REACH: EU chemicals regime, Practical Law UK Practice Note 7-205-3979 (2018)

REACH: EU chemicals regime

by Practical Law Environment

Practice notes | Maintained | European Union

This note provides a summary of the EU chemicals regime, REACH. REACH stands for the
Registration, Evaluation, Authorisation and Restriction of Chemicals.

Scope of this note

This note summarises the key elements of the REACH regime. For more information on specific
aspects of the regime, see:

0• Practice note, REACH: Enforcement in the UK. There will be a legislative review
process following the UK’s decision to leave the EU (Brexit).
0• Practice note, REACH: Registration.

REACH regime: overview

The REACH regime regulates chemicals in the EU. It has significant cost implications for
manufacturers, importers and downstream users of a wide range of chemicals used in industrial,
commercial and household applications (including chemicals contained in products and articles).

REACH stands for the Registration, Evaluation, Authorisation and Restriction of CHemicals.

The underlying objective of the REACH regime is to ensure that chemicals are used in a way that
minimises unacceptable risks to human health and the wider environment. Sharing information
about the uses and hazards associated with chemicals up and down the supply chain is crucial to
the operation of the regime. Under REACH, the burden of proof for demonstrating that the use of
a chemical does not pose unacceptable risks to human health or the environment will be
transferred from the relevant national authorities to industry.

The REACH regime’s requirements are being phased in over several years (see Timetable for
REACH registration requirements below).

EU legislation and guidance

EU legislation
The REACH Regulation 2006 came into force in June 2007 (Regulation (EC) No 1907/2006 of the
European Parliament and of the Council of 18 December 2006 concerning the Registration,
Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European

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REACH: EU chemicals regime, Practical Law UK Practice Note 7-205-3979 (2018)

Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No
793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and
Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC).

The REACH Regulation 2006 was first published in the Official Journal in December 2006 and was
over 800 pages long. The Regulation was then republished on 29 May 2007 in a different format
but with the same content and now runs to approximately 300 pages. To view the Regulation in
the revised format, see Official Journal 2007 L 136/3. However, please note that the May 2007
version of the REACH Regulation 2006 is not a consolidated version and so needs to be read in
conjunction with any corrigenda and other amendments that have been made since the Regulation
was adopted.

The REACH Regulation 2006 replaced 40 pieces of legislation that comprised the previous
chemicals regime, which was based primarily on Directive 67/548/EEC and Directive 88/379/EEC
(Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and
administrative provisions relating to the classification, packaging and labelling of dangerous
substances and Council Directive 88/379/EEC of 7 June 1988 on the approximation of the laws,
regulations and administrative provisions of the Member States relating to the classification,
packaging and labelling of dangerous preparations).

The REACH Regulation 2006 and its Annexes have been amended a number of times. For an
unofficial consolidated version and information on amending legislation, see ECHA: REACH
legislation.

ECHA: European Chemicals Agency

The REACH regime is regulated at the EU level by the European Chemicals Agency (ECHA).

The Board of Appeal (which is part of ECHA but takes its decision independently) is responsible
for deciding on appeals lodged against certain decisions of ECHA including exemptions and
registrations (see ECHA: The Board of Appeal).

Guidance
The ECHA website is the key starting point for information about REACH and relevant guidance.
See:

0• ECHA: REACH for the main ECHA REACH pages.

0• ECHA: Guidance on REACH for the full suite of ECHA guidance, including detailed
guidance, nutshells (which replace fact sheets) and practical guides on how to comply with
specific REACH obligations.
0• ECHA: Guidance in a nutshell, including summarised guidance for downstream
users as well as on the REACH process.
0• ECHA: Identify your obligations for the REACH Navigator, which is an interactive
online tool to help manufacturers, importers and users to understand their obligations for
individual substances under REACH.

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0• ECHA: Information on Chemicals, which provides “plain English” information about

the hazard profiles of chemicals (see Legal update, REACH: ECHA publishes online chemicals
guide in plain English).
0• ECHA: Chemicals in our life, which provides consumers with information on
chemicals.

Summary of key provisions

Substances under REACH
The REACH regime applies to all chemicals manufactured or marketed in the EU, including
chemicals registered on the European Inventory of Existing Commercial Chemical Substances and
any new chemicals manufactured for the first time.

It applies to substances:

0• On their own.
0• In mixtures.
0• In articles. Note that there has been some debate about the meaning of “article”,
which may result in different enforcement practices in some jurisdictions.

