ECHA checked whether substances obtained from waste meet the conditions for exempting substance registration under REACH. The obtained results showed that 26% of the substances did not meet the conditions in the scope of:
the identity of the recovered substance with the original one, registered in REACH
the availability of information on safe use
ECHA recommends waste operators to improve their knowledge of the legislation on recovered substances, and to gather information on how the substances will be used by their customers. In addition, national authorities should monitor the situation of recovered substances placed on the market and improve safety for people and the environment.
ECHA recommends including the topic of substance recovery from waste in the scope of the EU-wide enforcement project and the revision of the guide on waste and recovered substances.
Ekotox Center company will help you check whether you are subject to the provisions of the REACH regulation, whether you can use the exemption, or will guide you through the entire registration process.
REACH regulation revision to be postponed till end of 2023
On 18 October 2022, the European Commission adopted its 2023 Commission work programme
REACH revision is postponed to the end of 2023 (legislative, incl. impact assessment, Article 114 TFEU, Q4 2023).
„After consultations with key stakeholders, we will propose a targeted revision of the legislation on the registration, evaluation and authorisation of chemicals (REACH) with the aim of securing European competitive advantages and innovation by promoting sustainable chemicals, simplifying and streamlining the regulatory process, reducing burden and protecting human health and the environment.“
ECHA’s report of REACH authorisation for SVHC substances
Restriction process on certain cobalt compounds terminated
Consultation on new CLP classes finalised
Skin sensitizing substances in consumer mixtures
Reminder to update the safety data sheets
1. Ukrainian’s REACH and CLP
The Cabinet of Ministers approved the Ukrainian chemicals management project. Ukraine will create the legal basis for the introduction of modern European REACH and CLP regulations. In addition, according to the association agreement with the EU, Ukraine has to harmonize its environmental legislation with European legislation and implement the provisions of the Basel Convention, the Rotterdam Convention and the Stockholm Convention on Persistent Organic Pollutants (POP). The proposal will now be submitted to the Ukrainian parliament for approval and implementation.
ECHA has received over 1 000 notifications from industrial sites using chromium trioxide in chrome plating and surface treatment in the EU. This follows two European Commission decisions in December 2020 granting authorisation to use the chemical until September 2024. Enforcement authorities can now carry out inspections as necessary.
By notifying the uses to ECHA, companies confirm that they follow the conditions for use set in the authorisation decisions granted to their suppliers. As part of the conditions, they must inform ECHA by the end of 2021 how their workers are exposed to chromium trioxide. This information will help companies to protect their workers even better by minimising their exposure to the carcinogen.
Majority of downstream users wishing to continue using the chromium trioxide will have to prepare individual application for REACH authorisation.
In fact there is not much of time for preparation of all documents needed for the successful REACH authorisation. Companies should to start asap to complete all required steps in time.
3. ECHA’s report of REACH authorisation for SVHC substances
ECHA has published a report on the use of SVHC substances that are subject to authorization. The study covered the period 2010-2021 and its results show that the use of these substances has decreased by around 45% in the EU. The results confirm that the introduction of an authorization procedure is effective and brings tangible benefits.
4. Restriction process on certain cobalt compounds
The proposed restriction of some cobalt compounds has temporarily not been adopted. According to the April decision, the committee should not prepare amendments to Annex XVII of REACH. However, the Commission asked the RAC for an opinion on the occupational exposure limits to cobalt compounds, due by the end of this year.
Open public consultations on the draft law introducing new hazard classes as part of the revision of the CLP regulation lasted until October 18, in which the committee proposed the need to introduce 3 new hazard classes. The Commission will now assess the comments on the project and start the procedure for adopting the changes.
6. Skin sensitizing substances in consumer mixtures
Open public consultations on the draft legislation introducing new hazard classes as part of the revision of the CLP regulation lasted until October 18. The Commission has proposed the need to introduce 3 new hazard classes. It will now evaluate the comments on the draft and start the procedure for adopting changes.
Once again, we would like to remind you about the upcoming update date of the current safety data sheets. From January 1, 2023, all cards must comply with the new format.
We encourage you to read the current issue of EkotoxInfo chemical news. In the summary of last month you will find the following topics:
Safety Data Sheets 2022 – don’t miss the deadline
Chromium compounds – authorization deadline
Chromium VI authorisation – information sessions for groups of applicants
Biocidal product authorization – be prepared
DDAC – biocidal active substance approval is coming
SIEF Concawe information update
THC impurity limits regulated
Nine proposals to identify new substances of very high concern (SVHC)
New ekotox webinars dates
Safety Data Sheets 2022 – don’t miss the deadline
The European Commission amended Annex II of REACH, concerning the compilation of Safety Data Sheets (SDS): COMMISSION REGULATION (EU) 2020/878 of 18 June 2020, amending Annex II to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH).
