Tag: EU

March 17, 2020

Important Brexit deadlines for importers and users of chemicals

The United Kingdom (UK) has formally left the European Union (EU) on the 31 of January 2020. However, the realisation of Brexit is still to be defined by key decisions of the EU and UK, leaving minimal time for any involved party to prepare. Unless otherwise decided, British chemicals no longer remain in the common EU market. This would mean that UK companies’ EU REACH registrations would be void at the end of the transition period, and companies purchasing chemicals from the UK suppliers would be EU REACH importers, needing registrations according to the rules of EU REACH.

Chemical Watch summarises the key dates of Brexit as follows:

31.1.2020: UK leaves EU – the transition period begins
Early 2020: European Commission to publish its draft negotiating objectives for approval
30.6.2020: Deadline for extending the transition period
31.12.2020: End of the transition period (unless decided to be extended)
2022: England’s chemicals strategy to be published

What does this mean for companies?

EU-REACH registrations: current registrations will terminate at the end of the transition period. UK companies having registrations need to transfer their registrations to an EU-27/EEA based company or an Only Representative by the end of the transition period. An authorisation granted to UK based companies will also cease at the end of the transition period. Transfer of authorisations to an EU-27/EEA based Only Representative is recommended by ECHA for securing the supply chain.

UK-REACH registrants will need to provide basic information within 120 days of the country leaving the EU. A transition of 2 years is planned for providing technical information for tonnage bands under UK-REACH. There are still important details to be solved.

There are Statutory Instruments (SI’s) under preparation for creating national UK laws for REACH and CLP Regulations, Prior Informed Consent (PIC) Regulation, Biocides Regulation, Cosmetics, Detergents, Restrictions of hazardous substances in electrical and electronic equipment (RoHS).

The UK Environment Bill was published in October 2019, giving the environment minister powers to amend the UK REACH and its enforcement regulations. The Chemicals Strategy is under preparation. Its expected due date is 2022, well after the transition period (unless decided to be extended).

In January 2021, the UK will start a completely new relationship with EU – either with an agreed and ratified trade deal, or without it.

Are you an importer or user of chemicals within the EU? Are you concerned about how Brexit will affect your business? Our chemical experts are here to help you! Contact us

Helena Niemelä

Senior Consultant, Ecobio Oy

helena.niemela@ecobio.f

Reference: Global Outlook 2020: How will the Brexit endgame shape up? Chemical Watch 28.1.2020.

October 28, 2019

The European Commission has approved the carcinogenicity classification of titanium dioxide dust

The European Commission approved the 14th technical adaptation of the CLP Regulation. It includes the classification of titanium dioxide as a Category 2 inhalation carcinogen. The substance is carcinogenic when inhaled in powders with a concentration greater than 1% and a particle size of titanium dioxide ≤ 10 μm.

The substance will then require a warning label with H351 warning phrase and a health warning pictogram. For mixtures a phrase EUH211 or EUH212 will be required. If approved by the European Parliament and the Council of Ministers, the Regulation is expected to be published in early 2020 and will enter into force 18 months after its publication. The change will have a major impact on the industry, as titanium dioxide is used extensively in for example paints, colours, plastics, paper and coatings, including those used in consumer products.

The European Parliament and the Council will have two months to raise any objection to the publication of the Regulation. If the Regulation proceeds without objection, the amendments to Annex VI to CLP will enter into force within 18 months of the publication of the Regulation.

Do you need help in monitoring your company´s chemical obligations or in implementing classification changes? Our chemical experts will help you!

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October 2, 2019

18 new substances of very high concern recommended to be added to the REACH Authorisation List

ECHA (European Chemicals Agency) has recommended 18 new substances of very high concern (SVHCs) to be added to the REACH Authorisation list, from the Candidate list. The majority of the substances (13) are toxic to reproduction. The other substances includes two respiratory sensitisers, a carcinogen, an endocrine disruptor and a very persistent and very bioaccumulative (vPvB) substance.

One of the recommended substances to be added on the list is Bisphenol A or BPA (4,4′-isopropylidenediphenol) which is a commonly used chemical in the synthesis of plastics. BPA-based plastics are clear and though and used in many consumer products such as water bottles, sports equipment and CD’s.

The substances have been prioritized from the Candidate List because of their intrinsic properties, high volume and widespread uses, which may pose threats to human health or the environment.

The final decision regarding the inclusion of the substances in the list and the dates by which companies will need to apply for authorisation to ECHA will be taken by the European Commission in collaboration with the Member States and the European Parliament.

