All companies placing chemical substances onto the markets of the European Union and European Economic Area need to prepare for the United Kingdom’s withdrawal from the EU. New instructions are now available on ECHA’s website.

ECHA recommends companies to prepare for a ‘no deal’ scenario ahead of the UK’s withdrawal on 30 March 2019.

On 17 December 2018, the UK Government published a draft statutory instrument proposing to amend UK domestic waste regulations that implement certain European Directives related to waste management to ensure the continued operation of the UK waste regime post Brexit.

The draft focuses on ensuring that regulatory alignment with the EU continues with focus on waste batteries and accumulators, end of waste criteria, packaging waste, end-of-life vehicle destruction certification, landfill acceptance criteria, the management of waste from extractive industries, and calculation methods for verifying recycling target compliance.

The draft also aims to ensure that the rules set out under the following Directives continue to apply:

  1.  Directive 91/689/EEC on hazardous waste;
  2.  Directive 94/62/EC on packaging and packaging waste as amended by Council Regulation (EC) No 1882/2003;
  3.  Directive 2004/12/EC and Directive 2005/20/EC;
  4.  Directive 2008/98/EC on waste.

The draft, once enacted, will enter into force on 29 March with the exception of Part 1 and 2 which will enter into force 21 days after the text is finalized.

USA: Significant New Use of Certain Chemical Substances

EPA reopens the comment period for the proposed rule until October 30, 2018. Comments, docket EPA-HQ-OPPT-2017-0414  – must be received on or before October 30, 2018.

On August 17, 2018 EPA proposed significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA) for 27 chemical substances which were the subject of premanufacture notices (PMNs). The chemical substances are subject to Orders issued by EPA pursuant to section 5(e) of TSCA. This action would require persons who intend to manufacture (defined by statute to include import) or process any of these 27 chemical substances for an activity that is designated as a significant new use by these rules to notify EPA at least 90 days before commencing that activity.

The SNUR primarily affects Alkanes, and declares as a “significant new use” of the designated chemical substances as Flame retardants and plasticizers in PVC, polymers, and rubber; flame retardants, plasticizers, and lubricants in adhesives, caulk, sealants, and coatings; additives in lubricants including metalworking fluids; and flame retardants and waterproofers in textiles.”

California (USA): Proposition 65 Implementing Regulations, 27 Cal.Code Regulations 25102 – 27000 – Amendment (on Article 6 Clear and Reasonable Warnings), Regulation, Article 6, 2017


The California Safe Drinking Water and Toxic Enforcement Act has been around since 1986; but the labeling requirements for manufacturers, retailers, and importers updated on Aug 31, 2018.  Proposition 65 requires businesses to provide warnings to Californians about significant exposures to chemicals that cause cancer, birth defects or other reproductive harm.  These chemical can be in the products that are purchased, in homes or workplaces, or released into the environment.


25600.2. Responsibility to Provide Consumer Product Exposure Warnings
The manufacturer, producer, packager, importer, supplier, or distributor of a product may comply with this article either by providing a warning on the product label or labeling affixing a label to the product bearing a warning that satisfies Section 25249.6 of the Act, or by providing a written notice directly to the authorized agent for a retail seller who is subject to Section 25249.6 of the Act…

25603 Consumer Product Exposure Warnings

(a) Unless otherwise specified in Section 25607.1 et seq., a warning meets the requirements of this subarticle if it is provided using one or more of the methods required in Section 25602 and includes all the following elements:

(1) A symbol consisting of a black exclamation point in a yellow equilateral triangle with a bold black outline. Where the sign, label or shelf tag for the product is not printed using the color yellow, the symbol may be printed in black and white. The symbol shall be placed to the left of the text of the warning, in a size no smaller than the height of the word “WARNING”.
(2) The word “WARNING:” in all capital letters and bold print, and:

(A) For exposures to listed carcinogens, the words, “This product can expose you to chemicals including [name of one or more chemicals], which is [are] known to the State of California to cause cancer. For more information go to”
(B) For exposures to listed reproductive toxicants, the words, “This product can expose you to chemicals including [name of one or more chemicals], which is [are] known to the State of California to cause birth defects or other reproductive harm. For more information go to”
(C) For exposures to both listed carcinogens and reproductive toxicants, the words, “This product can expose you to chemicals including [name of one or more chemicals], which is [are] known to the State of California to cause cancer, and [name of one or more chemicals], which is [are] known to the State of California to cause birth defects or other reproductive harm. For more information go to”
(D) For exposures to a chemical that is listed as both a carcinogen and a reproductive toxicant, the words, “This product can expose you to chemicals including [name of one or more chemicals], which is [are] known to the State of California to cause cancer and birth defects or other reproductive harm. For more information go to”
(E) Where a warning is being provided for an exposure to a single chemical the words “chemicals including” may be deleted from the warning content set out in subsections (A), (B) and (D).

(b) A short-form warning may be provided on the product label using all the following elements:
(1) The symbol required in subsection (a)(1).
(2) The word “WARNING:” in all capital letters, in bold print.
(A) For exposures to listed carcinogens, the words, “Cancer –”
(B) For exposures to listed reproductive toxicants, the words, “Reproductive Harm –”

Proposed Prevention and Control of Environmental Pollution by Solid Waste Draft Law

On 11 July 2018, the Chinese Ministry of Ecology and Environment published a draft revision of the Law on Prevention and Control of Environmental Pollution by Solid Waste.