31st December 2022 – after this date, all safety data sheets will need to be updated to the new requirements.
The chromium trioxide applications for REACH authorisation by companies is now accelerating. Joint authorisation originally applied by CETAC consortium (and others) will be ineffective after September 2024. Therefore, if the producers that are licensed by the CETAC consortium wish to continue using chromium trioxide, they should take appropriate action now.
There are 2 principal duties for companies using chromium trioxide:
Apply for REACH authorisation in time;
Comply with the conditions comunicated by suppliers through extended safety data sheets and notification to ECHA within 3 months of the first day of delivery.
Chromium VI authorisation – information sessions for groups of applicants
As a high number of authorisation applications are expected for hexavalent chromium (Cr(VI)) uses in the coming years, the way of information sessions for these uses will be changed. In the future, will organised for groups of several applicants. The first group session will take place on 15 February 2023, and more will be organised after that based on need. Future dates will be announced in the bulletin.
The european procedures apply to biocidal products, all active substances of which have been: approved in a given product group (PT), i.e. passed the assessment in the review program, or are included in Annex I to Regulation No. 528/2012, i.e. they are low-risk active substances for human health and the environment. It takes about 2 years to prepare the relevant information, research and registration dossier. In order to keep the product on the market, it is worth starting preparations for registration in new procedures.
DDAC – biocidal active substance approval is coming
There is already a draft Commission Implementing Regulation (EU) approving didecyldimethylammonium chloride as an active substance for use in biocidal products of product groups 1 and 2, in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council. If you sell DDAC products for PT1 PT 2 product groups, you must apply under the new European procedures before the indicated deadline.
Due to the EU sanctions against Russia, which entered into force on June 3, 2022, according to the information provided by the SIEF forum, in order to continue using the SIEF space, an appropriate certificate of commercial compliance must be submitted to 19 September 2022. Details of trade restrictions are included in the Council Implementing Regulation (EU) 2022/878.
European Commission announced maximum THC contamination limits in foodstuffs for hemp seed, partially ground hemp seed, and also for oil. The entry for delta-9-tetrahydrocannabinol equivalents has also been added. The regulation comes into force on January 1, 2023.
There are new webinar dates for 2022 on the Ekotox website. Ekotox Centers also organize training courses on request, dedicated to the needs of a given company. Please visit our website!
Ukraine’s cabinet of ministers has approved a draft law that, if adopted, would see the creation of a national chemicals management framework, with significant obligations for industry. The draft law, approved on 13 September, would see the introduction of:
-mandatory registration of all chemical substances;
-a system for classifying hazardous substances;
-restricting and banning the use of particularly hazardous substances;
-and obligations for business.
The proposed law would help protect the environment from pollution, as well as reduce the level of diseases associated with exposure to hazardous chemicals, Ukraine’s cabinet of ministers said in a press release.
Business entities will receive “clear rules” harmonised with international and European standards. “This will facilitate their access to foreign markets,” it added.
Industry obligations
Among other obligations, the draft law would require “business entities” to:
-comply with requirements regarding the registration of substances and the safe handling of chemical products;
-carry out an assessment of a chemical’s safety;
-provide information about “dangerous” substances, chemical incidents and cases of environmental pollution;
-introduce a system of chemical safety and chemical product management based on a risk-oriented approach;
-carry out hazard classification of chemical products and identification of hazardous substances; and
-carry out a risk assessment of the level of danger to the environment and the health of the population during the production and use of chemical products, including during use in scientific-technical and research-technological developments, and the production of new substances.
EU candidate
The draft law would also implement the provisions of the Basel Convention, Rotterdam Convention and Stockholm Convention on persistent organic pollutants (POPs).
The draft law will now head to Ukraine’s parliament for consideration.
Earlier this month, Ukraine adopted a law prohibiting the production and use of all asbestos and asbestos-containing products and materials. It also proposed to restrict the use of the antibacterial chemical, triclosan, in food contact materials in a draft Regulation that is open for consultation.
ECHA is looking for comments on nine proposals to identify new substances of very high concern. Give comments by 17 October 2022.
Helsinki, 7 September 2022 – The substances and examples of their uses are:
4,4′-sulphonyldiphenol (bisphenol S; BPS) (EC 201-250-5, CAS 80-09-1). Used for the manufacture of pulp, paper and paper products, textile, leather or fur, and chemicals.
Melamine (EC 203-615-4, CAS 108-78-1). Used in polymers and resins, coating products, adhesives and sealants, leather treatment products, and laboratory chemicals.