(Article 1(2), REACH Regulation 2006.)

REACH processes
The REACH regime consists of four main limbs:

0• Registration. Registration is the main requirement of REACH. Different

registration requirements apply, depending on the quantity and hazardous nature of a
substance. Manufacturers or importers must submit to ECHA:
0• a registration dossier, if one tonne or more of a substance is manufactured or
imported per year; and
0• a registration dossier and a chemical safety report, if ten tonnes or more of a
substance is manufactured or imported per year.

1• For more information, see Registration below.

0• Evaluation. ECHA and relevant national authorities evaluate substances and
dossiers, to decide whether substances require authorisation or should be subject to
restrictions. For more information, see Evaluation below.
0• Authorisation. Substances listed in Annex XIV of REACH must be authorised for
use. For more information, see Authorisation and SVHCs below.
0• Restrictions. Restrictions may limit or ban the manufacture, placing on the market
or use of a substance, in order to protect human health and the environment from
unacceptable risks. Restrictions might be specific to certain uses of a substance. If this is the
case, the restricted substance can only be used for a use that is not one of the restricted uses.
For more information, see Restrictions below.
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Who has obligations under REACH?

The REACH Regulation 2006 imposes obligations on three main types of persons established in
the EU (referred to in the REACH Regulation 2006 as “actors”):

0• Manufacturers, who manufacture or extract substances.

0• Importers, who import substances or articles into the EU.
0• Downstream users, who use a substance or a mixture as part of their industrial or
professional activities.

The REACH Regulation 2006 also refers to:

0• Producers, who make or assemble articles within the EU.

0• Distributors, who store substances or mixtures and place them on the EU market for
third parties.
0• Suppliers, who can include manufacturers, importers, downstream users, producers
and distributors who put substances, mixtures or articles onto the EU market.

(Article 3.)

Manufacturers and importers are referred to collectively in this note as “suppliers”.

Impact of REACH
The chemicals industry provides raw materials for the manufacture of a vast range of products
(such as plastics, adhesives and sealants, textiles, paints, printing inks, food packaging, cleaning
products and appliances, to name but a few). The effects of REACH on manufacturers, importers
and downstream users are therefore considerable.

The Commission published a report on the experience acquired from the operation of REACH in
February 2013 (see Legal update, REACH: European Commission review concludes no need for
major overhaul of EU Regulation). The Commission concluded that, while some adjustments are
needed, no major overhaul of the regime is required. It proposed reducing the burden for small
and medium-sized enterprises (SMEs) and included a roadmap for identifying and including all
relevant substances of very high concern (SVHCs) in the candidate list by 2020. For more
information on work done in the UK to help SMEs understand the requirements of REACH, see
Implementation and guidance in the UK below.

In March 2018, the Commission adopted its second General Report on the operation of REACH
and a review of certain elements. The second General Report concludes that:

0• There is currently no need for an overhaul of the legislation.

0• There are opportunities for further improvement, simplification and burden
reduction. The report recommends a series of actions to improve the implementation of the
regime.
0• REACH is generally coherent with other EU chemicals legislation and delivers its
international goals as intended.

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(See Legal update, REACH: European Commission adopts second General Report on operation of
REACH and review of certain elements.)

Implementation and guidance in the UK

The REACH Regulation 2006 is directly applicable, meaning that national authorities can require
the relevant parties to comply with the requirements of the REACH regime without member states
having to implement the Regulation into national law.

However, in order to ensure that the relevant national authorities in the UK have the necessary
powers to enforce the REACH regime in full, the UK adopted the REACH Enforcement
Regulations 2008 (SI 2008/2852), which give responsibility for enforcement to the Health and
Safety Executive (HSE), amongst other regulators.

For more information on:

0• Enforcement of the REACH regime in the UK, see Practice note, REACH:
Enforcement in the UK.
0• General guidance on REACH in the UK, see HSE: REACH: Registration, Evaluation,
Authorisation & restriction of CHemicals (REACH).
0• How REACH applies to SMEs, see the guidance produced by the UK Chemicals
Stakeholder Forum UK Chemicals Stakeholder Forum: Guidance for SMEs and downstream
users on REACH authorisation.

