Europe Regulatory News

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of a cease of manufacture or import and added a new section explaining when the registration of a substance is no longer valid.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The new version explains how the registration process will proceed as pre-registrations are no longer valid.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

As convenient as single-use plastic seems to be, the challenges and adverse effects far outweigh its benefits. One of such is that 80 to 85% of marine ...

As convenient as single-use plastic seems to be, the challenges and adverse effects far outweigh its benefits. One of such is that 80 to 85% of marine litter in the EU is plastic material.   

On the 31st of May 2021, the European Commission released a new directive on single-use Plastics. By 3rd July 2021, the ban on single-use plastic products and marking requirements will come into force. The new EU Single-Use Plastic Directive aims to make further clarifications about plastic products that fall within that category and give further explanation about its regulations and policies. 

The new directive further mentions the reporting format to be used by member states and the deadlines for submitting their reports to the commission. The directive applies to every product considered as single-use plastic within the EU.

To find out more about these affected products and more detailed information, click our summary report to find out.

Check our summary of the Q&As.   

Latest Update: 2021-06-30

Last year, ECHA continued addressing groups of structurally similar substances instead of assessing each chemical individually. This group approach boosted the total number of chemicals assessed i...

Last year, ECHA continued addressing groups of structurally similar substances instead of assessing each chemical individually. This group approach boosted the total number of chemicals assessed in 2020 to around 1 900 – which is twice as many as in 2019 and ten times the amount screened annually between 2014 and 2018. 

From the group assessments concluded in 2020, 290 chemicals were identified as candidates for further EU regulatory risk management. Most of these will, however, require more data to be generated and confirmation of hazard before any actions can start. 

Harmonised classification is often a prerequisite for risk management actions under REACH or other EU legislation. There are over 100 substances identified, which based on currently available information, would warrant harmonised classification, but which have so far not been picked up by authorities. A lack of harmonised classification may delay risk management actions by companies or authorities. 

The group assessments have also shown that, based on the hazard and use information currently available, there is presently no need for further risk management at EU level for about two-thirds of the substances assessed. 

The progress made in clarifying the need for regulatory action for all registered substances above one tonne, can be followed through the chemical universe. 

Last update: 2021-05-25

Companies are recommended to register substances under EU REACH with an appropriate declaration of company size together with supporting documents in REACH-IT system. Qualification of micro, sm...

Companies are recommended to register substances under EU REACH with an appropriate declaration of company size together with supporting documents in REACH-IT system.

Qualification of micro, small or medium-sized (MSME) enterprise is listed in the Commission Recommendation 2003/361/EC. If a company is under the category of MSME, they would need to check if the company size has been claimed before submitting registration.

If it is observed that wrong company size has been declared, then in that case all companies including Only Representatives (OR) acting on behalf of the non-EU company should inform ECHA proactively by emailing to: sme-verification@echa.europa.eu by 31 May 2021. Before ECHA begins the verification of company size, it is beneficial to declare and correct the company size which gives an advantage from a full administrative charge waiver (no admin fees penalty) and in that case company needs to pay the difference amount to the applicable registration fee. Otherwise, if ECHA finds the wrong company size after the verification process has started then, company will have to pay the balance of the correct fee and an administrative charge of up to EUR 19 900.  

It is important to regularly check your REACH-IT accounts for any messages and tasks from ECHA. Keep your registrations and your contact details up to date and react to ECHA’s requests.  

For further details kindly contact on sk@reach-onlyrep.eu