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Chemicals Strategy for Sustainability

Chemicals Strategy for Sustainability

The European Green Deal is the EU’s new growth strategy.

The Commission’s strategy provides an action plan to:

  • Ban the most harmful chemicals in consumer products – allowing those chemicals only where their use is essential.
  • Pay attention to the cocktail effect of chemicals when assessing chemical risks.
  • Phase out per- and polyfluoroalkyl substances (PFAS) in the EU, unless their use is essential.
  • Boost investment and innovative capacity for the production and use of chemicals that are safe and sustainable by design throughout their lifecycle.
  • Promote the EU’s supply and sustainability of critical chemicals.
  • Establish a simpler “one substance, one assessment” process for assessing the risks and hazards of chemicals.
  • Play a leading role globally by championing and promoting high chemical safety standards and not exporting chemicals banned in the EU.

Green Deal

2.1.8. A zero pollution ambition for a toxic-free environment

Creating a toxic-free environment requires more action to prevent pollution from being generated as well as measures to clean and remedy it. To protect Europe’s citizens and ecosystems, the EU needs to better monitor, report, prevent and remedy pollution from air, water, soil, and consumer products. To achieve this, the EU and Member States will need to look more systematically at all policies and regulations. To address these interlinked challenges, the Commission will adopt in 2021 a zero pollution action plan for air, water and soil.

The natural functions of ground and surface water must be restored. This is essential to preserve and restore biodiversity in lakes, rivers, wetlands and estuaries, and to prevent and limit damage from floods. Implementing the ‘Farm to Fork’ strategy will reduce pollution from excess nutrients. In addition, the Commission will propose measures to address pollution from urban runoff and from new or particularly harmful sources of pollution such as micro plastics and chemicals, including pharmaceuticals.

There is also a need to address the combined effects of different pollutants.

The Commission will draw on the lessons learnt from the evaluation of the current air quality legislation
. It will also propose to strengthen provisions on monitoring, modelling and air quality plans to help local authorities achieve cleaner air. The Commission will notably propose to revise air quality standards to align them more closely with the World Health Organization recommendations.

The Commission will review EU measures to address pollution from large industrial installations. It will look at the sectoral scope of the legislation and at how to make it fully consistent with climate, energy and circular economy policies.

The Commission will also work with Member States to improve the prevention of industrial accidents.

To ensure a toxic-free environment, the Commission will present a chemicals strategy for sustainability.

This will both help to protect citizens and the environment better against hazardous chemicals and encourage innovation for the development of safe and sustainable alternatives.

All parties including industry should work together to combine better health and environmental protection and increased global competitiveness.

This can be achieved by simplifying and strengthening the legal framework.

The Commission will review how to use better the EU’s agencies and scientific bodies to move towards a process of ‘one substance – one assessment’ and to provide greater transparency when prioritising action to deal with chemicals. In parallel, the regulatory framework will need to rapidly reflect scientific evidence on the risk posed by

* endocrine disruptors,

* hazardous chemicals in products including imports,

* combination effects of different chemicals and

* very persistent chemicals.

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Majority of inspected products sold online breach EU chemicals laws

Majority of inspected products sold online breach EU chemicals laws

Ekotox Centers support companies to comply !

The European Chemicals Agency’s Enforcement Forum for Exchange of Information on Enforcement has finalised its eighth REACH-EN-FORCE where the compliance of certain mixtures and articles sold online were assessed. This was an EU-wide enforcement project carried out during 2020 in 29 countries of the EEA and Switzerland.

When inspecting the offers of products sold online, inspectors could evaluate their compliance with:

  1. CLP Regulation in regard to:
  • whether the online advertisement of a hazardous mixture provides information to the customer about the type of hazard as indicated on the label;
  • for hazardous substances, whether the customer is informed about the hazard class and/or the applicable hazard category;
  1. REACH obligation:
  • for the most updated version of the safety data sheet (SDS) to be supplied/available with the hazardous substance or mixture for industrial/professional uses;
  • an official language of the receiving Member State or upon request;
  • specific entries of REACH Annex XVII: products or articles containing restricted substances;
  1. BPR duties:
  • which were assessed by checking the online advertisement of the biocidal product (BP);
  • whether it was the sale of an authorised BP or made available under transitional measures.

The total number of inspected products were 5730. The results are as follows:

Reason of
incompatibilities
Percentage of
non-compliance
Non-compliance with REACH regulation 78%
Non-compliance with the BRP regulation 77%
Non-compliance with CLP labeling 75%
No safety data sheet 5%
Non-compliance with substance restriction 95%
Non-compliance with product restrictions 25%
Violations of CMR substances 99%

Table 1: Results of non-compliance of controlled products.

