New REACH Annex XV Dossiers proposed by Member States

Eight new substances were proposed by various EU member states and the commission to the REACH Annex XV.  These came from Germany, Sweden, & Finland and have a deadline for comments.  Next step is potential add to the Candidate List.

The substances and examples of their uses are:

  • octamethylcyclotetrasiloxane(D4) (EC 209-136-7) – used in washing and cleaning products, cosmetics and personal care products and polishes and waxes;
  • decamethylcyclopentasiloxane (D5) (EC 208-764-9) – used in cosmetics and personal care products, polishes and waxes, washing and cleaning products and textile treatment products and dyes.
  • dodecamethylcyclohexasiloxane(D6) (EC 208-762-8) – used in polishes and waxes, washing and cleaning products, and cosmetics and personal care products;
  • ethylenediamine(EC 203-468-6) – used in adhesives and sealants, coating products, fillers, putties, plasters, modelling clay, and pH regulators and water treatment products;
  • terphenyl hydrogenated(EC 262-967-7) – used as plastic additive, as solvent, in coatings/inks, in adhesives and sealants;
  • lead(EC 231-100-4) – used in metals, welding and soldering products, metal surface treatment products, polymers and heat transfer fluids;
  • disodium octaborate(EC 234-541-0) – used in antifreeze products, heat transfer fluids, lubricants and greases and washing and cleaning products;
  • benzo[ghi]perylene(EC 205-883-8) – not registered under REACH; normally not produced intentionally, but rather occurs as a constituent or impurity in other substances.

The deadline for comments is 23 April 2018.

EU: ECHA Proposes Seven Substances for Authorisation

Seven substances of very high concern (SVHCs) are recommended to be added to the REACH Authorisation List.

They have been prioritized from the Candidate List because of their intrinsic properties in combination with high volume and widespread uses, which may pose a threat to human health or the environment. Some of these substances are currently not used in the EU but could replace other substances recommended for or already on the Authorisation List. They are recommended to avoid regrettable substitution.

The final decision on the inclusion of the substances in the Authorisation List and on 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.

EU Withdrawal Bill questions lead Minister to state intention to convert REACH into UK law

Author: Alex Martin, RINA, knowledge partner with Compliance & Risks

Understandably enough, much of the 2017 media coverage of Brexit focused upon the negotiations in Brussels, between the UK Government and the European Commission on such thorny topics as financial settlement, citizens’ rights and the future of the UK/Irish border. This is set to continue in 2018 as the negotiations move on to a second phase, with trade the focus this time round.

Whatever deal results from these negotiations will not automatically conclude Brexit though. In the UK, the Government has conceded to the deal being voted upon (something that remains contentious since the vote looks set to be a choice between “the deal negotiated” and “no deal”) while, on the EU side, it will go to the European Council and Parliament and, potentially, the national legislative chambers of the EU-27.

Ahead of a final deal being announced and subject to voting in UK Parliament, the UK Government is paving the way for Brexit with the passage of a Bill: the European Union (Withdrawal) Bill 2017-19. It is important to stress that, in the UK, a Bill is not a law; it only becomes so once it has been voted upon and is then granted royal assent to become an Act of Parliament.

At the time of writing, the EU Withdrawal Bill had been through three readings in the House of Commons and various Committee sittings. It is poised to progress to a second reading in the Lords in January 2018. Politically, the key areas of debate include a vote on a final deal but also the Government gaining powers at the expense of Parliament and whether repatriated powers rest with Westminster or are divided across the Devolved Administrations.

For businesses involved in the supply of hardware, engineered goods and electrical equipment, these are clearly not day-to-day concerns pertaining to the likes of market access and product regulatory compliance. This makes some of the more technical discussions that have come about in Committee sittings of interest. For example, the House of Commons’ Environmental Audit Committee has asserted that “up to a third of EU environmental law cannot simply be ‘copy-pasted’ into UK law” and its chair, Mary Creagh MP, has tabled amendments to the Withdrawal Bill, including the REACH-related “NC61” amendment that seeks to ensure the UK continues to adhere with REACH post-Brexit through adoption of new legislation.

What is perhaps of further interest is that the NC61 amendment was not carried when tabled in the Commons in December of last year. Does that then mean that, come 2019, the UK will no longer adhere to REACH? The short answer to that is no, and that continuity is on the cards. Indeed, the UK Brexit Minister, Steve Baker MP, provided confirmation in the House of Commons that the UK Government “will use the powers in [the] Bill to convert current EU chemicals law including REACH into domestic law” adding that any associated standards will “continue to apply in the UK”.

The trouble is, this answer only takes us so far when the UK’s future relationship with the EU is unknown, meaning that its interaction with EU institutions like the European Court of Justice (ECJ) and EU agencies like the European Chemicals Agency cannot be foretold. This makes the point about copy-pasting very pertinent. Simply replicating the text of an EU Regulation into a UK Act or Statutory Instrument is problematic when it refers to one or more specific EU agencies: will the UK defer to these agencies? Will the UK fund them even? There is also the working assumption with any EU Regulation that should the interpretation of the law ever require judicial resolution the ECJ would appoint a judge to do this. What happens then? Does the UK follow the ECJ ruling, leave the legal ambiguity as is, or initiate its own judicial investigation?

