Europe Regulatory News

During the Biocidal Products Committee (BPC) meeting between October 5-14, 2021, it was decided not to allow the use of d-allethrin for product-type 18, that is, insecticides, acaricides, and products...

During the Biocidal Products Committee (BPC) meeting between October 5-14, 2021, it was decided not to allow the use of d-allethrin for product-type 18, that is, insecticides, acaricides, and products used in controlling other arthropods.

The committee regarded the toxicological test data presented in the submitted dossier and it does not appropriately match the profile of what is currently in the market. There are also unacceptable risks to human health and the environment from using d-allethrin.

Last Update: 2021-11-01

The European Chemical Agency (ECHA) announced the SCIP Database in September 2021; this is a public database for Substances of Very High Concern (SVHC) in EU products. SCIP da...

The European Chemical Agency (ECHA) announced the SCIP Database in September 2021; this is a public database for Substances of Very High Concern (SVHC) in EU products. SCIP database is aimed at helping consumers make informed purchasing choices and waste operators develop procedures for reuse and recycling of articles and materials respectively. 

About 6,000 companies in the EU have notified ECHA about their products that have SVHCs, therefore, the SCIP database has more than four million article notifications which can now be accessed by the public. 

According to ECHA, the most notified product categories in the database are: 

• machinery and their parts 

• measuring instruments and their parts 

• electronic equipment and their parts 

• vehicles and their parts 

• articles made of rubber; and 

• furniture. 

And the most common SVHCs in these notifications are: 

• lead (e.g. in ball bearings, batteries); 

• lead monoxide (e.g. in lamps, vehicle parts); 

• lead titanium trioxide (e.g. in electric cookers); 

• silicid acid, lead salt (e.g. in lead crystalware, vehicle coatings); and 

• 1,6,7,8,9,14,15,16,17,17,18,18-Dodecachloropentacyclo[12.2.1.16,9.02,13.05,10]octadeca-7,15- diene, more commonly referred to as “Dechlorane PlusTM” (e.g. in paints, glues) 

In the database, you can easily search for data either by the name or brand of the article, type of material, product category, or by the chemical name. Through the database, you can get accurate information on products; if they are hazardous and their safe use instructions. 

Do you place articles that contain SVHCs in the EU market? If yes, have you notified these substances to the database? If no, you must do the notifications. Check ECHA for guidance documents and tools for this process. 

As it started on January 5, 2021, notifying ECHA applies to companies that supply articles containing substances of very high concern (SVHCs) on the REACH candidate list. This obligation concerns articles in the EU market that contains more than 0.1% weight by weight of SVHCs.  

Last Update: 2021-10-20

Certain amendments were proposed to the 8th version of GHS at the 10th session of the "Committee of Experts on the Transport of Dangerous Goods and on the Globally Harmonized System of Classifica...

Certain amendments were proposed to the 8th version of GHS at the 10th session of the "Committee of Experts on the Transport of Dangerous Goods and on the Globally Harmonized System of Classification and Labelling of Chemicals" held on the 11th of December 2020.

The new GHS document ‘version 9’ adopted these amendments, and the main updates are listed below: 

Chapter 2.1 on explosives has new updates to address explosion hazards better when they are not in their transport configuration; (pages 41-50). The new changes include further information on:

• the classification of explosives as substance, mixture, or article
• the minimum level of packaging you can retain an explosive until use
• the substances and mixtures excluded from the class of explosives (2.1.1.2.2)
• the classification criteria (2.1.2) are now tabular for a clearer understanding of Categories 1 & 2 and their sub-categories.

Decision logics are revised on pages 46 to 48 to include images on:

• Decision logic for categories of explosives
• Decision logic for sub-categories of explosives

There is also a revision of the classification and labelling summary tables in Annex 1. The change of classification criteria in chapter 2.1 was reflected in the table, changing the Explosives GHS hazard category from Division 1.1-1.6 to 1-2c. This can be found on pages 245-259.

Other revisions in the new version include further rationalization of precautionary statements and an update of references to OECD test guidelines for chemicals testing in annexes 9 and 10 (pages 519-524 & 535).

Download the GHS Version 9 

ECHA added new updates in the Guidance on Registration in August 2021. The new updated version of the guidance document offers advanced support to the companies with thei...

ECHA added new updates in the Guidance on Registration in August 2021. The new updated version of the guidance document offers advanced support to the companies with their registration obligations. 

The Guidance on Registration was first published in June 2007 and since then, it has been revised 9 times. The updated Guidance extends information on notification of a cease of manufacture or import and added a new section explaining when the registration of a substance is no longer valid.

Another important aspect is the alignment with the Guidance on data sharing. Joint submission of data was previously mentioned in the Guidance on data sharing, now ECHA added a section (Section 4.3) on joint submission.

Now, the guidance document is associated with two European Commission implementing regulations – one on the “registration and data sharing of phase-in substances” after the final registration deadline, and the other on “updates of registration dossiers”. 

The new version explains how the registration process will proceed as pre-registrations are no longer valid. It also suggests to companies how to calculate the tonnage band they are registered for. Also, this Guidance is helpful for the companies to decide when they need to update their REACH registrations.

For more inquiries, please contact compliance@gpcregulatory.com.   