Registration
Duty on suppliers to register substances
Suppliers (manufacturers and importers) of substances (including substances in preparations and
articles) in quantities greater than one tonne per year must register those substances with ECHA
(Articles 6 and 7). Registration requires the supplier to submit a dossier containing all relevant
information about each individual use of a substance to ECHA.

Key points to note about registration are:

0• Where a substance is manufactured or imported in excess of ten tonnes per year,

the registration dossier must include a chemical safety report as set out in Annex I to the
REACH Regulation 2006 (Article 14(1), REACH Regulation 2006).
0• A number of substances are exempt from the requirement to register (Article 2,
REACH Regulation 2006).
0• There are special rules for registration of a substance that is manufactured or
imported by several different companies (”one substance, one registration”) (Article 11,
REACH Regulation 2006).

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0• Different deadlines apply for registration, depending on whether the substance is

new or existing (referred to as a “phase-in substance”), its volume and the level of hazard it
poses (Article 23, REACH Regulation 2006) (see Timetable for REACH registration
requirements below).
0• In order to benefit from the longer deadlines for full registration, suppliers of phase-
in substances needed to have pre-registered those substances with ECHA by 1 December
2008 (although there are provisions allowing late pre-registration in certain circumstances)
(Article 28, REACH Regulation 2006). The longer deadlines run from 2010 to 2018 depending
on the tonnage and type of substance.
0• Failure to register means the substance (whether on its own, in mixtures or in
articles) cannot be manufactured, imported or put on the EU market (Article 5, REACH
Regulation 2006).

In January 2015, ECHA published its REACH 2018 Roadmap, which describes the different
milestones and the support services that ECHA plans to give to the registrants until the deadline.
ECHA expects up to 70,000 registrants, with many more being inexperienced small and medium-
sized enterprises (SMEs) from outside the chemical sector (see Legal update, ECHA publishes
REACH 2018 Roadmap).

In March 2015, ECHA published clarification on how companies can report on the use of
substances in hydraulic fracturing (shale gas fracking) in their registration dossiers (see Legal
update, REACH: ECHA clarifies how to report on substances used in shale gas fracking).

Further reading on registration

For more information on registration, see:

0• Practice note, REACH: Registration.

0• ECHA: Registration.
0• ECHA: Registered substances for a database of registered substances.

What happens to a registration on an asset transfer?

Registrations may be transferred from one legal entity to another following an asset transfer, as
long as the company provides evidence of the transfer, such as the asset sale agreement (see
Legal update, ECHA reverses asset transfer policy under REACH). ECHA has published ECHA:
Practical guide 8: How to report changes in identity of legal entities (2010), which gives detailed
guidance on asset transfers, change of name and change of control of companies that have REACH
registrations.

SIEFs
If more than one person has submitted information as part of the pre-registration or registration
of the same substance, then there is an obligation to participate in a Substance Information
Exchange Forum (SIEF) (Article 29, REACH Regulation 2006). In some cases, participating in a

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SIEF may require parties to share potentially commercially sensitive information.

For more information on SIEFs, see Practice note, REACH: Registration: Data-sharing, SIEFs and
consortia.

ECHA enforcement action on registrations

Although ECHA is not an enforcing authority itself, its work has a significant bearing on
enforcement as it can reject registrations of substances, resulting in the continued manufacture,
importation or supply of those substances becoming illegal.

In June 2017, ECHA announced that it had revoked four registrations under the REACH regime.
Three of the registrations were revoked for being incomplete. One was in breach of the “one
substance, one registration” rule, which requires the registration dossier to be a joint submission
for a substance, made by a lead registrant on behalf of all suppliers of that substance (see
Practice note, REACH: Registration: Joint submission of information). For more information, see
Legal update, European Chemicals Agency revokes four chemical substances registrations in
REACH enforcement action).

Evaluation
Overview of evaluation processes
Evaluation is the process by which ECHA and the relevant national authorities decide whether
further testing and information about a substance is needed. This process also allows ECHA and
the national authorities to decide whether the substance in question requires an authorisation or
whether restrictions should be imposed.