When reflecting on these questions, it is in some respects worrisome that the NC61 amendment was not carried. However, it really does seem to boil down to what the new EU-UK relationship will be: in or out of the Single Market, ditto the Customs Union, continuation in funding of agencies or not, and so on. One cannot help but feel that the political classes need to hasten their outlining of a complete picture this year such that, to continue with the painting analogy, the finer detail can be brushed in soon after.

EU: European Commission publishes first-ever plastics strategy, Feb 9, 2018

The EU Commission has developed and published a plastics strategy designed to do more for the circular economy and truly address the 3 Rs: Reuse, Repair, and Recycling.  The new strategy will supposedly include design, which is one of the most challenging aspects in complex and very complex articles.

This article By Dr. Alex Martin of RINA Consulting gives more detail:

The European Commission has developed and published a wide-ranging strategy pertaining to plastics that seeks to curb the environmental pollution that arises from the material’s manufacture, use and, most prominently, disposal. In sum, the strategy seeks to lay the foundations for what the European Commission calls the “new plastics economy” in which the design and production of plastics and plastic products “fully respect reuse, repair and recycling needs”; in other words the strategy is about the role of plastics in transitioning towards a more circular economy. An overarching aim is that, by 2030, all plastic packaging supplied in the EU is to be recyclable.

Context 

The strategy begins by contextualizing the challenges posed by plastics. These are said to span: 

  • A twentyfold increase in the global production of plastics over the last 50 years; 
  • Little change in the low reuse and recycling rates that exist for plastics at end of life; 
  • Corresponding to the above, high rates of landfilling and incineration that have yet to dip and remain a preferred disposal route for plastics waste; 
  • Demand for recycled plastics only accounting to a small percentage of the overall plastics demand in Europe (circa 6%); 
  • The attribution of plastics production and waste plastics incineration to the generation, globally, of approximately 400 million tonnes of carbon dioxide per year. 

 Moreover, the issue of marine pollution is of particular note. As the strategy explains: “very large quantities of plastic waste leak into the environment from sources on both land and at sea, generating significant economic and environmental damage… It is estimated that plastic accounts for over 80% of marine litter.” The strategy also gives a European dimension to this, asserting that, in the EU, 150,000-500,000 tonnes of plastic waste enter the oceans every year. While this might be a relatively small proportion of global marine litter, it is problematic as it can end up in especially vulnerable marine areas like the Mediterranean Sea and parts of the Arctic Ocean. This can have an economic impact; the strategy states that the cost of litter to EU fisheries is about 1% of total revenues from catches by the entire EU fleet.

Focus on three plastics types 

The strategy stresses the need to tackle environmental pollution that arises from three particular types of plastics: “single-use”, plastics with biodegradable properties, and microplastics. Single-use plastics span the likes of small packaging, bags, disposable cups, lids, straws and cutlery. In these instances, plastic is widely used due to its lightness, low cost and practical features. Plastics with biodegradable properties are a potential problem as their classification come be something of a misnomer; generally they degrade under specific conditions that may not always be easy to find in the natural environment and might not be apparent to those using or consuming the materials. Microplastics refers to tiny fragments of plastic below 5mm in size. They can enter the seas directly, or else occur from the fragmentation of large pieces of plastic waste over time.

Key measures 

The strategy presents various measures, with the following a summary account of these: 

  • Promotion of design for recyclability. This is seen to be a way to incentivize producers of plastic articles (that might include items of electrical and electronic equipment) and packaging to consider, far more thoroughly than is common today, recycling or reuse when they design their products. Plastics are made from a range of polymers and are highly customized, with specific additives to meet each manufacturer’s functional and/or aesthetic requirements. The diversity can complicate the recycling process, make it more costly, and affect the quality and value of recycled plastic. Hence, the European Commission believes change in product design to be one of the keys to improving recycling levels. For businesses involved in the manufacture, import and/or distribution of electrical and electronic equipment in the EU, this may well mean that ecodesign legislation comes to focus upon plastics usage and recyclability in the years ahead. What is additionally of note is the referencing, in the strategy, to revision of the EU Packaging and Packaging Waste Directive, something that is being set up as the main legal instrument for effecting the required changes to bring about the “all plastic packaging to be recyclable from 2030 onwards” target. Any revision will likely look again at the essential requirements of the Directive, which address recyclability as well as issues like use of noxious substances. It is interesting that the harmonized standards that were created to help manufacturers achieve these requirements have been barely used and are by no means on a par with the harmonized standards used for demonstrating product safety under, for example the Low Voltage Directive. 
  • Boost demand for recycled plastics. This measure is intent upon developing a European market for recycled plastics as well as developing quality standards for sorted plastic waste and recycled plastics. A pledge is made that, by 2025, 10 million tonnes of recycled plastics are to find their way into new products. 
  • Better and more harmonized separate collection and sorting. This measure is framed to be implemented via (a) new guidance on separate collection and sorting of waste, and (b) better implementation of existing obligations on separate collection of plastics. 
  • Generate investment while also harnessing global action (the latter spans global collection and recycling streams, international standards, and certification schemes for recycled plastics). 
  • Introducing specific legislative initiatives pertaining to single-use plastics, plastics with biodegradable properties, and microplastics. The thinking here spans new Extended Producer Responsibility legislation; a clearer regulatory regime for plastics with biodegradable properties that gives emphasis to labelling and better instruction pertaining to the conditions under which such plastics do/do not degrade; and further examination of the instances when microplastics are intentionally added to product categories, the risks, and, potentially, restrictions with the European Chemicals Agency already tasked to perform a restriction proposal that would also have oxo-degradable plastics in its scope (such plastics are designed to degrade into particles and have uses as agricultural films, rubbish bags and food packaging). 

