In 2016, the competent French authority submitted to the European Chemicals Agency. a proposal to classify titanium dioxide as a carcinogenic substance. The following year, EU Commission adopted Regulation 2020/2017 (14 ATP to CLP) as a consequence of RAC opinion. classifying titanium dioxide as a category 2 carcinogen.
Chemical entities brought actions before the General Court for the partial annulment of Regulation 2020/217. In the judgment, the Court annuls the contested regulation in so far as it concerns the harmonised classification and labelling of titanium dioxide. in the form of a powder with 1% or more of particles with an aerodynamic diameter not exceeding 10 μm.
The General Court recognised that RAC committed. a manifest error of the assessment and found that the contested classification and labelling infringed the criterion according to which the classification of a substance as carcinogenic can apply only to a substance that has the intrinsic property to cause cancer.
This decision is very important for the industry, because titanium dioxide is commonly used in the production of paints and coatings, plastics, paper, as well as in the cosmetics industry for sunscreen cosmetics. It can be found in paper, cosmetics, medicines, medical supplies and food products.
We encourage you to read the current issue of EkotoxInfo chemical news. In the summary of last month you will find the following topics:
One in four substances recovered from waste non-compliant with REACH
Restriction proposals for bisphenols and creosote available
Assessment of regulatory needs reports published
Restriction process on certain cobalt compounds terminated
Consultation on new CLP classes finalised
Skin sensitizing substances in consumer mixtures
Control program of imported substances and products in 2023-2025
SCIP database available in EEA countries
Revision of REACH regulation to be postponed
Cosmetics – changes in the cosmetics ingredients
The European Commission has published guidelines for safe chemicals
Community rolling action plan for 2021-2023
A new list of allergens in cosmetics in 2023
Guidance on the Biocidal Products efficacy has been updated
Reminder to update the safety data sheets
One in four substances recovered from waste non-compliant with REACH
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;
Restriction proposals for bisphenols and creosote available
Restriction proposals published for:
4,4′-isopropylidenediphenol (bisphenol A) as well as other bisphenols and bisphenol derivatives with endocrine-disrupting properties for the environment, prepared by Germany;
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.
Denmark, France, Germany and Ireland were requesting interested parties to submit information related to skin sensitising substances in consumer mixtures. The information gathered will be used to assess the need for regulatory actions on skin sensitisers in consumer mixtures.
This call for evidence consultation has been extended until 31 October 2022.
Control program of imported substances and products in 2023-2025
The inspections are planned for 2023-2025 and involve the national authorities of the Member States. The project will also work on further developing and strengthening the existing cooperation between REACH inspectors and customs authorities.
From 7 November, companies from Iceland, Liechtenstein and Norway can submit notifications on their products containing substances of very high concern to ECHA. We remind you, that for EU countries, the duty to submit SCIP notifications started in January 2021.
On October 18, 2022, the European Commission adopted the Commission’s Work Program for 2023, postponing the revision of the REACH Regulation to the end of 2023.
On November 10, the European Commission published a new regulation amending the annexes to the Cosmetics Regulation. This regulation shall enter into force on the twentieth day following its publication – 01.12.2022.
The European Commission has published guidelines for safe chemicals
The Strategic Research and Innovation Plan for Chemicals (SRIP) sets out a roadmap to the European Green Deal and highlights the key areas of research and innovation responsible for creating safe and sustainable chemicals and materials.
The Community rolling action plan identifies priority substances for evaluation to address concerns about possible risks to human health or the environment from the manufacture or use of these substances. The assessment may lead to the inclusion of a substance e.g. on the CMR, ED, PBT list and regulate their further use.
The amendment to the Cosmetics Regulation extends the list of allergenic substances. The project is already prepared and its publication is planned at the turn of the first / second quarter of 2023.
Guidance on the Biocidal Products efficacy has been updated
The guidance document for the Biocidal Products Regulation (BPR) Volume II – Efficacy Assessment and Evaluation (Parts B+C) has been updated. The update covers the chapter on disinfectants for product-types 1-5. Appendices 1-4 have also been updated based on recently developed and published European standards.
Once again, we would like to remind you about the upcoming update date of the current safety data sheets. From January 1, 2023, all safet data sheets must comply with the new format.
EKOTOX CENTERS specializes in authoring of safety data sheets based on the requirements of the CLP and REACH Regulations + additional requirements of the EU member state. The documents must be drawn up by a competent person with appropriate knowledge and training, taking into account specific requirements of the respective EU Member State starting including languages, occupational limit values, national toxicological centre notification and more.
But, be careful, just „translation” of a safety data sheet document drawn up by an ordinary translator who has no knowledge of chemicals legislation could not be in compliance due to specific legal terms so it is often drawn up by translations that are too literal, erroneous and not in accordance with the European guidelines for drawing up safety data sheets. More to that, safety data sheet is today more complex and so multidisciplinary team will definitely be of an advantage.
