The Poison Centre Notification (PCN) format aims to structure the information on hazardous mixtures classified for health or physical hazards available to poison centres in cases of poisoning incidents in the EU.
The format is XML-based and defined by the harmonised requirements laid out in Annex VIII to the CLP Regulation and is incorporated into the PCN dossier preparation tools offered by ECHA. It is also available for companies to prepare their own tools based on the PCN format, for example when using the system to system service. Regardless of which tools are used to prepare, the format must be adhered to.
The PCN format is compatible with IUCLID, a tool developed by ECHA in collaboration with the OECD, which promotes the harmonisation of chemicals data. You can find additional information about this tool on the IUCLID website.
New EU PCN format
Annual updates of the format occur in October in line with the IUCLID release schedule. The format is made available as a set of XML schema definition files (XSDs). There is also a data model that shows all relevant fields and their interconnections.
ECHA has published an updated format for companies to use when applying for authorisation to use substances of very high concern (SVHCs).
The new format combines the analysis of alternatives, the socio-economic analysis and, when relevant, a substitution plan into a single document.
The new format is easier for applicants to fill in. The possibility to submit separate documents has been removed making the application process more efficient and the documents more coherent. The instructions on confidentiality have also been updated.
At the same time, the opinion format for the Committees for Risk Assessment (RAC) and for Socio-Economic Analysis (SEAC) has been revised to take the General Court’s judgments in two authorisation cases into account.
The judgments concerned situations where suitable alternatives are available in general and the applicants would need to submit a substitution plan. As requested by the European Commission, the opinion format also includes “a conclusion on whether or not the applicant has shown that the benefits for society from using the substance outweigh the risk to human health or the environment”.
Applicants should start using these formats immediately.
However, applications may be submitted in the old format until the end of 2021 if applicants have already finalised or are close to finalising the content of their application.
INCEPTION IMPACT ASSESSMENT – Revision of EU legislation on registration, evaluation, authorisation and restriction of chemicals – was published 04 May 2021.
The European Green Deal sets out the ambition to reach zero pollution for a toxic-free environment. As part of this ambition, the chemicals strategy for sustainability announces actions to better protect people and the environment against hazardous chemicals and to encourage innovation to develop safe and sustainable alternatives. Achieving these goals requires revising the rules governing the registration, evaluation, authorisation and restriction of chemicals in the EU.
The Chemicals Strategy for Sustainability recognises the need for a targeted revision of REACH to achieve its objectives by addressing the following problems that have been identified:
REACH is the most advanced knowledge base globally but there are still gaps in knowledge of many substances. The information required on critical hazard classes does not allow a sufficiently thorough hazard assessment, including for carcinogenicity, neurotoxicity, immunotoxicity and endocrine disruption. The same applies to intermediates, polymers, and substances in the lowest tonnage range, and no assessment of risks is required for non-threshold substances.
Other aspects:
The registrants’ safety assessments
The communication in the supply chains
The evaluation of registration dossiers and substances
The authorisation procedure
The current restriction process
The control and enforcement
Feedback period: 04 May 2021 – 01 June 2021 (midnight Brussels time)
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
Ekotoxikologické centrum CZ
Centrum Ekotoksykologiczne (PL)
Ekotoxikologické centrum Bratislava, s.r.o. (SK)
Tomášikova 10/F, 821 03 Bratislava; Slovak Republic; Tel.: +421 (2) 4594 3712, 4594 5223
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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.
