March 2017 Edition

ChemRegs Newsletter

ChemRegs Newsletter – March 2017

REACH after Brexit – update

In our January and February Newsletters we reported on the UK Parliamentary Environmental Audit Committee’s inquiry into the future of chemicals regulation after we leave the European Union. This is particularly salient now that Article 50 of the Lisbon Treaty has been invoked and the government has set out how it plans to remove EU law from the statute book in its Great Repeal Bill, published as a White Paper on 30 March 2017.

The Great Repeal Bill will repeal the European Communities Act, which makes EU law supreme to UK law, and ensure the UK leaves the jurisdiction of the European Court of Justice.
The Bill will also transpose EU legislation into domestic UK law. However, not all EU law can be transposed into UK legislation, including REACH. This is because, using REACH as an example, such legislation may refer to the involvement of an EU institution such as the European Chemicals Agency (ECHA), or be predicated on UK membership of, or access to, an EU regime or system. Once we have left the EU, this legislation will no longer work.

The third, and final, Oral Evidence Session of the Environmental Audit Committee was held on 07 March 2017 with experts from the European Chemicals Agency (ECHA), the Health and Safety Executive (HSE), and the Environment Agency (EA).

The main thrust of this session (as confirmed in the Repeal Bill White Paper) was that no decision on a regulatory regime has yet been made. However, a few points and observations were given:

  •  The debate around chemicals regulation is global, it is not just European.
  • A new (slightly unfortunate) abbreviation popped up during the session – “BREACH”, which is being used as the term for British REACH, or the regime that will replace REACH post Brexit.
  • It was reported that the enforcement of REACH within UK companies by the HSE had been low because funding cutbacks.
  • The EA said REACH was very good at preventing pollution at source, which was cost effective in relation to actual end of pipe pollution incidents. It was better to ban a very polluting chemical at development, than clean up the effects after its release.
  • The HSE believed REACH was very good for the supply chain as it gives a level playing field in terms of obligations. The EA concurred and said placing the burden on manufacturers gave a clear understanding of manufacturer’s obligations.
  • ECHA is a function of the single market and as the Prime Minister has ruled out joining the single market, a new regulatory regime would be sought. The UK will have the capacity to mirror the ECHA regime.
  • The HSE may need more direct money from government, or increased fees from business, in order to fund the new functions and responsibilities that may be needed if the UK has a different regulatory regime post Brexit.
  • Chinese companies have to comply with REACH to access the single market, so UK companies will do the same, but will have a choice for a separate UK market as well. The example of Poland was used, who want the EU to ban methanol in windscreen wash as they have issues with alcohol addiction. The UK windscreen wash could contain methanol for UK and world markets, but substitute the methanol for EU markets.
  • The Committee again recommended the three underpinning principles of European law being written into UK law: the precautionary principle, the polluter pays, dealing with pollution at source.
  • The precautionary principle applies across the board, but within the precautionary principle there is a hazard-based approach or a risk-based approach. Increasingly, some governments in the European Union want more of a hazard-based, which tends to be more onerous.
  • The UK will support a risk-based approach within the precautionary principle, and that will inform whatever approach to chemicals regulation is taken post Brexit.
    The Great Repeal Bill: White Paper can be downloaded from here:
    https://www.gov.uk/government/publications/the-great-repeal-bill-white-paper

Other News

EU Member States to evaluate 115 substances by 2020

ECHA has adopted the updated Community rolling action plan (CoRAP), which starts the evaluation of 115 substances (under the REACH substance evaluation process) over three years from 2017-2019.

The plan contains substances for which there is a suspicion that their manufacture and/or use could pose risks to human health or the environment. It includes substances such as titanium dioxide and graphite, which have a high consumer use.

The substances are selected for evaluation to clarify the concerns related to their exposure and suspected serious hazard properties (persistent, bioaccumulative and toxic (PBT), carcinogenic, mutagenic and reprotoxic (CMR) or endocrine disruptors in combination with wide dispersive consumer use). In addition, other concerns on the substances may be identified during evaluation.
The CoRAP 2017-2019 list can be downloaded from the ECHA website.

POISON CENTRES

COMMISSION REGULATION (EU) 2017/542 of 22nd March 2017 amending Regulation (EC) No 1272/2008 (CLP) enters into force on the 12th April 2017 and applies from 1st January 2020.
However, Article 50 of the Lisbon Treaty gives both sides two years to reach agreement so, unless the UK and the 27 remaining EU member states agree to extend the deadline for talks, the UK will leave on 29 March 2019. This means that the following procedure may not be the one the UK uses!