There are three types of evaluation done under REACH:

0• Compliance check of dossiers. ECHA will review roughly 5% of the technical

dossiers in each tonnage band that are submitted at registration (Article 41, REACH
Regulation 2006). The aim is to encourage registrants to comply with the information
requirements under REACH. ECHA can request further information if it considers that a
dossier is not compliant with REACH requirements.
0• Evaluation of testing proposals. ECHA reviews the testing proposals submitted
by registrants to check that reliable and adequate data will be produced and to prevent
unnecessary animal testing (Article 40, REACH Regulation 2006). Following publication of the
proposal and any comment by third parties, ECHA can accept, modify or reject the testing
proposals or require different tests to be done.
1• In November 2015, ECHA announced that it is requesting additional information
from registrants who submit new testing proposals for vertebrate animal tests, to ensure that
animal testing is only done as a last resort. The announcement follows a September 2015
decision by the European Ombudsman on a case about how ECHA applies rules on animal
testing (see Legal update, REACH: ECHA requests more information from registrants who

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submit animal testing proposals).

0• Substance evaluation. The relevant national authorities in member states (the
HSE in the UK) evaluate certain higher risk substances to decide whether their use poses a
risk to human health or the environment (Articles 44-48, REACH Regulation 2006) (see
Substance evaluation below).

For more information on evaluation in general, see ECHA: Evaluation.

Substance evaluation
ECHA is required to publish a Community Rolling Action Plan (CoRAP), listing the substances that
need to be evaluated over a three year period and allocating responsibility for evaluation to
specific member states (Article 44(2)). ECHA updates the CoRAP annually. The substances
included in the CoRAP are selected based on risk criteria defined by ECHA.

The relevant authorities in member states have to carry out the evaluation within one year from
the date the CoRAP was published (Article 46(1), REACH Regulation 2006). If necessary, member
states must then prepare a draft decision requesting the registrant to submit further information
to clarify any possible risk. The final decision is taken by ECHA, after consultation. Alternatively, if
the member state considers that the risks are sufficiently controlled by existing measures, no
further information or action is required. Following assessment of any further information
submitted, the member state may propose that:

0• Additional further information is provided by the registrant.

0• The substance should be authorised.
0• EU-wide or national risk management measures need to be introduced (for example,
restrictions or occupational exposure limits).
0• No further action is necessary.

The first CoRAP was published in February 2012 for the period to March 2014 (see Legal update,
REACH: ECHA publishes plan with first list of substances for evaluation). The CoRAP is updated
every year in March.

For more information on:

0• Substance evaluation, see ECHA: Substance Evaluation.

0• The CoRAP, see ECHA: Community rolling action plan.

Authorisation and SVHCs

SVHCs: substances of very high concern
Substances that are listed as substances of very high concern (SVHCs) in Annex XIV (the
Authorisation List) cannot be placed on the market or used unless:

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0• They are authorised for the specific use.

0• The use is exempted from authorisation.

(Article 56.)

SVHCs are divided into four broad categories, namely substances that:

0• Are carcinogenic, mutagenic or toxic to reproduction (CMRs).

0• Are persistent, bio-accumulative and toxic (PBTs).
0• Are very persistent and very bio-accumulative (vPvBs).
0• Give rise to similar concerns as CMRs, PBTs and vPvBs (such as endocrine
disruptors).

The full criteria for identifying an SVHC are set out in Article 57. Annex XIII to the REACH
Regulation 2006 sets out the specific criteria for the identification of PBT and vPvB substances.

The identification of substances as SVHCs and their inclusion in the REACH Candidate List (the
list of substances that may need to be included on the Authorisation List) is the first step in the
procedure for authorisation of substances under the REACH regime. SVHCs will be included
gradually in the Authorisation List (Annex XIV). Once included in the Authorisation List, those
substances cannot be placed on the EU market or used in the EU after a date to be set, unless the
company has been granted an authorisation (see Steps in the authorisation process below).

In 2010, the Commission committed to have all currently known SVHCs included in the Candidate
List by 2020. In February 2013, the Commission and ECHA drew up a roadmap for achieving this
aim (see Legal update, REACH: European Commission adopts Roadmap on substances of very
high concern).

Scope of SVHCs concept

In April 2015, the General Court (EU) gave its judgment in the joined cases of Polynt SpA v
European Chemicals Agency (ECHA) (Cases T-134/13 and 135/13) [2015] EUECJ T-134/13 (30
April 2015). The General Court upheld ECHA’s 2012 decision to list seven substances classified as
respiratory sensitisers on the Candidate List of SVHCs.