ECHA elucidates the rules on accepting adaptations for degradation testing and requiring combined studies for mutagenicity. It also suggests companies should consider these changes while deciding whether to update their registrations. 

Chemical Safety Assessment does not permit registrants to exclude the standard information on degradation of the substance from column 1 under REACH (Annex IX, section 9.2., column 2). Instead, biotic degradation testing must be proposed by companies if the chemical safety assessment indicates the need to further investigate the degradation of the substance and its degradation products. The choice of the appropriate tests depends on the results of the chemical safety assessment 

For adaptation of the degradation tests listed in column 1, companies apply the specific rules for adaptation listed in REACH Annex IX, sections 9.2.1.2-4 and 9.2.3, column 2, along with the general rules for adaptations, listed in Annex XI. As explained in Annex IX and XI, exposure-based adaptations can also be considered when human/environmental exposure is absent or so low that additional hazard information will not lead to improved risk management. But the legal basis for such adaptation must be well-defined. Also, It has been suggested by ECHA that for all adaptations, sufficient justification and documentation are needed while considering the whole lifecycle of the substance. 

Furthermore, for mutagenicity studies, a combined comet assay and micronucleus test is required for the substances registered over one tonne per year under Annex VII and also for annexes VIII, IX and X. 

The combination study will be requested if there is: for mutagenic studies 

• a positive Ames test – which checks the potential of chemicals to create mutations in bacteria. 
• an indication of a chromosomal aberration concern; and 
• no other adequate and appropriate in vivo genotoxicity data in the registration. 

This combined study can be helpful to lessen animal testing while providing useful information on the potential of a substance to induce chromosomal aberrations or gene mutation in vivo. 

REACH (EC 1907/2006) is a regulation aimed at improving the protection of human health and the environment through a better and earlier identification of the intrinsic properties of chemical substance...

REACH (EC 1907/2006) is a regulation aimed at improving the protection of human health and the environment through a better and earlier identification of the intrinsic properties of chemical substances. (Source: EC)

The EC clarification and amendment apply to Annexes VI to X of the REACH regulation. It helps clear the unclear and inconsistent words in these annexes. The draft amendment says:

• Regulation (EC) No 1907/2006 lays down specific registration duties and obligations on manufacturers, importers, and downstream users to generate data on substances they manufacture, import, or use, assess the risks related to those substances, develop and recommend appropriate risk management measures.
• Annex VI to Regulation (EC) No 1907/2006 sets out information requirements referred to in Article 10, point (a)(i) to (v) and (x) of that Regulation. Annexes VII to X of that Regulation set out standard information requirements for manufactured or imported substances in various tonnes.
• In June 2019, EC and ECHA agreed that specific information requirements in the Annexes to Regulation (EC) No 1907/2006 should be amended to provide more clarity on the obligations of registrants regarding the submission of information.
• The requirements laid down in Annex VI, sections 1 & 2 to Regulation (EC) No 1907/2006 will be amended. This is about the requirements for general registrant information and substance identification information.
• The specific rules for adaptation from the standard information requirements set out in Annexes VII to X to Regulation (EC) No 1907/2006 will be amended.
• Specific rules for adaptation from the standard information laid down in Annex VII to Regulation (EC) No 1907/2006 on mutagenicity and aquatic toxicity will be amended to ensure clarity and valuable information.
• The information requirements in Annex VIII Regulation (EC) No 1907/2006 on testing for mutagenicity, reproductive toxicity, and ecotoxicological information will be amended to clarify the obligations of registrants.
• Information requirements on testing for mutagenicity in Annex IX to Regulation (EC) No 1907/2006 should be amended.
• Annex X to Regulation (EC) No 1907/2006 should be amended to clarify specific information requirements on mutagenicity, developmental and reproductive toxicity, and ecotoxicological information.

Click on this to get a copy of the complete draft regulation and amended annexes. These amendments imply that some registration dossiers will have to be updated; therefore, a specified time (to be decided later) to apply them might be deferred.

The feedback period for this draft regulation is opened until the 19th of July 2021 (Midnight, CET). For the feedback to be taken into account for finalising the draft act, it must adhere to feedback rules, and you can find them here.

On July 9th, ECAH added eight chemicals to the Candidate List of SVHC, expanding the list from 211 to 219 entries. These newly added substances are used in consumer products such as cosmetics, sce...

On July 9th, ECAH added eight chemicals to the Candidate List of SVHC, expanding the list from 211 to 219 entries. These newly added substances are used in consumer products such as cosmetics, scented articles, rubber, textiles, or as solvents and flame retardants. They are also used for manufacturing plastics products. The Candidate List contains hazardous chemicals that are toxic to human health, specifically in reproduction, carcinogenic, respiratory sensitisers, or endocrine disruptors. Companies may have legal obligations when their substance is included – either on its own, in mixtures or articles – in the Candidate List.

Importers and producers of articles containing a Candidate List substance have to notify ECHA within six months from the date of its inclusion in the list (8th July 2021). Suppliers of substances on the Candidate List also need to provide their customers with a Safety Data Sheet (SDS).

The eight chemical substances are:

As of 5th January 2021, suppliers of articles on the EU market containing Candidate List substances in a concentration above 0.1% weight by weight have to notify these articles to ECHA’s SCIP database.

Update: 2021-07-12