COMMISSION REGULATION (EU) 2020/1682 of 12 November 2020 amending Annex III to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32020R1682&from=EN

Cases of sensitisation to nail products containing HEMA and Di-HEMA TMHDC reported in some Member States lead the Commission to the conclusion that there is a risk that such products may be applied with insufficient precision, causing contact with the skin adjacent to the nail plate.

Cosmetic products containing HEMA or di-HEMA TMHDC

From 3 June 2021 products containing that substance and not complying with those conditions shall not be placed on the Union market.

From 3 September 2021 products containing that substance and not complying with those conditions shall not be made available on the Union market.

Wording of conditions of use and warnings:

For professional use only

Can cause an allergic reaction

EU Cosmetics Legislation and Requirements

Support and assistance by Ekotox experts for EU and non-EU producers and importers

https://ekotox.com.ua/cosmetics/

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EKOTOX CENTERS

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 Ekotoxikologické centrum CZ
Centrum Ekotoksykologiczne (PL)
Ekotoxikologické centrum Bratislava, s.r.o. (SK)

Tomášikova 10/F, 821 03 Bratislava
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September 28

ECHA’s Enforcement Forum

https://echa.europa.eu/sk/-/1-in-4-imported-products-found-to-be-non-compliant-with-reach-and-clp

Helsinki, 24 September 2020 – National enforcement authorities and customs inspectors in 16 Member States checked almost 1 400 products, with more than 300 (23 %) found to be non-compliant with certain obligations under REACH and the Classification, Labelling and Packaging (CLP) regulations. The products were checked at strategic entry points in these countries, such as airports and harbours but also at inland customs offices.

The majority of checks addressed compliance with REACH restriction obligations, focusing on the presence of the restricted substances cadmium, lead and nickel in articles. Of the 1 225 checks for restricted substances, 17 % of the products had amounts of the restricted substances above the required limit. This rate is similar to those reported in the Forum’s previous project on restrictions (REF-4) conducted in 2016. The highest rate of non-compliance was for cadmium detected in jewellery.

The majority of the products were checked for restriction obligations (79 %) and those found to be non-compliant (74 %) mostly came from China, as well as from the United Arab Emirates, India, Thailand, North Macedonia and Madagascar. Importers of articles containing chemical substances must ensure that products placed on the EU market are compliant with REACH obligations.

https://echa.europa.eu/documents/10162/13555/customs2_project_report_en.pdf/5a2c3795-7ed9-5900-fe28-540228abc7c1

Under this pilot project, cooperation with the customs authorities for better enforcement of the REACH and CLP regulations has been examined. Selected controls were performed on products before they enter the European Single Market. These products were mostly:

(a) articles for which the presence of a substance restricted by REACH Annex XVII was checked, for example jewellery and other metal and plastic articles; and

(b) mixtures, for which the classification and packaging requirements were examined.

The primary scope of this project was to check the compliance of imported goods during the time when they were still under customs supervision and to prohibit the entrance of non-compliant products to the European market.

Products, goods and articles – EU legal defnition and requirements on Ekotox webpages:

https://ekotox.com.ua/articles/

EU Cosmetics Legislation and Requirements

Support and assistance by Ekotox experts for EU and non-EU producers and importers

https://ekotox.com.ua/cosmetics/

Actual Ekotox webinars: https://reachtraining.eu/en/seminars

EKOTOX CENTERS

• Legislation and Regulatory Compliance Services (EU REACH, CLP, detergents, RoHS, WEEE, POPs…)
• Safety Data Sheets and products/mixtures registration on the EU member states markets (Poison Centers), UFI and more
• Biocides
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• Chemicals risk assessment / management
• Environmental Health & Safety & Risk Assessment
• Occupational Health & Safety & Risk Assessment

 Ekotoxikologické centrum CZ
Centrum Ekotoksykologiczne (PL)
Ekotoxikologické centrum Bratislava, s.r.o. (SK)

Tomášikova 10/F, 821 03 Bratislava
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ECHA Board of Appeal Helsinki, 18 August 2020

https://echa.europa.eu/about-us/who-we-are/board-of-appeal

The Board of Appeal found that the REACH Regulation requires registrants to perform studies on vertebrate animals even if the substance is used exclusively as an ingredient in cosmetic products. The REACH Regulation does not contain an automatic exemption from the information requirements for registration if a substance is used as an ingredient in cosmetic products. A registrant can benefit from an exemption only if it shows that the conditions for an adaptation (for example, a waiver for the studies) are fulfilled.