(ECHA 1.10.2019)

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July 2, 2019

9th Conference on Biodiversity in Trondheim

The Secretariat of the UN Convention on Biological Diversity (CBD), the UN Environment Program (UNEP) and the Norwegian Government arranges the 9th Conference on Biodiversity in Trondheim, today (Tuesday, July 2). About 450 delegates from 120 countries are expected to attend the conference. Representatives consists mainly of decision-makers and experts. Krista Mikkonen, Minister of the Environment and Climate Change in Finland, is participating in the conference.

Why is the conference held?

“In 2020 (in Kunming, China) the Convention on Biological Diversity will adopt a post-2020 global biodiversity framework as a stepping stone towards the 2050 Vision of “Living in harmony with nature”. This vision was agreed under the CBD in 2010 (in Nagoya, Japan), and reads that the vision is a world of “Living in harmony with nature” where “By 2050, biodiversity is valued, conserved, restored and wisely used, maintaining ecosystem services, sustaining a healthy planet and delivering benefits essential for all people.”

The Conference will address the challenges of achieving the 2050 Vision for Biodiversity and explore pathways for the transformational changes needed. The Trondheim Conferences on Biodiversity have since 1993 created opportunities for increasing understanding amongst stakeholders about issues on the biodiversity agenda.

The 9th Trondheim Conference will bring together decision-makers and experts from around the world to learn about and discuss knowledge and know-how for the global post-2020 biodiversity framework. The Conference will directly support the process established by the Convention on Biological Diversity for preparing this framework, with opportunities for major players to discuss key issues informally outside of the negotiation process.” https://trondheimconference.org/

Follow the live-stream from the conference here

Finland´s EU Presidency and its biodiversity agenda

On Monday (1.7.) Finland begun its six-month stint in the rotating presidency of the European Council.

The top priorities of the Finnish Presidency include strengthening the EU’s position as a global climate leader. According to the Finnish EU Presidency program, sustainability must be a common denominator for all EU action, and the implementation of Agenda 2030 for sustainable development must be ensured both within the Union and beyond. EU should raise its profile as a global climate leader by creating a long-term climate strategy which will help EU become carbon neutral in 2050. Finland will drive the EU Presidency with an ambitious and clear road map to improve biodiversity.

During its presidency, Finland will take steps to implement the UN Convention on Biological Diversity and to promote the sustainable use of natural resources and animal welfare.

Ecobio helps you reach the sustainability goals of your company – we help you balance business and nature.

For further information please get in touch:

Email: info@ecobio.fi

Phone: +358 (0)20 756 9450

The ministry of the Environment wrote about this

August 31, 2018

ECHA’s Biocides Stakeholder Day coming up

The European Chemicals Agency ECHA will be hosting the Biocides Day 2018 on the 24th and 25th of October in Helsinki, Finland. The stakeholder day will give insight into the latest developments in biocides at the EU level.

In the EU, the Biocidal Products Regulation (BPR) regulates the placing on the market and use of biocidal products. As a principle, biocidal active substances must be approved for use at Union level, and all biocidal products require an authorisation before they can be placed on the market. Product authorisations take place either at Member State level or as a Union authorization.

As active substances are increasingly being approved for use, the need for the authorization of the biocidal active products containing such active substances are becoming imminent. For example, the deadline for the product authorization application of sodium hypochlorite is already 1.1.2019.

The Biocides Day by ECHA will deal with e.g.
• tips for a successful Union authorisation
• best practices for a product family authorisation
• the impact of Brexit and
• the impact of endocrine disruptor criteria

You can join the day through ECHA’s webpages: https://echa.europa.eu/fi/-/biocides-day

Ecobio’s expert will also be present; you are more than welcome to ask us anything relating to chemical or biocides legislation! Contact us at info@ecobio.fi.

June 20, 2018

Blog: REACH – ripple effects on the whole supply chain

An important milestone for the European chemical industry has been reached as the final REACH registration deadline for substances passed in 31.5.2018. The European REACH Regulation ((EC) No 1907/2006), however, continues to set high standards for the whole industry, from manufacturers, importers, formulators and distributors all the way down to downstream and end users.

Effects on the supply chain

Whilst the REACH registration deadline passed in 31.5.2018 already, it can take up to 3 months for the European Chemicals Agency ECHA to make a registration decision; your supplier might be fully REACH compliant if they have submitted their dossier on time, but might not yet have received a registration decision, i.e. a registration number, from ECHA. In complex cases where an extension might have been received from ECHA and the Director’s Contact Group, receiving a registration decision will take even longer than that.

