Conditions of restriction
1. Shall not be placed on the market after 3 February 2021 in textile articles which can
reasonably be expected to be washed in water during their normal lifecycle, in concentrations
equal to or greater than 0,01 % by weight of that textile article or of each part of the textile
article.
2. Paragraph 1 shall not apply to the placing on the market of second- hand textile articles or of
new textile articles produced, without the use of NPE, exclusively from recycled textiles.
3. For the purposes of paragraphs 1 and 2, “textile article” means any unfinished, semi-finished
or finished product which is composed of at least 80 % textile fibres by weight, or any other
product that contains a part which is composed of at least 80 % textile fibres by weight,
including products such as clothing, accessories, interior textiles, fibres, yarn, fabrics and
knitted panels.
Inspectors will check whether the SVHCs subject to authorisation that have been placed on the market have been granted an authorisation by the European Commission. They will also check whether uses of these substances comply with the conditions set in the authorisation decisions. The inspections will be carried out in collaboration with national customs and authorities responsible for occupational safety and health legislation (OSH) and for environmental protection.
The enforcement activities for REF-9 will be carried out in 2021 and a report on their results will be available towards the end of 2022.
Inspections have also started in a pilot project on recovered substances. The project is the Forum’s first to examine the interface between REACH and the EU’s Waste Framework Directive. It focuses on the exemption that the recycling sector has from registering substances that they have recovered from waste. The project targets recovered substances that fulfil the end-of-waste status.
The pilot project inspections will be carried out in 2021, while the report with the results of the project is expected during summer 2022.
Webinars and online training: https://ekotoxtraining.com/
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• EU Market compliance; Biocides; Cosmetics Safety; Chemicals risk assessment / management
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– – Dioctyltin dilaurate, stannane, dioctyl-, bis(coco acyloxy) derivs., and any other stannane, dioctyl-, bis(fatty acyloxy) derivs. wherein C12 is the predominant carbon number of the fatty acyloxy moiety.
Companies must follow their legal obligations and ensure the safe use of these chemicals. From January 2021 onwards, they also have to notify ECHA under the Waste Framework Directive if their products contain substances of very high concern. This notification is submitted to ECHA’s SCIP database and the information will later be published on the Agency’s website.
EKOTOX CENTERS Legislation and Regulatory Compliance Services (goods, articles, registration, notification, EU REACH, CLP…); Safety Data Sheets and products/mixtures registration on the EU member states markets (Poison Centers), UFI and more
ECHA/NR/20/43; Helsinki, 16 December 2020
36 % of checked treated articles were found to be non-compliant with labelling requirements under the Biocidal Products Regulation.
The first coordinated enforcement project on biocides (BEF-1) run by the BPR Subgroup of the Forum (BPRS) focused on checking obligations for treated articles in 2019.
National enforcement authorities in 22 Member States inspected almost 1 200 companies and checked more than 1 800 treated articles including clothing, paints, bedding and chemical mixtures. 73 % of the treated articles were produced in the EU.
In 36 % of cases, the quality of information provided on the labels of the treated articles was inadequate. For 42 % of articles and 23 % of mixtures, basic information, such as the name of the biocidal active substance used for treatment of the product was missing.
The draft is for an annual update of the CoRAP and covers the three subsequent years 2021-2023.
It contains substances suspected of posing a risk to human health or the environment. Substance evaluation is the process under REACH Regulation (EC) No 1907/2006 (Articles 44 to 48) that allows for clarification of such potential risks1. The draft CoRAP contains three new substances compared to the current CoRAP 2020-2022.
58 substances are divided for evaluation in 2021, 2022 and 2023, 8 being planned for evaluation in 2021.
From the 60 substances currently included in the CoRAP update published on 18 March 2020, the Member States identified five for withdrawing as, based on new information or changes of circumstances, evaluation is seen as low priority or unnecessary.
For year 2021 following substances will be under evaluation:
EKOTOX CENTERS Legislation and Regulatory Compliance Services (goods, articles, registration, notification, EU REACH, CLP…); Safety Data Sheets and products/mixtures registration on the EU member states markets (Poison Centers), UFI and more
COMMISSION REGULATION (EU) 2020/2081 of 14 December 2020
amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards substances in tattoo inks or permanent make-up https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32020R2081&from=EN
Substances falling within one or more of the following points:
(a) substances classified as any of the following in Part 3 of Annex VI to Regulation (EC) No 1272/2008:
— carcinogen category 1A, 1B or 2, or germ cell mutagen category 1A, 1B or 2, but excluding any such substances classified due to effects only following exposure by inhalation
— reproductive toxicant category 1A, 1B or 2 but excluding any such substances classified due to effects only following exposure by inhalation
— skin sensitiser category 1, 1A or 1B
— skin corrosive category 1, 1A, 1B or 1C or skin irritant category 2
— serious eye damage category 1 or eye irritant category 2
(b) substances listed in Annex II to Regulation (EC) No 1223/2009 of the European Parliament and of the Council
(c) substances listed in Annex IV to Regulation (EC) No 1223/2009 for which a condition is specified in at least one of the columns g, h and i of the table in that Annex
(d) substances listed in Appendix 13 to this Annex.
Shall not be placed on the market in mixtures for use for tattooing purposes, and mixtures containing any such substances shall not be used for tattooing purposes, after 4 January 2022 if the
substance or substances in question is or are present in the following circumstances:
(a) in the case of a substance classified in Part 3 of Annex VI to Regulation (EC) No 1272/2008 as carcinogen category 1A, 1B or 2, or germ cell mutagen category 1A, 1B or 2, the substance is present in the mixture in a concentration equal to or greater than 0,00005 % by weight;
(b) in the case of a substance classified in Part 3 of Annex VI to Regulation (EC) No 1272/2008 as reproductive toxicant category 1A, 1B or 2, the substance is present in the mixture in a concentration equal to or greater than 0,001 % by weight;
(c) in the case of a substance classified in Part 3 of Annex VI to Regulation (EC) No 1272/2008 as skin sensitiser category 1, 1A or 1B, the substance is present in the mixture in a concentration equal to or greater than 0,001 % by weight;
(d) in the case of a substance classified in Part 3 of Annex VI to Regulation (EC) No 1272/2008 as skin corrosive category 1, 1A, 1B or 1C or skin irritant category 2, or as serious eye damage category 1 or eye irritant category 2, the substance is present in the mixture in a concentration equal to or greater than:
(i) 0,1 % by weight, if the substance is used solely as a pH regulator;
(ii) 0,01 % by weight, in all other cases;
(e) in the case of a substance listed in Annex II to Regulation (EC) No 1223/2009 (*), the substance is present in the mixture in a concentration equal to or greater than 0,00005 % by weight;
(f) in the case of a substance for which a condition of one or more of the following kinds is specified in column g (Product type, Body parts) of the table in Annex IV to Regulation (EC) No 1223/2009, the substance is present in the mixture in a concentration equal to or greater than 0,00005 % by weight:
(i) “Rinse-off products”;
(ii) “Not to be used in products applied on mucous membranes”;
(iii) “Not to be used in eye products”;
(g) in the case of a substance for which a condition is specified in column h (Maximum concentration in ready for use preparation) or column i (Other) of the table in Annex IV to Regulation (EC) No 1223/2009, the substance is present in the mixture in a concentration, or in some other way, that does not accord with the condition specified in that column;
(h) in the case of a substance listed in Appendix 13 to this Annex, the substance is present in the mixture in a concentration equal to or greater than the concentration limit specified for that
substance in that Appendix.
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
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.
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:
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.
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.
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