Isobutyl 4-hydroxybenzoate (EC 224-208-8, CAS 4247-02-3). Used in the manufacture of substances and in coating products, fillers, putties, plasters, modelling clay, and inks and toners.
As a high number of authorisation applications are expected for hexavalent chromium (Cr(VI)) uses in the coming years, the way of information sessions for these uses will be changed. In the future, will organised for groups of several applicants.
The first group session will take place on 15 February 2023, and more will be organised after that based on need. Future dates will be announced in the bulletin.
Safety Data Sheets (SDS) are documents for communicating information on the hazards of chemicals and mixtures and the risks they pose to human health and the environment.
The European Commission amended Annex II of REACH, concerning the compilation of Safety Data Sheets (SDS):
COMMISSION REGULATION (EU) 2020/878 of 18 June 2020, amending Annex II to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH).
31st December 2022 – after this date, all safety data sheets will need to be updated to the new requirements.
The new requirements include:
Alignment of SDS with the UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS) Revisions 7 and 8;
Inclusion of Unique Formula Identifiers (UFIs) to Section 1 (in line with Regulation (EU) 2017/542);
Additional information requirements for substances placed on the market as a nanoform (in line with Regulation (EU) 2018/1881) and for substances and mixtures with endocrine-disrupting properties;
Addition of the Specific Concentration Limits (SCLs), multiplying factors and acute toxicity estimates (ATE), if available, set in accordance with CLP 1272/2008.
The main sections of the SDS which have undergone revision are 1, 2, 3, 9, 11 and 12.
Chromium trioxide (EC No. 215-607-8; CAS No. 1333-82-0) is widely used in plating and surface treatment.
Notifications from 1 026 sites across Europe submitted by May 2021. confirm that chromium trioxide is still widely used in functional or hard chrome plating and surface treatment. The annual usage is estimated to be 7 000 tonnes. The substance of very high concern was placed on the Authorisation List in 2013 and its use has needed a specific authorisation in the EU since 2017.
By notifying the uses to ECHA, companies confirm that they follow the conditions for use set in the authorisation decisions granted to their suppliers. As part of the conditions, they must inform ECHA by the end of 2021 how their workers are exposed to chromium trioxide. This information will help companies to protect their workers even better by minimising their exposure to the carcinogen.
In December 2020 European Commission published 2 decisions granting authorisation to use the chemical until September 2024.
Enforcement authorities can now carry out inspections as necessary.
There are 2 principal duties for companies using chromium trioxide:
Apply for REACH authorisation in time;
Comply with the conditions comunicated by suppliers through extended safety data sheets.
The chromium trioxide applications for REACH authorisation by companies is now accelerating.
Joint authorisation originally applied by CETAC consortium (and others) will be ineffective after September 2024.
Ekotox Centers offer complex services to prepare all necessary documents on behalf of the customers. To stay on the market there is need for immediate action!
On the same time there is a duty to comply with the safety measures and operational conditions – requirements defined for downstream users by eSDS. To be sure that all is in compliance Ekotox Centers provide support to manage „Internal Dossiers for REACH Authorisation Compliance“ (IDRAC).
We encourage you to read the current issue of EkotoxInfo chemical news. In the summary of last month you will find the following topics:
DDAC – biocidal active substance approval is coming
Legal procedure for implementing changes to the CLP Regulation
Update of the Blue Guide
Skin sensitizing substances in consumer mixtures
SSbD – Safe and sustainable design
New concerning the authorisation of biocidal products
News on cosmetic products
DDAC – biocidal active substance approval is coming
There is already a draft Commission Implementing Regulation (EU) approving didecyldimethylammonium chloride as an active substance for use in biocidal products of product groups 1 and 2, in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council. If you sell DDAC products for PT1 PT 2 product groups, you must apply under the new European procedures before the indicated deadline.
Legal procedure for implementing changes to the CLP Regulation
The last meeting raised the question of whether the European Commission has the power to adopt amendments under the current CLP legislation. The Commission plans to adopt some changes to its mandate under the CLP revision by means of a delegated act without the involvement of the European Parliament.
The European Commission has published an update of the Blue Guide, which provides information on the implementation of EU product rules and their implementation on the European market. The guide aims to better understand EU rules on products and to facilitate their uniform application in all sectors across the single market.
France, Ireland and Germany invite interested parties to submit information on skin sensitisers in mixtures intended for consumers. Deadline for data delivery: 30/09/2022.
The JRC technical report has been published. “Safe and sustainable design of chemicals and materials” containing a framework of criteria and definitions for the safety assessment of chemicals and materials.