This conclusion is consistent with the Cosmetics Regulation. The Cosmetics Regulation contains restrictions for vertebrate animal testing on the ingredients of cosmetic products. These restrictions, however, do not prevent registrants from carrying out tests in order to comply with the information requirements of REACH.

https://echa.europa.eu/documents/10162/23010712/a-009-2018_decision_en.pdf/237e31c9-2801-c160-7e5b-7ce81a3b7f17

EU Cosmetics Legislation and Requirements

Support and assistance by Ekotox experts for EU and non-EU producers and importers

https://ekotox.com.ua/cosmetics/

Actual Ekotox webinars: https://reachtraining.eu/en/seminars

EKOTOX CENTERS

• Legislation and Regulatory Compliance Services (EU REACH, CLP, detergents, RoHS, WEEE, POPs…)
• Safety Data Sheets and products/mixtures registration on the EU member states markets (Poison Centers), UFI and more
• Biocides
• Cosmetics Safety
• Chemicals risk assessment / management
• Environmental Health & Safety & Risk Assessment
• Occupational Health & Safety & Risk Assessment

 Ekotoxikologické centrum CZ
Centrum Ekotoksykologiczne (PL)
Ekotoxikologické centrum Bratislava, s.r.o. (SK)

Tomášikova 10/F, 821 03 Bratislava
Slovenská republika
Tel.: +421 (2) 4594 3712, 4594 5223
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ECHA/NR/20/26

Exporters of the substances now have to notify their designated national authority before exporting them. In most cases, consent from the importing country is also needed. In addition, exports from the EU of a series of mercury-containing articles, such as fluorescent lamps, have also been banned.

https://echa.europa.eu/-/22-hazardous-chemicals-added-to-eu-regulation-on-imports-and-exports

19 new entries containing 22 substances are now subject to export notifications under the PIC Regulation. Three of the entries (diquat, glufosinate and propineb) cover two substances each.

EU exporters who want to export any of the substances after 1 September 2020, as such or in mixtures, need to notify their designated national authority of their intention at least 35 days before the date of their first export.

20 of the 22 substances also need consent from the authorities of the importing country before they can be exported.

The majority of the 22 substances have been added to the PIC Regulation because they are banned as active substances in plant protection products within the EU. Some are also severely restricted under the Biocidal Products Regulation and, approved only for a limited number of biocidal products. One substance (imidacloprid) is also used in veterinary medicinal products.

COMMISSION DELEGATED REGULATION (EU) 2020/1068 of 15 May 2020

amending Annexes I and V to Regulation (EU) No 649/2012 of the European Parliament and of the Council concerning the export and import of hazardous chemicals

https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32020R1068&from=EN

Annex I to Regulation (EU) No 649/2012 is amended by these substances:

(1) in Part 1, in the table, the following entries are added:

in Part 3, in the table, the following entries are added:

In Annex V to Regulation (EU) No 649/2012, the table of Part 2 is amended as follows: (1) in entry 3, the following text is added:

(2) the following entries are added:

REGULATION (EU) No 649/2012 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 4 July 2012 concerning the export and import of hazardous chemicals

https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32012R0649&from=EN

Actual Ekotox webinars: https://reachtraining.eu/en/seminars

EKOTOX CENTERS

• Legislation and Regulatory Compliance Services (EU REACH, CLP, detergents, RoHS, WEEE, POPs…)
• Safety Data Sheets and products/mixtures registration on the EU member states markets (Poison Centers), UFI and more
• Biocides
• Cosmetics Safety
• Chemicals risk assessment / management
• Environmental Health & Safety & Risk Assessment
• Occupational Health & Safety & Risk Assessment

 Ekotoxikologické centrum CZ
Centrum Ekotoksykologiczne (PL)
Ekotoxikologické centrum Bratislava, s.r.o. (SK)

Tomášikova 10/F, 821 03 Bratislava
Slovenská republika
Tel.: +421 (2) 4594 3712, 4594 5223
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Substances of concern: PAHs, furans, dioxins, PCBs and formaldehyde

ECHA original article link: https://newsletter.echa.europa.eu/home/-/newsletter/entry/keeping-harmful-chemicals-out-of-baby-nappies

The French Agency for Food, Environmental and Occupation Health & Safety (Anses) published in January 2019 the study on baby nappies using the results of tests performed by two different laboratories to check 23 products available on the French market to see if wearing baby nappies can be associated with negative health effects,”.

