum purity of the active substance and to set a reference specification for the substance considering applicants’ inability to submit data of an excellent quality to meet data requirements in points 2.7, 2.8, and 4.1.

Point 2.7: Specification of purity of the active substance in g/kg or g/l, as appropriate

Point 2.8: Identity of impurities and additives together with the structural formula and the possible range expressed as g/kg or g/l, as appropriate.

Point 4.1: Analytical methods for the determination of the pure active substance and where appropriate, for relevant degradation products, isomers, and impurities of the active substance and additives.

All these points are of Title II of Annex IIA to Directive 98/8/EC. It is also impossible to confirm that the materials used to conduct ecotoxicological studies cover the presented specifications and to conclude on the impurities’ relevance since there is no ecotoxicological data.

Additionally, an environmental risk assessment identified unacceptable risks and there is no suitable risk mitigation measure to adopt. The proposed date of adoption is September 2022 and entry into force will be 20 days from its publication in the Official Journal of the EU.