New concerning the authorisation of biocidal products
Germany has requested the European Commission to approve the authorisation for the biocidal product group L+R Propanol PT1 Family for professional use only. The evaluating country was Switzerland. L+R Propanol PT1 Family contains propane-1-ol and propane-2-ol as active substances which are included in the Union list of approved active substances pursuant to Article 9(2) of Regulation (EU) No 528/2012 for product-type 1. The authorisation for PT 1 (Human personal care) has been granted until 30 June 2032.
Belgium has requested the European Commission to approve the authorisation for the Contec Hydrogen Peroxide Biocidal Product Family for professional use only. The evaluating country was Slovenia. Contec Hydrogen Peroxide Biocidal Product Family contains hydrogen peroxide as an active substance which is included in the Union list of approved active substances under Article 9(2) of Regulation (EU) No 528/2012 for product type 2 . The authorisation for PT 2 (Disinfectants and algaecides not intended for direct application to humans or animals) has been granted until 30 June 2032.
Germany has requested the European Commission to approve the authorisation of the biocidal product Bioquell HPV-AQ for professional use only. The Netherlands was the evaluating country. Bioquell HPV-AQ contains hydrogen peroxide as an active substance which is included in the list of approved active substances
Union’s list of approved active substances under Article 9(2) of Regulation (EU) No 528/2012 for product types 2, 3 and 4. Authorisations for PT2 (Disinfectants and algaecides not intended for direct application to humans or animals), PT 3 (Veterinary hygiene) and PT 4 (Food and feed area) were granted until 31 July 2032.
Belgium has requested the European Commission to approve the authorisation for INTEROX Biocidal Product Family 1 for professional use only. The evaluating country was Finland. INTEROX Biocidal Product Family 1 contains hydrogen peroxide as an active substance, as an active substance included in the Union list of approved active substances under Article 9(2) of Regulation (EU) No 528/2012 for product types 2, 3 and 4. Authorisations for PT2 (Disinfectants and algicides not intended for direct application to humans or animals), PT 3 (Veterinary hygiene) and PT 4 (Food and feed area) were granted until 30 July 2032.
Germany has requested the European Commission to approve the authorisation for the Knieler & Team Propanol Family of biocidal products for industrial and professional use. The evaluating country was Switzerland. Knieler & Team Propanol Family contains propane-1-ol and propane-2-ol as active. substances which are included in the Union list of approved. active substances pursuant to Article 9(2) of Regulation (EU) No 528/2012 for product types 1, 2 and 4. Authorisations for PT 1 (Human personal care), PT 2 (Disinfectants and algicides not intended for direct application to humans or animals) and PT 4 (Food and feed area) were granted until 31 July 2032.
Commission Regulation (EU) 2022/1181 regulates the threshold for formaldehyde-releasing substances as a preservative in both non-washable and washable cosmetic products.
The use of formaldehyde is prohibited in cosmetic products due to its classification as a carcinogen (category 1B). Annex V to Regulation (EC) No 1223/2009 lists the substances that are allowed to be used as preservatives in cosmetic products. Some of the substances listed release formaldehyde gradually to perform the function of preservative in the final cosmetic product. In order to inform formaldehyde-sensitive consumers about the presence of formaldehyde, which can cause an allergic reaction, a threshold of 0,05 % (500 ppm) is set in the finished product and the product must be labelled with a specific warning ‘contains formaldehyde’.
The Scientific Committee on Consumer Safety concluded that the current threshold does not sufficiently protect. formaldehyde-sensitive consumers and therefore proposed to lower the current threshold. to 0.001% (10 ppm), regardless of whether the product contains one or more formaldehyde-releasing substances.
All finished products containing formaldehyde-releasing substances that comply. with the requirements of Regulation (EC) No 1223/2009. as applicable from 30 July 2022 may be placed on the Union market until 31 July 2024 and may. be made available on the Union. market until 31 July 2026.
Commission Regulation (EU) 2022/1176, based on the opinion of the Scientific Committee. on Consumer Safety, tightens the concentrations for Benzophenone-3 and Octocrylene used. as UV filters in cosmetic products due to their properties as potential endocrine disruptors.
The substance Benzophenone-3 is safe for the consumer when used as a UV filter:
in concentrations up to 2.2 %: Cosmetic body products including in aerosol spray and pump spray form
in concentrations up to 6 %: Cosmetic products for face, hands and lips, excluding aerosol spray and pump spray products
When used at a concentration of 0,5 % to protect. the composition of the product, the content used as a UV filter shall not exceed 1,7 %.
The substance Octocrylene is safe for the consumer when used as a UV filter:
at a concentration of up to 10 % alone
in concentrations up to 10 %: Cosmetic products for face, hand and lip, except aerosol spray and pump spray products
in concentrations up to 9 %: Aerosol spray products
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