The risk assessment was based on the laboratory test results and the available literature data. Based on this analysis, could be seen that health thresholds were exceeded for PAHs, furans, dioxins and PCBs and for the sums of these chemicals.

Most of the hazardous chemicals found in baby nappies are considered contaminants because only perfumes and fragrances are intentionally added.

To be able to prepare the restriction proposal, Anses needs more information – the call for evidence is running until 31 March 2020.

Evidence to be gathered covers, for example:

• the scope of the restriction proposal – types of baby nappies and information about the substances included in the scope;
• exposure assessment – babies’ exposure to substances, use of single-use nappies in different EU countries;
• concentration limits and analytical methods – information about standardised methods for testing;
• alternatives – considering the substances are not intentionally added but contaminants or residues; and
• socio-economic impact of a possible restriction – taking into account the costs and benefits for all affected actors.

The restriction dossier is expected to be submitted in October 2020.

More information – REACH Restrictions on Ekotox: https://ekotox.com.ua/restrictions/

Actual Ekotox webinars: https://reachtraining.eu/en/seminars

EKOTOX CENTERS

• Legislation and Regulatory Compliance Services (EU REACH, CLP, detergents, RoHS, WEEE, POPs…)
• Safety Data Sheets and products/mixtures registration on the EU member states markets (Poison Centers), UFI and more
• Biocides
• Cosmetics Safety
• Chemicals risk assessment / management
• Environmental Health & Safety & Risk Assessment
• Occupational Health & Safety & Risk Assessment

 Ekotoxikologické centrum CZ
Centrum Ekotoksykologiczne (PL)
Ekotoxikologické centrum Bratislava, s.r.o. (SK)

Tomášikova 10/F, 821 03 Bratislava
Slovenská republika
Tel.: +421 (2) 4594 3712, 4594 5223
E-mail: ekotox(at)ekotox.eu

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Ecotox Centers are offering consultation services focused on REACH legislation, Management of SVHC substances, communication in supply chain and support for EU chemicals legislation compliance.

 We do have done several projects in terms of:

• REACH Authorisation applications – development of whole REACH Authorisation documentation.
• Downstream users compliance – Internal Documentation for REACH Authorisation Compliance (IDRAC).

 If you have questions please contact us:
phone +421 2 45943712 / e-mail ekotox(at)ekotox.eu

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https://echa.europa.eu/authorisation-list

EKOTOX CENTERS

Ekotoxikologické centrum CZ

Centrum Ekotoksykologiczne (PL)

Ekotoxikologické centrum Bratislava, s.r.o. (SK)

Tomášikova 10/F, 821 03 Bratislava

Slovenská republika

Tel.: +421 (2) 4594 3712, 4594 5223

E-mail: ekotox(at)ekotox.eu

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From April 2020, ECHA will check that use and exposure information as well as risk characterisation is included in chemical safety report (CSR) for registered chemicals.

ECHA link: https://newsletter.echa.europa.eu/home/-/newsletter/entry/make-sure-your-chemical-safety-report-is-complete-we-ll-start-to-check-in-april

The checks of the chemical safety report will be based on the uses reported in registration dossiers.

ECHA will be checking the completeness of chemical safety reports for any registrations where the substance tonnage band is more than 10 tonnes per year and the substance is classified as hazardous to the environment or human health, or has persistent, bioaccumulative and toxic properties. The registration dossier will not be checked for the CSR in case that company is part of a joint submission and so rely on the chemical safety report submitted in the lead registrant dossier.

The new checks on the chemical safety report will only verify that the required elements are present and will not look at the adequacy of the information submitted. The checks will be carried out for both initial dossiers and their updates.

If the chemical safety report cannot be opened or is written in a language other than one of the official EU languages, it will be considered incomplete and CSR submission will fail.