These substances could be included on the Candidate List even though they did not fall within the
CMR, PBT or vPvB categories of SVHCs specified in Article 57 of the REACH Regulation 2006. The
category of SVHCs in Article 57(f) was not limited by references in it to endocrine disruptors,
PBTs or vPvBs. In other words, ECHA is not bound by the existing categories of SVHCs when
considering whether to include a new substance in the Candidate List. As a result, it may become
more difficult for the chemicals industry to predict if a substance that does not fall within the
existing categories is likely to be included in the Candidate List and, ultimately, in the
Authorisation List in Annex XIV (see Legal update, REACH: scope of substances of very high
concern extended (General Court (EU))).

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Steps in the authorisation process

Step 1: Identification of SVHCs by the authorities

ECHA or member states’ competent authorities propose that a particular substance be included in
the Candidate List (Articles 59(1) and (2)).

Interested parties can comment on the proposal (Article 59(4), REACH Regulation 2006). If no
comments are received, the substance is included in the Candidate List. If comments are received,
the matter is referred to ECHA’s Member State Committee. If the Committee unanimously agrees
that the substance in question meets the criteria in Article 57, the substance is included in the
Candidate List. If the Committee fails to reach unanimous agreement, the Commission decides.

Companies may have immediate legal obligations following inclusion of a substance in the
Candidate List (see ECHA: Summary of obligations resulting from inclusion in the Candidate List
of Substances of Very High Concern for authorisation).

ECHA publishes information about SVHCs in some consumer articles (see ECHA: Introduction to
information on Candidate List substances in articles).

For more information on the Candidate List, see ECHA: Candidate List of Substances of Very High
Concern for authorisation. It is possible to be informed when new substances are added to the
Candidate List by subscribing to ECHA’s press releases, news alerts and web updates (see ECHA:
Press Releases: News).

Step 2: Recommendation process by the authorities

The substances in the Candidate List are prioritised in order to determine which ones should be
included in the Authorisation List (that is, added to Annex XIV to the REACH Regulation 2006).

ECHA prepares a draft recommendation and consults on it. The draft recommendation must
include, among other things:

0• An “application date” (the date at least 18 months before the sunset date by which
applications must be received if the applicant wishes to continue to use the substance or
place it on the market after the sunset date).
0• A “sunset date” (the date from which placing on the market and use of the
substance is prohibited, unless an authorisation is granted).
0• Uses or categories of uses exempted from the authorisation requirement (if any).

ECHA updates the recommendation in light of the results of the consultation and the opinion of
the Member State Committee, and submits the final recommendation to the Commission, who
decides whether the recommended substances should be included in Annex XIV. Annex XIV is then
amended (by Commission Regulation) to include the additional SVHCs.

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It is possible to be informed when new substances are added to the Authorisation List by
subscribing to ECHA’s press releases, news alerts and web updates (see ECHA: Press Releases:
News).

For more information on the Authorisation List, see:

0• ECHA: Submitted recommendations, which lists the recommendations from the

ECHA for substances on the Candidate List to be added to Annex XIV.
0• ECHA: Authorisation List, which lists the substances on the Authorisation List and
the latest application date and sunset date for each substance.

Step 3: Applications for authorisation by industry

Once included in the Authorisation List (Annex XIV), those substances cannot be placed on the EU
market or used in the EU after a date to be set, unless the Commission has granted an
authorisation.

Manufacturers, importers or downstream users of a substance on the Authorisation List can apply
for authorisation (Article 62).

Applications for authorisation need to be made by the application date and must include, among
other things:

0• A chemical safety report.

0• An analysis of possible alternative substances or technologies. If the analysis of
alternatives reveals that there is a suitable alternative, the applicant must submit a
substitution plan, explaining how he intends to replace the substance by the alternative.

Applications for authorisation are subject to public consultation and are considered by two ECHA
committees (Article 64(4), REACH Regulation 2006).

In April 2013, ECHA clarified the timing for submitting an application for an authorisation (see
Legal update, REACH: clarification on when to submit applications for authorisation). ECHA
confirmed that if the application is submitted before the latest application date, the applicant can
continue to use the substance after the sunset date, while waiting for the Commission’s decision.
ECHA says that, in practice, this clarification means that applications can be submitted three
months later than previously.

For more information on applications for authorisation, see ECHA: Applications for authorisation.

Step 4: Granting of authorisations by the Commission

The Commission grants the authorisation if the applicant can demonstrate that the risk from their
use of the substance is adequately controlled (Article 60(2)).