For non-compliant products, measures were taken by enforcement authorities to bring companies into compliance. Where enforcement measures were taken, the most common follow-up actions were “Removing the product offer from the website’’ (2 140 products, 53 %) and “Bringing the information in the advertisement into compliance” (928 products, 23 %).

Recommendations for shops:

  • Get familiar with the EU/national legislation for consumer products when setting up a website for online sales.
  • Contact the national helpdesks, national enforcement authority (NEA) website, ECHA, European Commission, Market Surveillance authorities, etc. for needed information.
  • Use the information provided in the “Your Europe” portal, in line with the Single Digital Gateway Regulation, which provides online access to information concerning the relevant rights, obligations and rules arising from EU and national law.
  • Be more proactive to avoid non-compliances.

Original article: European Chemicals Agency

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POPs in Waste – EU Commission proposing new strict limits

POPs in Waste – EU Commission proposing new strict limits

 The European Commission adopted a proposal to protect human health and the environment from some of the most harmful chemicals in waste – Persistent Organic Pollutants (POPs).

The proposal tightens the limits for these chemicals in waste, preventing them from re-entering the economy.

With today’s proposal, the Commission is proposing to introduce stringent limits for the following three substances, or groups of substances, in waste:

  • perfluorooctanoic acid (PFOA) and its salts and related compounds – found in waterproof textiles and fire-fighting foams;
  • dicofol – a pesticide, previously used in agriculture;
  • pentachlorophenol, its salts and esters – found in treated wood and textiles.

In addition, the Commission is proposing to tighten the maximum limits in waste for another five substances or substance groups that are already regulated.

The proposal is an important step in achieving a more circular economy as announced under the Circular Economy Action Plan. It contributes to the European Green Deal‘s Zero Pollution Action Plan and to the Chemicals Strategy for Sustainability with its associated action on per- and polyfluoroalkyl substances (PFAS), often dubbed “forever chemicals”.

Ekotox Centers provide support and assistance for customers in Chemicals Management including POPs: https://ekotox.com.ua/chemicals-management/

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New EU PCN format

New EU PCN format

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.
Version 4.0, published on 25 October 2021.
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Actual WEBINARS

Actual WEBINARS

New webinars in area of the EU legal requirements for products and chemicals published.

Highlights:

EU Biocides Authorisation “Webinar” – 2.11.2021
EU PCN + UFI Notification “Webinar” – 3.11.2021
SCIP “Webinar” – 8.11.2021
EU Cosmetics Safety Assessment *Webinar* – 11.11.2021

 

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Updated application for REACH authorisation formats

Updated application for REACH authorisation formats

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.

ECHA link: https://echa.europa.eu/-/updated-application-for-authorisation-formats

Ekotox REACH authorisation link: https://ekotox.com.ua/reach-authorisation/

Ekotox Centers provide complex support for the REACH authorisation application.
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4.5.2021 – Revision of EU REACH; Inception Impact Assessment (IIA) on chemicals strategy actions – You Can Comment till 01 June 2021

4.5.2021 – Revision of EU REACH; Inception Impact Assessment (IIA) on chemicals strategy actions – You Can Comment till 01 June 2021

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
3.2.2021 – the use of nonylphenol ethoxylates (NPEs) in textiles that are meant for consumers and placed on EU market is limited.

3.2.2021 – the use of nonylphenol ethoxylates (NPEs) in textiles that are meant for consumers and placed on EU market is limited.

Entry 46a
Nonylphenol ethoxylates (NPE) (C2H4O)nC15H24O
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.
https://echa.europa.eu/documents/10162/7dcd73a4-e80d-47c5-ba0a-a5f4361bf4b1
EU Inspections to Control the REACH Authorisation Duties 2021

EU Inspections to Control the REACH Authorisation Duties 2021

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.

ECHA 22.1.2021
https://echa.europa.eu/-/authorisation-obligations-and-recovered-substances-in-the-scope-of-two-forum-enforcement-projects

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REACH Authorisation

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Candidate List updated with two chemicals that are toxic for reproduction

Candidate List updated with two chemicals that are toxic for reproduction

ECHA News 19.1.2021 https://echa.europa.eu/sk/-/candidate-list-updated-with-two-chemicals-that-are-toxic-for-reproduction

The Candidate List of substances of very high concern now contains 211 chemicals

Substances added to the Candidate List on 19 January 2021:

EC No.                 CAS No.              Substance name

205-594-7           143-24-8              Bis(2-(2-methoxyethoxy)ethyl)ether;

–                            –                            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.

ECHA Candidate List: https://echa.europa.eu/candidate-list-table

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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

  • 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
E-mail: ekotox(at)ekotox.eu

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