The new regulation amends the CLP regulation by adding Annex VIII on harmonised information relating to emergency health response and preventative measures.
Article 45 of CLP places a requirement on the EU Member States to appoint a body (or bodies) responsible for receiving information on mixtures considered hazardous on the basis of their health or physical effects. These appointed bodies, known as Poison Centres, are required to have at their disposal all the information required, such as composition/concentration of ingredients in product mixtures, in order to formulate appropriate emergency measures.

The submission of information to Poison Centres is also required under the Biocidal Products Regulation and the Cosmetic Products Regulation. There is also a requirement under REACH to include emergency telephone numbers on Safety Data Sheets (in subsection 1.4) where medical advice can be obtained.

The two main elements introduced by the new regulation are:

  •  A harmonised format for submitting information to appointed bodies. A common EU format will gradually replace the current national information requirements. Information to be provided relates to the chemical composition of hazardous mixtures, identity and concentration ranges of ingredients, and the product category according to a harmonised European Product Categorisation System (PCS).
  • A unique formula identifier (UFI). The UFI is a unique code to be printed on the label of the product. It will create an unambiguous link between a mixture placed on the market and the information on that specific mixture submitted to poison centres, so that the chemical formulation of the product can be precisely and rapidly identified. A precise identification is necessary to provide appropriate curative measures in the case of an emergency call.
  • Importers and downstream users placing hazardous mixtures on the market will be responsible for submitting the required information in the Member States where the mixture is placed on the market. A distinction will be made between mixtures for consumer use, professional use and industrial use.

The new regulation is due to apply from 1 January 2020. To ease the burden on industry it is being introduced as a stepwise approach, depending on the intended use of the mixture. Importers and downstream users must comply from:

  • 1 January 2020 for mixtures for consumer use.
  • 1 January 2021 for mixtures for professional use (not at industrial sites).
  • 1 January 2024 for mixtures for industrial use (at industrial sites).

ECHA has a dedicated Poison Centre website to host the tools to support companies to submit information in a harmonised format to the appointed bodies and poison centres.
This is at https://poisoncentres.echa.europa.eu/home

•PLASTIC BOTTLE AND COFFEE CUP WASTE INQUIRY LAUNCHED

The Environmental Audit Committee have launched an inquiry into the damage being done to the environment by disposable drinks packaging, focusing on the impact of plastic bottles and coffee cups. The inquiry will look at what actions are being undertaken by industry and Government to reduce waste generated by coffee cups and plastic bottles, and investigate possible solutions, including possible taxes, deposits or levies on the use of these products.

It is reported that only 32% of the 2.2 million tonnes of plastic used in the UK in 2014 was recycled. Plastic can also enter our oceans, mainly in the form of bags, food and drink containers, and fishing equipment. Concerns have been raised that plastic in the oceans could outweigh fish by 2050.

Plastic bottles and coffee cups are particularly problematic and only around half of the 35 million plastic bottles sold in Britain every day are currently collected for recycling. Approximately 7 million cardboard coffee cups are thrown away every day, but only 1 in 400 are recycled, leaving over 6.98m going to landfill or ending up in the environment.

USA HAZARDOUS MATERIALS

The US Pipeline and Hazardous Materials Safety Administration (PHMSA), part of the Department of Transportation (DOT), has finally published the delayed Final Rule (HM-215N) to amend its Hazardous Materials Regulations (HMR). This harmonises the US domestic dangerous goods regulations, 49 CFR, with the new international regulations set out in the 19th revised edition of the UN Model Regulations, the 2016 IMDG Code and 2017-2018 edition of the ICAO Technical Instructions.

The USA publishes this rule every two years to maintain consistency with international regulations and standards by incorporating various amendments, including changes to proper shipping names, hazard classes, packing groups, special provisions, packaging authorizations, air transport quantity limitations, and vessel stowage requirements. These include the new UN numbers for engines and the new entries for machinery (UN 3528, UN 3529 and UN 3530), the new lithium battery mark and the new lithium battery Class 9 hazard label.

If the Final Rule had not been implemented, all of the new provisions in the ICAO Technical Instructions, IATA DGR and IMDG would not have been brought into 49 CFR. This means that effectively the new UN numbers, lithium battery mark and Lithium battery Class 9 label would not exist in the US regulations, and therefore could not be used.
The final rule had been listed for publication in January but was delayed by President Trump’s review of new regulations.

For more information on anything in this Newsletter, please contact us at info@chemregs.co.uk

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