If the applicant cannot demonstrate that the risk is adequately controlled, the Commission may

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still grant an authorisation if the applicant can show that the socio-economic benefits outweigh the
risks, and that there are no suitable alternatives (Article 60(4), REACH Regulation 2006).

When an authorisation is granted for a substance:

0• The person holding the authorisation must include the authorisation number on the
label of the substance before placing it (or the mixture containing it) on the market ( Article
65, REACH Regulation 2006).
0• The person holding the authorisation and any users of the substance must comply
with any requirements set out in the authorisation decision.
0• Users of the substance must notify ECHA if they use the substance, within three
months of the first supply of the substance. ECHA keeps a register of notifications, which
member states’ competent authorities can access (Article 66(1)).

Authorisations are subject to review:

0• By the date set out in the particular authorisation decision (Article 60(8)).
0• At any time, if the circumstances of the authorised use change to affect the risks or
the socio-economic impact, or if new information on alternatives becomes available (Article
61(2)).

Substances on the Candidate List

In June 2017, the Member State Committee (MSC) of ECHA unanimously agreed to identify 4,4’-
isopropylidenediphenol (bisphenol A, BPA) as an SVHC. ECHA had already listed BPA in the
Candidate List because of its toxic to reproduction properties but France proposed this change,
due to BPA’s endocrine disrupting properties for human health, which are probably carcinogenic,
mutagenic, and toxic to reproduction. ECHA has updated the Candidate List entry for BPA(see
Legal update: REACH: ECHA adds bisphenol A (BPA) to the candidate list).

Exemptions from authorisation

There are some generic exemptions from the authorisation requirement. These include use of
substances in the following (provided certain conditions are met):

0• Medicines.
0• Food.
0• Fuel for vehicles or combustion plants.
0• Pesticides and biocidal products.
0• Scientific research and development.

(Article 56.)

For more information on generic exemptions, see the guidance for downstream users at ECHA:
Guidance Documents.

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In addition, ECHA may propose exemptions for specific substances or specific uses, if other EU
legislation provides proper control of the risks and protection of human health and the
environment. These will be set out in the recommendations for authorisation submitted by ECHA
to the Commission.

Publication of authorisation documents

In January 2017, the General Court (EU) rejected a challenge by an applicant for authorisation of
the ECHA’s decision to disclose documents relating to its application for authorisation of DEHP
(an endocrine disruptor) (Deza v ECHA [2017] EUECJ T-189/14).

The court held that:

0• Disclosure of information on the risk characterisation of DEHP (including chemical

safety reports, full exposure scenarios and the analysis of alternatives) was essential to allow
the public to understand the risks of using DEHP.
0• Commercially valuable information is not to be automatically considered as
confidential information.

In an email exchange with Practical Law Environment, ECHA indicated that the level of detail that
is made available as part of public consultations on REACH authorisations has increased following
this judgment.

For more information see, Legal update: REACH: ECHA can publish authorisation documents on
endocrine disruptors (General Court (EU)).

Proposed simplified authorisation procedure

In February 2015, the Commission published a consultation seeking views on:

0• Simplifying the procedure for applying for authorisation for uses of SVHCs in low
volumes. The simplified application procedure would only be available where there is no
potential for consumers to be exposed to the SVHC in question.
0• Extending transitional arrangements for uses of SVHCs in legacy spare parts,
pending introducing a simplified application procedure for authorisation.

For more information, see Legal update, European Commission consults on simplifying REACH
chemicals regime for low volumes of substances and spare parts.

In October 2015, the European Commission adopted its Work Programme for 2016, which
(amongst other things) proposed changes to the REACH authorisation procedure (see Legal
update, European Commission Work Programme 2016: environmental aspects).

Further reading on authorisation

0• See ECHA: Authorisation.

Duty to notify ECHA and provide information to consumers about articles containing
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SVHCs
Producers or importers of articles must notify ECHA where an SVHC is present in articles both:

0• In quantities totalling over one tonne per producer or importer per year.
0• Above a concentration of 0.1% weight by weight (w/w).

(Article 7(2).)

Suppliers are under a duty to provide information to consumers on SVHCs in articles (Article 33).
The duty applies where an article contains an SVHC in a concentration above 0.1% w/w and the
supplier must provide sufficient information to allow safe use of the article to:

0• The recipient of the article.

0• A consumer who requests that information

As a minimum, the information supplied should include the name of the substance.

