Europe Regulatory News

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

On April 14, 2021, ECHA recommends for the European Commission to add seven substances to the Authorisation List (Annex XIV of REACH). Once on the list, companies will need to apply for authorisat...

On April 14, 2021, ECHA recommends for the European Commission to add seven substances to the Authorisation List (Annex XIV of REACH). Once on the list, companies will need to apply for authorisation to continue using them.

The seven substances are:

• the cyclosiloxanes D4
• the cyclosiloxanes D5
• the cyclosiloxanes D6
• Terphenyl, hydrogenated
• DCHP
• Disodium octaborate
• TMA

The European Commission together with the EU Member States and the European Parliament will take the final decision to include these substances of very high concern (SVHCs) in the Authorisation List. After the decision is published, the date by when companies will need to apply to ECHA for authorisation to continue using the substances will also be announced.

The reason why the cyclosiloxanes D4, D5 and D6 were prioritized by EACH from the Candidate List is that they are hazardous and are usually produced in high volumes and widely used. Some uses of the cyclosiloxanes are already restricted or in the process of being restricted in consumer products and in most professional uses under REACH. The cyclosiloxanes have been prioritised for inclusion in the Authorisation List as some of their uses, for example, industrial production of electronics and some professional uses such as dry-cleaning in closed systems, are not covered by the restriction activities. 

Terphenyl, hydrogenated is used as a heat transfer fluid mainly in industrial installations as well as in adhesives, sealants, coatings, inks and paints and can also be found in some plastic articles. 

For substances DCHP, disodium octaborate and TMA, they are recommended to be in the Authorisation List because there are similar chemical structures that can be used.

Last update: 2021-04-14

In the context of the authorization process, Member States Competent Authorities and/or the European Chemicals Agency (ECHA), on request of the European Commission, could prepare Annex XV dossiers...

In the context of the authorization process, Member States Competent Authorities and/or the European Chemicals Agency (ECHA), on request of the European Commission, could prepare Annex XV dossiers for the identification of Substances of Very High Concern (SVHC).

Substances that may have serious and mostly permanent effects on human health and environment can be recognized as substances of very high concern (SVHCs) and can include substances which are:

• Carcinogenic, Mutagenic or toxic to Reproduction (CMR),
•  Persistent, Bioaccumulative and Toxic (PBT) or very Persistent and very Bioaccumulative (vPvB)
•  Also, those substances which are identified, on a case-by-case basis, from scientific evidence that causing likely severe effects to human health or the environment (e.g. endocrine disrupters)

When a substance is recognized as SVHC, it will be added to the Candidate List and further eventually it will be included in the Authorisation List.  Following are the substances that are listed and may be included in the Candidate List. Proposals have been sent to submit the comments during the consultation.

The European Chemicals Agency (ECHA), on behalf of the European Commission (EC), is running its fifth project under the Instrument for Pre-Accession Assistance (IPA). These projects are targeted a...

The European Chemicals Agency (ECHA), on behalf of the European Commission (EC), is running its fifth project under the Instrument for Pre-Accession Assistance (IPA). These projects are targeted at assisting European Union (EU) candidate countries to prepare for the obligations of EU membership, in this context specifically regarding chemical safety regulations. They have the overall aim to equip candidate countries with the knowledge necessary to fully participate in the implementation of EU chemicals policy and, in the responsibilities that ECHA shares with MSCAs.

Since 2009, ECHA has implemented four IPA projects focused on explanatory and training events for the authorities of Montenegro and Serbia. The Agency's main goal is to provide technical support to develop these countries’ understanding of ECHA's regulatory activities and facilitate the alignment of their national legislations with the EU regulatory framework.

To increase the impact of ECHA’s general support activities (such as site visits, specific training and participation in ECHA events), the Agency has contracted an in-depth assessment of the legal and institutional capacities of both countries.

The main challenges lie with the limited financial, human and IT resources currently available for the accession countries to implement and enforce the REACH, CLP, BPR and PIC regulations. The study recommends strengthening the administrative capacity of the national authorities, ensuring enough financial resources to implement and enforce the legislation, facilitating cooperation with academia as well as increasing communication activities and IT capacity. 

The national plans outline several actions for Montenegro and Serbia as well as EU Member States and ECHA ahead of a future membership. ECHA stands ready to continue supporting the countries through training and capacity building on risk assessment, IT security and tools, and enforcement.