Our specialists have many years of experience and daily working on different aspects of EU chemicals legislation, including: classification of chemical substances and mixtures, assigning H and P phrases, rules of labelling and packaging of substances and mixtures, notifications in the Poison Centre, assigning UFI codes, advising in labelling, managing the safety of documentation.
Language(s) in which the SDS must be provided:
According to REACH Article 31(5), “The safety data sheet shall be supplied in an official language of the Member State(s) where the substance or mixture is placed on the market, unless the Member State(s) concerned provide otherwise”.
It should be noted that it is for the recipient Member State (MS) to provide otherwise – i.e. for example the existence of an exemption in the MS of manufacture does not give an exemption in a different MS where the substance or mixture is placed on the market. Even if the MS provides otherwise, it may be desirable to always provide (potentially in addition) the SDS in the language of the country.
It should be noted that certain Member States require that the SDS be provided in additional official MS languages (of that MS, where there is more than one official language).
It should also be noted that as the annexed exposure scenario is considered to be an integral part of the SDS it is subject to the same translation requirements as the SDS itself – i.e. it must be supplied in an official language of the Member State(s) where the substance or mixture is placed on the market, unless the recipient Member State(s) concerned provide otherwise.
SDS – New requirements 2022
Amendments and modifications to the REACH and CLP regulation are gradually introducing increased requirements for the format and content of the SDS. It requires companies to plan an implementation process to ensure compliance with legislative requirements.
SDS changes:
Each supplier of chemical mixtures must fulfil obligations under Article 31 of REACH (Requirements for safety data sheets) and Annex II of REACH regulation. The references to the legal text have been updated to reflect the latest version of Annex II (i.e. the Annex to Regulation (EU) 2020/878).
The Commission Regulation (EU) 2020/878 introduces changes in the scope of:
– new requirements for nanoforms of substances, adapting to the 6th and 7th revision of the GHS, and adding requirements regarding the Unique Formula Identifier (as set by Annex VIII to Regulation (EC) 1272/2008), endocrine disrupting properties, specific concentration limits, M-factors and acute toxicity estimates…
The document provides for changes in the provisions and the format of the safety data sheet. The most important changes include:
– new format for section 9;
– separation of a new subsection 11.2;
– separation of new subsections 12.6 and 12.7;
– the wording of the subsection has been changed in sections 14.1 and 14.7;
Countries and languages of SDSs:
EKOTOX CENTERS offer SDS authoring for a wide range EU member states and other countries, basically in the following languages:
EU countries
Austria – German;
Belgium – French/German/Dutch;
Bulgaria – Bulgarian;
Croatia – Croatian;
Cyprus – Greek;
Czech Republic – Czech;
Denmark – Danish;
Estonia – Estonian;
Finland – Finnish;
France – French;
Germany – German;
Greece – Greek;
Hungary – Hungarian;
Iceland – Icelandic;
Italy – Italian;
Latvia – Latvian;
Lichtenstein – German;
Lithuania – Lithuanian;
Luxemburg – French;
Malta – English;
Netherlands – Dutch;
Norway – Norwegian;
Poland – Polish;
Portugal – Portuguese;
Romania – Romanian;
Slovakia – Slovak;
Slovenia – Slovenian;
Spain – Spanish;
Sweden – Swedish;
NON-EU countries
Switzerland – German/English/Italy/France;
United Kingdom and Ireland – English;
Ukraine – Ukrainian.
If you have not found the appropriate country / language above, please contact us for an individual assessment of the possibility of preparing a required document.
At its last meeting in November, the Enforcement Forum. agreed on a follow-up project to investigate whether companies are complying with. REACH obligations for products imported from outside the EU. Inspections will check the enforcement of regulations for the import of substances, chemical mixtures and articles.
The inspections are planned for 2023-2025 and involve the national authorities of the Member States. The project will also work on further developing and strengthening the existing cooperation between REACH inspectors and customs authorities.
Previous results showed that 23% of the imported products checked were non-compliant with the requirements set out in EU law, so ECHA decided to take appropriate action.
On November 10, the European Commission published a new regulation amending the annexes to the Cosmetics Regulation. The change concerns:
– limitation Butylated Hydroxytoluene (BHT) to a maximum concentration of 0.001% in mouthwash, 0.1% toothpaste and 0.8% in other rinse-off and leave-on products
– limitation of Acid Yellow 3 to 0.5% in non-oxidative hair dye products
– limitation of Homosalate ingredient to 7.43% for face products
– Bis-(Diethylaminohydroxybenzoyl Benzoyl) Piperazine and its nano form – maximum concentration up to 10% and limitation in inhalation exposure
This regulation shall enter into force on the twentieth day following its publication – 01.12.2022.
COMMISSION REGULATION (EU) 2022/2195
of 10 November 2022
amending Regulation (EC) No 1223/2009 of the European Parliament and of the Council as regards the use of Butylated Hydroxytoluene, Acid Yellow 3, Homosalate and HAA299 in cosmetic products and correcting that Regulation as regards the use of Resorcinol in cosmetic products.
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.
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