There will be some changes to the computer-based completeness checks, too. To make sure that the standard information requirements described in REACH Articles VII-X are met, ECHA is improving the way the elements for key hazard endpoints are checked. More explicit checks will be carried out for the following endpoints: mutagenicity, reproductive toxicity and degradation.

Information related to the substance life cycle will also be checked as part of the computer-based verification. This means that the checks will detect if, based on the use description, the registration should also include information about article service life.

Since these changes will become part of the computerised checks, they will also be included in the updated IUCLID Validation assistant which is recommended to be used before submitting the data to ECHA.

The improved completeness check will start to apply at the end of April following the release of a new version of IUCLID.

More information – REACH Registration on Ekotox: https://ekotox.com.ua/reach-registration/

Actual Ekotox webinars: https://reachtraining.eu/en/seminars

EKOTOX CENTERS

• Legislation and Regulatory Compliance Services (EU REACH, CLP, detergents, RoHS, WEEE, POPs…)
• Safety Data Sheets and products/mixtures registration on the EU member states markets (Poison Centers), UFI and more
• Biocides
• Cosmetics Safety
• Chemicals risk assessment / management
• Environmental Health & Safety & Risk Assessment
• Occupational Health & Safety & Risk Assessment

 Ekotoxikologické centrum CZ
Centrum Ekotoksykologiczne (PL)
Ekotoxikologické centrum Bratislava, s.r.o. (SK)

Tomášikova 10/F, 821 03 Bratislava
Slovenská republika
Tel.: +421 (2) 4594 3712, 4594 5223
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The European Commission has adopted its Regulation to add 11 SVHCs to Annex XIV – the REACH authorisation list.

eur-lex.europa link: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX%3A32020R0171&from=GA&fbclid=IwAR1saipCr3iJX-V4h3sds6CP23U5H9TsGoXsbzj4eoW5fe_v648HXGOTLE0

The regulation for their inclusion was published in February 6, 2020 – COMMISSION REGULATION (EU) 2020/171. Their addition to the authorisation list increases the number of substances in the Annex XIV from 43 to 54.

Background

The authorisation process aims to ensure that substances of very high concern (SVHCs) are progressively replaced by less dangerous substances or technologies where technically and economically feasible alternatives are available.

The route to authorisation starts when a Member State or ECHA, at the request of the Commission, proposes a substance to be identified as an SVHC.More on obligations in terms of SVHCs on Ekotox: https://ekotox.com.ua/substances-of-very-high-concern-svhc/

The authorisation process is described in the scheme below:

Link to ECHA: https://echa.europa.eu/substances-of-potential-concern

Substances included in the Authorisation List on 6 February 2020 and their SVHC properties:

More information – REACH authorisation process on Ekotox: https://ekotox.com.ua/reach-authorisation/

Actual Ekotox webinars: https://reachtraining.eu/en/seminars

EKOTOX CENTERS

• Legislation and Regulatory Compliance Services (EU REACH, CLP, detergents, RoHS, WEEE, POPs…)
• Safety Data Sheets and products/mixtures registration on the EU member states markets (Poison Centers), UFI and more
• Biocides
• Cosmetics Safety
• Chemicals risk assessment / management
• Environmental Health & Safety & Risk Assessment
• Occupational Health & Safety & Risk Assessment

 Ekotoxikologické centrum CZ
Centrum Ekotoksykologiczne (PL)
Ekotoxikologické centrum Bratislava, s.r.o. (SK)

Tomášikova 10/F, 821 03 Bratislava
Slovenská republika
Tel.: +421 (2) 4594 3712, 4594 5223
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ECHA will soon verify the size of micro, small and medium-sized companies (SMEs) that have registered substances between 2016 and 2019 under REACH and benefitted from reduced fees. Check that you declared your enterprise’s size correctly and have uploaded the documents in REACH-IT.

SME registrant should check that the enterprise size claimed when registering or updating REACH registration is correct and that the required support documents in REACH-IT are correctly uploaded.

In case of enterprise size claimed turns out to be incorrect, ECHA should be informed by sending an email to: sme-verification@echa.europa.eu by 11 February 2020 information in REACH-IT should be updated.