Last update: 2021-03-31

  Biocidal Products Committee(BPC) is a committee of ECHA which forms opinions on the BPR process and each member state appoints one member fo...

Biocidal Products Committee(BPC) is a committee of ECHA which forms opinions on the BPR process and each member state appoints one member for BPC. Members of BPC meet regularly to discuss and the agenda for those meetings are published 21 days before the meeting.  

In the meeting, BPC proposes not to approve four silver compounds saying that the risks for human health, the product-type 4 (food and feed area) are:

• silver zinc zeolite;
• silver zeolite;
• silver copper zeolite; and
• silver sodium hydrogen zirconium phosphate.

Those substances can be found in kitchen utensils since they are all used to prevent cross-contamination. Also, silver copper zeolite and silver sodium hydrogen zirconium phosphate can be found not only in kitchen utensils but also in water because carbon water filters contain silver zinc zeolite and silver zeolite to prevent bacterial growth and when people use that filtered water to cook or drink, they can be exposed. Consequently, All substances have both commercial and non-commercial applications.  

It is concluded that those substances can’t be used as a disinfectant in food and feed area. For the first time, BPC made a decision considering all the exposure to a substance from many sources not only the use in question.  

Last update: 2021-03-31

The European Commission announced the EU Chemicals Strategy for Sustainability on 14th October 2020, as a key commitment policy to the European Green Deal. The ambition of the European Green Deal ...

The European Commission announced the EU Chemicals Strategy for Sustainability on 14th October 2020, as a key commitment policy to the European Green Deal. The ambition of the European Green Deal is to ensure climate neutrality and circular economy by 2050. The chemical strategy is considered one of the most important parts of the Deal, since it ensures safer environment and health. The strategy is anticipated to have a very large impact on chemical industries related to the EU market.

The European Commission recognises the importance of chemicals for better and higher living standards, however given the hazardous properties of chemicals it has been considered of importance to implement further actions in making chemicals safer and more sustainable. The Strategy’s goals can be divided into two groups:

The goals for increased protection of health and environment, which among others include:

- Phasing out harmful substances form consumer products

- Substituting substances of concern in all products,

- Ensure information access on chemical content and its safe use for producers and consumers.

Goals that boost innovation for safer and more sustainable chemicals, which among others include:

• A financial support in ensuring safe and sustainable-by-design chemicals,
• increase enforcement of EU regulations,
• Simplification and accessibility of EU legal framework by the ‘One substance one assessment' process for the risk and hazard assessment of chemicals
• playing a leading role globally by championing and promoting high standards and not exporting chemicals banned in the EU.

At the Chemical Watch conference “Global Chemicals Management towards 2030 and beyond”, the ECHA Executive Director Bjorn Hansen described the Chemical Strategy as “welcomed by ECHA”. Hansen states that the strategy is anticipated to eliminate regulatory information barriers and enhance the reuse of data collected under different regulations. Furthermore, a more harmonized chemical’s database is expected to greatly facilitate the research processes for scientists in Europe. According to Hansen the Chemical Strategy 2030 is intended to review, revise, and clearly articulate the existing policies and enhance efficiency within the chemical regulatory framework.

The ambitious chemical strategy might lead to a “reopening” of the EU REACH. Some central European countries have expressed their worry regarding the potential “reopening”. Their main concern is that excessive amendments to REACH regulation, in relation to the Chemical Strategy, may lead to pressure on the industries. There are more than 50 action plans laid out to be taken before 2024, as a part of the implementation of the strategy. An introduction of new hazard classes for the CLP Regulation is, for example, expected to be implemented already this year (2021).

The final conclusions regarding the strategy’s implementation are, however, expected to be clarified in March at the next Environment Council meeting. The general support of the strategy by the member states nevertheless predicts a general smooth implementation of the strategy.

Update: 2021-01-29

ECHA has added two new substances to the Candidate List of substances of very high concern (SVHCs) for authorization on 19 January 2021. Now the list contains 211 substances in total. These two...

ECHA has added two new substances to the Candidate List of substances of very high concern (SVHCs) for authorization on 19 January 2021. Now the list contains 211 substances in total.

These two substances were added to the Candidate List as they are toxic for reproduction and hence may adversely affect fertility and cause developmental toxicity in offspring. Both the substances are used in products like inks or toners and also used to produce plastics and rubber tires.

ECHA suggests companies notify ECHA under the Waste Framework Directive (SCIP) if their products contain substances of very high concern.

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

Update: 2021-01-19