REACH For The Stars! – Chemicals

Cooley’s Productwise Bitesize brings you a short
introduction to the REACH Regulation.

What is it called?

Regulation (EC) 1907/2006 on the Registration, Evaluation,
Authorisation, and Restriction of Chemicals (more commonly known as
“REACH“).

What is it about?

REACH is the key EU Regulation regulating chemicals in the EU.
It applies to the manufacture, placing on the market and use of
chemical substances in the EU. REACH applies to chemical substances
on their own (for example, lead), in mixtures (for example, paint)
and in finished products (for example, a smartphone).

After Brexit, EU REACH is no longer directly applicable in the
UK, where the EU regulation has been replaced by UK REACH, which
largely follows the same approach embedded in EU REACH. Businesses
that manufacture, place on the marker or use chemical substances in
the EU and the UK must now comply with both regulatory regimes. In
Northern Ireland, however, EU REACH will continue to operate under
the Northern Ireland Protocol.

The key requirements of REACH and UK REACH are as follows:

• Registration: the overarching principle of
  REACH is “no data, no market“, meaning that no
  substance can be manufactured or placed on the market unless it is
  registered with the European Chemicals Agency
  (“ECHA“) for the EU or the Health and
  Safety Executive (“HSE“) for Great
  Britain. Registration is based on the principle “one
  substance, one registration“, meaning that manufacturers
  and importers of the same substance will have to submit their
  registration dossier jointly and, consequently, share both the data
  generated for the purposes of registration and the costs associated
  with the generation of data and the registration of the
  substance.

• Evaluation: ECHA and HSE evaluate whether
  registration dossiers are in compliance with the information
  requirements set out in REACH. If they find that the registration
  dossiers are not compliant, they can require the manufacturer or
  the importer to bring the dossier into compliance by generating the
  required information and update the registration dossier. Risks
  posed by registered substances are also screened by Member States
  in the EU and HSE in the UK on the basis of the information
  included in the registration dossier. If it is concluded that the
  substance may pose a risk to human health or the environment that
  needs to be clarified, they can request registrants to generate
  additional data.

• Authorisation: substances (on their own, in
  mixtures or in articles) that are identified as
  “substances of very high concern“
  (“SVHC“) and included in Annex XIV to
  REACH (“the Authorisation List“) cannot
  be placed on the market for a use or be used (including in finished
  products manufactured in the EU/UK), unless a specific
  authorisation is granted. The authorisation requirements do not
  apply to imported articles, meaning that articles manufactured
  outside the EU/the UK and incorporating a substance subject to
  authorisation in the EU/UK can be placed on the EU/UK market.

• Restrictions: When the manufacture, use or
  placing on the market of a substance, on its own, in a mixture or
  in an article, poses an unacceptable risk to human health or the
  environment, it can be restricted by the European Commission. A
  restriction can be any measure necessary to address the
  “unacceptable risk“. Most REACH restrictions ban
  the manufacture, placing on the market and use of substances (above
  specific tolerance levels). However, in some instances restrictions
  impose training or labelling/information requirements.

Who and what does it apply to?

REACH applies to all chemical substances that are manufactured,
placed on the market or used in the EU, whether on their own, in
mixtures (e.g. cosmetics) or finished products (e.g. a laptop, a
bike or a piece of furniture).

Certain exemptions apply. For example:

• REACH does not apply to radioactive substances, substances
  under customs supervision, the transport of substances,
  non-isolated intermediates, waste and some naturally-occurring low
  hazard substances.




• Substances subject to more specific legislation, such as human
  and veterinary medicines, food and feed, plant protection products
  and biocides, have tailored provisions under REACH.

Why does it matter?

REACH is largely seen as one of the most comprehensive and
protective chemicals legislation worldwide. It is taken as a model
by many other countries and has been retained by the UK
post-Brexit.

However, 2023 will be a year of major changes in how chemicals
are regulated on both sides of the Channel.

In the EU, the European Commission is currently drafting a
proposal for the “targeted” revision of EU REACH and is expected to adopt
the proposal at the end of 2023 (see Commission’s 2023 Work Programme). The
proposal was originally scheduled for the end of 2022 and has been
pushed back. It is one of the fundamental pillars of the Chemicals Strategy for Sustainability
(“CSS”), whose objective is to achieve a toxic-free
environment, and its delay is attracting criticism from Member
States, the European Parliament and certain voices in civil
society.

In the UK, the Government has recently introduced to Parliament
the so-called Freedom Bill. If adopted, all retained direct
EU legislation will be revoked by the end of 2023. Retained direct
EU legislation also includes UK REACH. So far, EU REACH has guided
the UK’s post-Brexit approach to the regulation of chemicals.
It is too early to anticipate whether UK REACH will be revoked, but
it is possible that, in the near future, the UK and EU chemicals
regulatory framework will grow further apart, with the consequence
that companies wishing to do business both in the EU and the UK
might be confronted with different regimes to comply with and,
consequently, bear increased regulatory costs.

Where can I find it?

The EU REACH regulation can be found
here.

The REACH etc. (Amendment) Regulations 2021 can be found here. The consolidated version of REACH
incorporating the amendments made by the UK can be found here.

Is there any guidance?

Yes, guidance on different aspects of EU REACH can be found here, here and here.

Guidance on UK REACH can be found here.

The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.