This also means that the potential effects of the last registration deadline that mainly dealt with SMEs and their substances might affect supply chains with a delay. Whether or not the registering company had enough assets and know-how to pull through the registration might become evident only later on. If a company has decided to cease their manufacture by 31.5.2018, they are still allowed to sell all their supply gathered before the deadline to downstream users as distributors. Whether or not some companies or some products might be dropping out, or the market become more homogenized, will most likely be found out only after the dust of the final registration deadline has settled.

Communicating REACH compliance to authorities and stakeholders

In terms of supply chains and their continuance, it is important to notice that pre-registration numbers are no longer valid. It is also important to notice that either a generic or a company-specific version of the actual REACH Registration number can be put forward. The company-specific version always consists of four parts of numbers, e.g. 01-2119458769-17-0003, whereas the generic form might only consist of three (e.g. 01-2119458769-17 or 01-2119458769-17-XXXX). Make sure that your suppliers have actually registered the substance in their name, and are not just giving you a generic number to keep you content for a while.

A good way to communicate a company’s adherence to REACH and its many requirements is a REACH declaration of compliance. Such a statement can serve as a testimony to the authorities or as communication to customers and other stakeholders to show that your company is indeed REACH compliant in all the relevant aspects of the REACH Regulation. Such a statement is a hard asset outside of Europe as well.

A shift in focus towards formulators

As the burden of REACH has previously been mainly on substance manufacturers and EU importers, the focus of the regulation is now shifting towards formulators. The safe use of mixtures is a topic that will need to be addressed by operators in the coming years in the form of unique formula identifiers (UFI) and poison centre notifications (PCN). This will require a thorough knowledge of the composition and hazardous properties of the supplied mixtures as well. Exposure scenarios and their utilization in communicating the safe use of mixtures will surely be giving formulators some gray hair.

Increasing amount of regulation

As ECHA is now the holder of the world’s largest open database of substance information, plans on how to best utilize the gathered information on the registered substances are big. On a general level this might mean more substance restrictions and harmonized classifications. Manufacturers of highly hazardous substances or those who have submitted incomplete information, on the other hand, might become a target for even more scrutiny.

Reaching the legislative deadline will also most definitely result in increased supervision from national authorities on whether or not companies have fulfilled their various requirements under the REACH Regulation, with regard to substance restrictions and registrations especially. A more scrutinized assessment of SDS’s and of the responsibilities that downstream users have regarding exposure scenarios and their assessment against their own conditions could also result.

Harmonized classifications under the CLP Regulation ((EC) No 1272/2008) themselves can also be a source of restriction, as is now happening with titanium dioxide. A common chemical used as a pigment and thickener in a wide variety of applications for consumer use, including foodstuff, is about to receive a category 2 carcinogen classification, meaning heavy restrictions on its use in many of its current applications.

Competitive edge for European companies

One of the main original aims and visions of the comprehensive chemical legislation that is REACH is to ensure a high level of health and environmental protection. Another aim of the regulation has been to stimulate innovation and enhance the competitiveness of European brands on international markets. As chemical legislation is getting stricter all around the globe, REACH is indeed serving as an important example for other countries striving for increased chemical safety. This is one of the reasons why being REACH compliant is an asset all over the world; still today, REACH is the most advanced chemical legislation in the world.

Consumer image – a threat or a possibility?

An increasing amount of portals and sources for consumers on how to use chemicals safely and on how to find relevant safety information on chemicals have also emerged. Whilst a huge amount of scientifically-based information on chemicals and their safe use is now publicly available, what should never be underestimated is the opinion and views of the general public. Companies should therefore have an understanding of what the data gathered by them actually means and how it can be translated into facts and to transparent stakeholder communication.

Registration in the future

Now that all the three major deadlines for the REACH registration of chemicals in different tonnage bands have passed, the registration of future substances will require more planning in advance; as of now substances will need to be registered before manufactured or imported into the EU in amounts above 1 tonne per year. Make sure to make use of all the relevant exemptions to registration requirements. For R&D substances, for example, a PPORD notification will give your company a 5-year period of reflection before deciding on whether to continue with the substance or not. For substances produced in circular economy processes, further exemptions also apply.

For more of the concrete results that REACH keeps delivering, see the press release of the European Commission on the matter: http://europa.eu/rapid/press-release_IP-18-1362_en.htm

Leea Ojala, Senior consultant

20.6.2018, Helsinki

In case you have any questions about your obligations under the REACH Regulation or are interested in a REACH Declaration of Compliance or a screening of substance restrictions on your chemicals, contact Ecobio’s experts at: info@ecobio.fi or tel. +358 20 756 9450.