By declaring and rectifying company size before ECHA begins the verification check, registrant will benefit from a full administrative charge waiver and only have to pay the difference to the applicable registration fee.

If later, during the verification process, ECHA identifies that company have claimed an incorrect size, there will will be a duty to pay the balance of the accurate fee and an administrative charge of up to EUR 19 900.

A stepwise approach on how to determine and declare the correct size of enterprise is available on ECHA’s website.

It is also important to regularly check REACH-IT accounts for any messages and tasks from ECHA, registrant should keep our contact details up to date and react to ECHA’s requests.

More information – REACH Registration on Ekotox: https://ekotox.com.ua/reach-registration/

Actual Ekotox webinars: https://reachtraining.eu/en/seminars

EKOTOX CENTERS

• Legislation and Regulatory Compliance Services (EU REACH, CLP, detergents, RoHS, WEEE, POPs…)
• Safety Data Sheets and products/mixtures registration on the EU member states markets (Poison Centers), UFI and more
• Biocides
• Cosmetics Safety
• Chemicals risk assessment / management
• Environmental Health & Safety & Risk Assessment
• Occupational Health & Safety & Risk Assessment

 Ekotoxikologické centrum CZ
Centrum Ekotoksykologiczne (PL)
Ekotoxikologické centrum Bratislava, s.r.o. (SK)

Tomášikova 10/F, 821 03 Bratislava
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Tel.: +421 (2) 4594 3712, 4594 5223
E-mail: ekotox(at)ekotox.eu

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Inspections for the eighth major Forum enforcement project have started. The project will check whether companies selling hazardous substances, mixtures, biocidal products and articles online in Member States and EEA countries comply with REACH, CLP and the Biocidal Products Regulation.

https://echa.europa.eu/-/inspectors-to-check-products-sold-online-that-contain-harmful-substances

 The eighth major Forum enforcement project (REF-8) concentrating on the online sale of substances, mixtures and products has entered its operational phase and will run until 31 December 2020. 29 countries will participate in the project.

This inspections are following previous controling activities and based on the „Final report on the Forum Pilot Project on CLP focusing on control of internet salesReporting period: January – October 2017“:
In total, 1 083 (82.4 %) non-compliances in reference to Article 48(2) of CLP were found.
In 83.3 % of non-compliant cases, no information was provided on hazard statements and/or supplementary statements.
More to be found in: https://echa.europa.eu/documents/10162/13577/forum_project_report_on_control_of_internet_sales_en.pdf

The REF-8 project will target products for the general public and professionals, available in private companies’ webshops and in marketplace platforms, such as Amazon and eBay.

Inspectors will check if buyers are informed about the existence of hazardous substances before the purchase is completed and if particular aspects of the regulations are fulfilled. This can be checked by controlling the advertisement of a chemical product or by purchasing products and subsequently analysing them.

For example, inspectors will look into restricted substances found in products commonly sold online such as toys and textiles and check against the requirements laid down in the REACH Regulation.

For the Biocidal Products Regulation, the project covers both authorised biocidal products and those available under the transitional regime. The transitional regime is the period of time where biocidal products are still governed by national provisions in each Member State.

The project will focus on the online product information and online advertisements but inspectors may visit the companies for on-site inspections, whenever they consider it relevant.

The results of the project are expected to be published at the end of 2021.

More information – Safety data Sheets on Ekotox: https://ekotox.com.ua/safety-data-sheet-sds/

Actual Ekotox webinars: https://reachtraining.eu/en/seminars

EKOTOX CENTERS

• Legislation and Regulatory Compliance Services (EU REACH, CLP, detergents, RoHS, WEEE, POPs…)
• Safety Data Sheets and products/mixtures registration on the EU member states markets (Poison Centers), UFI and more
• Biocides
• Cosmetics Safety
• Chemicals risk assessment / management
• Environmental Health & Safety & Risk Assessment
• Occupational Health & Safety & Risk Assessment

 Ekotoxikologické centrum CZ
Centrum Ekotoksykologiczne (PL)
Ekotoxikologické centrum Bratislava, s.r.o. (SK)

Tomášikova 10/F, 821 03 Bratislava
Slovenská republika
Tel.: +421 (2) 4594 3712, 4594 5223
E-mail: ekotox(at)ekotox.eu

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