The draft consists of 102 articles in 6 chapters. Compared to the current law, the draft proposes amendments on 50 articles, adding 14 new ones and deleting 4. The main amendments focus on the following:

  • Prevention of second pollution during solid waste recycling and reuse in products
  • Reduction of the volume of waste landfill by reducing solid waste and increasing recycling
  • Strengthening the responsibility of the waste producer; establishing a solid waste discharge license system
  • Extension of manufacturer’s responsibility, encouraging manufacture to improve ecodesign, establish a recycle system and promote reutilization
  • Reform on solid waste import, in particular foreign waste import
  • Establishing domestic waste sorting systems
  • Improving hazardous waste management systems
  • Stricter penalties

Public comments may be submitted online before 18 August 2018

Disclosure of Hazardous Substance Information Found in Products with Vehicles in Scope

Author: California Legislative Counsel, Oct 15, 2017

Existing law regulates the existence of, and disclosure of, specified chemicals and components in consumer products, including phthalates and bisphenol A.

This bill would require a manufacturer of a designated product, as defined, that is sold in the state to disclose on the product label and on the product’s Internet Web site information related to chemicals contained in the designated product, as specified. The bill would authorize a manufacturer to protect certain chemicals from disclosure by use of a generic name, as specified. The bill would prohibit the sale in the state of a designated product that does not satisfy these requirements.

Existing law, the Hazardous Substances Information and Training Act, ensures the transmission of necessary information to employees regarding the properties and potential hazards of hazardous substances in the workplace. A serious and knowing or negligent violation of the act by an employer and every officer, management official, or supervisor having direction, management, control, or custody of any employment, place of employment, or of any other employee is a crime. Existing law requires the Occupational Safety and Health Standards Board to adopt a standard setting forth an employer’s duties toward its employees consistent with specified guidelines, including, among other things, that the employer shall make safety data sheets on substances in the workplace available to employees, collective bargaining representatives, or employee physicians.

This bill would require an employer that is required to make a safety data sheet readily accessible to an employee pursuant to that standard to make readily accessible in the same manner, for designated products in the workplace, certain information included in the online disclosures described above relating to chemicals contained in those products.

New RoHS exemption for Lead in Bearings for RoHS Cat 11

In Annex III, entry 42 is added: 42 Lead in bearings and bushes of diesel or gaseous fuel powered internal combustion engines applied in non-road professional use equipment:

– with engine total displacement ≥ 15 litres;or

– with engine total displacement < 15 litres and the engine is designed to operate in applications where the time between signal to start and full load is required to be less than 10 seconds; or regular maintenance is typically performed in a harsh and dirty outdoor environment, such as mining, construction, and agriculture applications.

Applies to category 11, excluding applications covered by entry 6(c) of this Annex.

Expires on 21 July 2024.

ECHA asks for input about their proposal for Downstream User communication requirements

ECHA is seeking industry input, especially from downstream global users about the proposed process they plan to inform the public about uses of Substances of Very High Concern.

ECHA’s intended approach is to share non-confidential information from the notifications with the public and specific anonymized information with companies that applied for and received Authorization. This transparent approach aims to maximize the usefulness of notifications while respecting confidentiality concerns (for example, as regards confidential business information, information that would raise competition law issues, personal information).  The REACH-IT tool has been modified to allow for company import of data on SVHC uses, include where, what, why and how.  The expectation that alternatives will drive notification from companies that they no longer use an SVHC is a key feature.  However, many areas of the world have restrictions about what business information (ex. Contact names) is allowed to be a required disclosure.

Information that will always be made public (green):

  • Substance
  • Member State where the use takes place
  • Whether the notification’s status is active or inactive (substituted/ceased use)[1].

Information that will be made public unless the Downstream User has claimed this information confidential and has provided a valid justification (grey). ECHA will also consult with the Authorisation Holder about the confidentiality of such information about their Downstream Users:

  • Name of the company which notified the use
  • Location of the site
  • Name of the authorised use concerned by the notification
  • Any quantity information provided.

Information that will not be made public (red):

  • Name of the upstream supplier which holds the authorisation for the notified use
  • Information that can be personal such as the email address and the telephone number provided in the notification
  • Any voluntary information provided about the authorised use, except from the quantity (number of staff involved in the use, brief additional description of the specific use, involvement in substitution activities)
  • Any file attachments uploaded by the Downstream User.

Important Points:

  • Companies can mark their notification as inactive in REACH-IT. This is relevant in case they have stopped use of the SVHC, e.g. because they have now implemented an alternative substance or technology.
  • It should also be noted that Article 118(2) of REACH provides – inter alia – that the disclosure of the precise tonnage of the substance or mixture and disclosure of links between a manufacturer or importer and his distributors or downstream users shall normally be deemed to undermine the protection of commercial interests.

[1] Companies can mark their notification as inactive in REACH-IT. This is relevant in case they have stopped use of the SVHC, e.g. because they have now implemented an alternative substance or technology.

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.