Outlook 

Publication of the strategy appears to have generated a mixed response from stakeholder groups, with several prominent trade and industry associations supportive but a number of environmental non-governmental organizations pushing for more commitments. For the electronics and engineered goods sectors, the likely impact of the strategy will not be now but in revision of the Packaging and Packaging Waste Directive (long overdue since it has not been significantly overhauled in the 24 years since it was first adopted), furtherance of ecodesign requirements, and, potentially, new restrictions on particular types of plastics – most likely through additional entries to REACH Annex XVII. In the meantime, we have 12 years to wait before we know whether the EU’s first-ever plastics strategy proved a success. If, come 2030, all plastic packaging in use in the EU is actually recyclable then it will have been. At the moment, that feels like something of a tall order to achieve. The vision is, however, laudable and certainly a goal to shoot for.

EU: Substances Potentially Subject to Compliance Checks During 2017 under REACH, Revised List, August 2017

ECHA’s announcement of REACH compliance reviews seems to be about dossiers, rather than end products. The compliance check will mainly focus on eight key endpoints such as reproduction toxicity, carcinogenicity, biodegradation and bioaccumulation. There are still difficulties getting the SIEFs and registrants connected to final manufacturers and end products.

ECHA has started to implement its new compliance check strategy. The goal is to increase efficiency and transparency in dossier evaluation and focus on those substances that matter the most for human health and the environment. Some practices will also change as of January 2015.

Increased transparency of compliance check plans

ECHA starts publishing a list of substances for which a compliance check would in all probability be conducted. This gives the registrants the possibility for early dossier updates before the compliance check starts. However, the list is indicative and non-exhaustive: ECHA reserves the right to open further compliance checks on any dossier at any time and without prior notice to the registrants.

The compliance check will mainly focus on eight key endpoints which are outlined in the new compliance check strategy. These are genotoxicity, repeated-dose toxicity, pre-natal developmental toxicity, reproduction toxicity, carcinogenicity, long-term aquatic toxicity, biodegradation and bioaccumulation endpoints.

Compliance checks: no dossier updates considered during the decision-making

To shorten processing times, ECHA will no longer take into account dossier updates after the draft decision on a compliance check has been sent to the registrant for comments.

The change does not affect the 30-day period given to registrants to submit comments on the draft decision. Comments will be taken into account in the decision making.

ECHA continues to offer informal interaction with registrants to clarify the process and content of the draft decision. The registrants are expected to update their dossier after the final decision, before the given deadline. ECHA will evaluate whether the requirements of the decision are met after this deadline.

Testing proposals: 60 days to update

When the registrants receive a draft decision on a testing proposal, they will have 30 days to comment and a further 30 days to update their dossier, where relevant. To avoid unnecessary testing on vertebrate animals, a more flexible approach may on request be taken in case of testing proposals involving read-across and categories for two or more registered substances. The applicable deadlines will be stated in ECHA’s draft decision and the notification letter.

ECHA tightens its practice on dossier updates  authored by European Chemicals Agency (ECHA) on Jan 28, 2015

 

 

EU: Biocidal Products Regulation (EU) No 528/2012

The European Biocidal Products Regulation, while having been in place and updated in 2017 is showing product reporting impact as automotive companies expect suppliers using the new Chemistry Manager feature within IMDS to attempt to get material supplier regulatory information on potential biocidal substances.

The European Biocidal Products Regulation, while having been in place and updated in 2017 is showing product reporting impact as automotive companies expect suppliers using the new Chemistry Manager feature within IMDS to attempt to get material supplier regulatory information on potential biocidal substances.

This Regulation lays down rules for:
(a) the establishment at Union level of a list of active substances which may be used in biocidal products;
(b) the authorisation of biocidal products;
(c) the mutual recognition of authorisations within the Union;
(d) the making available on the market and the use of biocidal products within one or more Member States or the Union;
(e) the placing on the market of treated articles.