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

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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

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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.

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COMMISSION DELEGATED REGULATION (EU) 2020/11 of 29 October 2019 amending Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures as regards information relating to emergency health response

https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32020R0011&qid=1579270288291&from=EN

 Importers and downstream users placing on the market mixtures for consumer use, within the meaning of Section 2.4 of Part A of this Annex, shall comply with this Annex from

1 January 2021.

Importers and downstream users placing on the market mixtures for professional use, within the meaning of Section 2.4 of Part A of this Annex, shall comply with this Annex from

1 January 2021.

 Importers and downstream users placing on the market mixtures for industrial use within the meaning of Section 2.4 of Part A of this Annex, shall comply with this Annex from

1 January 2024.

Importers and downstream users having submitted information relating to hazardous mixtures to a body appointed in accordance with Article 45(1) before the dates of applicability mentioned in Sections 1.1, 1.2 and 1.3 and which are not in accordance with this Annex, shall for those mixtures not be required to comply with this Annex until 1 January 2025.

By way of derogation from Section 1.4, if one of the changes described in Section 4.1 of Part B of this Annex occurs before 1 January 2025, importers and downstream users shall comply with this Annex before placing that mixture, as changed, on the market.

 UFI Codes

A new label element will appear on product labels from 2021 – a 16-character code called the unique formula identifier (UFI).

By 2025, the UFI will be mandatory on the label of all products classified for health or physical hazards. Importers and downstream users placing such products on the market, will have to provide specific product information, including the UFI, to poison centres.

Tools and support to generate the UFI are available on ECHA’s Poison Centres website.

The acronym ‘UFI’ (the same in all EU languages and alphabets, and not to be translated) must be in capital letters and be followed by a 16-character alphanumeric code. The code is divided into four blocks, each separated by a hyphen. While no specific requirements have been set, for instance, for font type or size, the UFI has to be clearly visible and legible on the label of the product.

Given the variation in label sizes, and other labelling requirements competing for label space, the UFI should be positioned so that it is easy to locate (e.g. near the barcode or hazard pictograms). In essence, you must determine how the UFI is displayed on the product in the most effective manner to assist with its communication to poison centres.

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

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

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The Candidate List of substances of very high concern (SVHCs) for authorisation now contains 205 substances.

ECHA link: https://echa.europa.eu/-/four-new-substances-added-to-candidate-list

Helsinki, 16 January 2020 – ECHA has added three new substances to the Candidate List due to their toxicity to reproduction and a fourth due to a combination of other properties of concern. This latter causes probable serious effects to human health and the environment, giving rise to an equivalent level of concern to carcinogenic, mutagenic and reprotoxic (CMR), persistent, bioaccumulative and toxic (PBT) and very persistent and very bioaccumulative (vPvB) substances. The decision to include perfluorobutane sulfonic acid (PFBS) and its salts, was taken with the involvement of the Member State Committee (MSC).

Background

The Candidate List is a list of substances that may have serious effects on human health or the environment. Substances on the Candidate List are also known as substances of very high concern and are candidates for eventual inclusion in the Authorisation List. Once they are on the Authorisation List, industry will need to apply for permission to continue using the substance after the sunset date.

Companies may have legal obligations resulting from the inclusion of the substance in the Candidate List. These obligations may apply to the listed substance on its own, in mixtures or in articles. In particular, any supplier of articles containing a Candidate List substance above a concentration of 0.1 % (weight by weight) has communication obligations towards customers down the supply chain and to consumers. In addition, importers and producers of articles containing the substance have six months from the date of its inclusion in the Candidate List (16 January 2020) to notify ECHA. Information on these obligations and related tools are available on ECHA’s website.

More on obligations in terms of SVHCs on Ekotox: https://ekotox.com.ua/substances-of-very-high-concern-svhc/

Substances included in the Candidate List for authorisation on 16 January 2020 and their SVHC properties:

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

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

______________________________________________________________________

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

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SCIP is the database for information on Substances of Concern In articles as such or in complex objects (Products) established under the Waste Framework Directive (WFD).

Companies supplying articles containing substances of very high concern (SVHCs) on the Candidate List in a concentration above 0.1% weight by weight (w/w) on the EU market have to submit information on these articles to ECHA, as from 5 January 2021.

The SCIP database ensures that the information on articles containing Candidate List substances is available throughout the whole lifecycle of products and materials, including at the waste stage. The information in the database is then made available to waste operators and consumers.

The following suppliers of articles need to provide information to ECHA:

• EU producers and assemblers,
• EU importers,
• EU distributors of articles and other actors in the supply chain placing articles on the market.

Retailers and other supply chain actors supplying articles directly and exclusively to consumers are not covered by the obligation to provide information to the SCIP database.

Suppliers of articles need to submit the following information to ECHA:

• information that allows the identification of the article
• the name, concentration range and location of the Candidate List substance(s) present in that article
• other information to allow the safe use of the article, notably information to ensure proper management of the article once it becomes waste.

The information submitted to the SCIP database will be publicly available and therefore readily available to waste operators to bridge the current gap in the information flow.

ECHA will publish the information, as received, on its website. The quality of the data remains the responsibility of each duty holder. At the same time, ECHA will ensure the protection of confidential business information where justified. For example, the data that allows to establish links between actors in the same supply chain will not be made publicly available.

How REACH defines an article

According to REACH Article 3(3), an article is an object which during production is given a special shape, surface or design which determines its function to a greater degree than its chemical composition.

A “complex object” is an object made up of more than one article.

Articles that are assembled or joined together in complex objects remain articles, as long as they keep a special shape, surface or design, or as long as they do not become waste.

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