Fédération case: obligation to notify SVHCs extends to component parts

In Fédération des entreprises du commerce et de la distribution (FCD), Fédération des magasins
de bricolage et de l’aménagement de la maison (FMB) v Ministre de l’Écologie, du Développement
durable et de l’Énergie (Case C- 106/14) (10 September 2015), the ECJ decided that the SVHC
notification and information obligations that apply to producers, importers and suppliers apply in
relation to each component part of a complex product, rather than just the finished product.

This is because, while the REACH Regulation 2006 gives a basic definition of “article”, it does not
contain provisions specifically governing the situation of a complex product containing several
articles. The ECJ’s decision reverses the Commission and ECHA guidance on these obligations and
places a significant new regulatory burden on producers, suppliers and retailers, particularly
those with complicated supply chains (see Legal update, REACH: supplier obligations for
substance of very high concern (SVHCs) apply to components as well as finished product (ECJ)).

In July 2016, ECHA consulted on new draft guidance on substances in articles to provide updated
guidance following the Fédération decision. Revised guidance was published in June 2017 (see
ECHA: Guidance on requirements for substances in articles).

Restrictions
Restrictions on certain substances
The manufacture, importation or use of certain substances may be restricted or banned (for
example, asbestos) (Article 67). The restricted substances are listed in Annex XVII to the REACH
Regulation 2006, which has been amended a number of times (see Commission: Restrictions for
the amendments to Annex XVII).

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The procedure for amending Annex XVII to introduce restrictions on a substance is as follows:

0• If a member state or ECHA (following a request by the Commission) is concerned

that a substance poses an unacceptable risk to human health or the environment, it can
prepare a restriction proposal.
0• Notice of the intention to prepare a restriction proposal is published in the Registry
of Intentions.
0• Annex XV sets out how the registration proposal should be prepared. It must be
submitted to ECHA within 12 months of notification of the intention to prepare the proposal.
0• There is a public consultation on the registration proposal and supporting
information.
0• Two ECHA committees will consider the proposal and consultation responses and
give their opinions.
0• The Commission prepares a draft amendment of Annex XVII, which is considered
and approved under the comitology procedure. For more information on the comitology
procedure, see Practice note: overview, Regulatory procedure with scrutiny (comitology).

(Articles 68-73, REACH Regulation 2006.)

0• For more information on restriction, see ECHA: Regulations - Restriction.

UK derogation for second-hand articles containing asbestos

In November 2013, a derogation on the marketing and use of second-hand articles containing
asbestos was introduced in the UK, through the REACH Enforcement (Amendment) Regulations
2013 (SI 2013/2919) (see Legal update, UK REACH regulations allow sale of second-hand articles
containing asbestos). This followed a July 2013 consultation (see Legal update, Government
consults on marketing and use of second-hand articles containing asbestos).

EU case law on restrictions

ECJ dismisses challenge to acrylamide restriction

In February 2013, the ECJ dismissed an application to annul an amendment of Annex XVII to the
REACH Regulation 2006 that restricts the use of acrylamide and related substances (Regulation
(EU) No 366/2011 amending Regulation No 1907/2006 as regards Annex XVII (Acrylamide)) (see
Legal update, REACH: ECJ dismisses challenge to restrictions on acrylamide).

This case will be of interest to anyone considering bringing a challenge under REACH. The
judgment contains a very detailed discussion of the law relating to the various pleas, and the
REACH assessment process for acrylamide. However, this case contains no new law.
(Polyelectrolyte Producers Group, SNF SAS and Travetanche Injection SPRL v European
Commission supported by Kingdom of the Netherlands (Case T- 368/11) [2013].)

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ECJ considers interaction of Waste Framework Directive and REACH for end-of-waste and
substances subject to REACH restrictions

In March 2013, the ECJ gave its decision in a case relating to the re-use of wood that had been
treated with an arsenic compound subject to restrictions under Annex XVII (Lapin elinkeino ..., v
Lapin luonnonsuojelupiiri ry [2013] EUECJ C-358/11 (07 March 2013)). The court commented on:

0• The interaction between the REACH Regulation 2006 and the Waste Framework
Directive 2008 (Directive 2008/98/EC of the European Parliament and of the Council of 19
November 2008 on waste and repealing certain Directives).
0• How end-of-waste should be determined for a particular type of waste, if the
Commission has not laid down specific end-of-waste criteria.

The ECJ also decided that the Waste Framework Directive 2008 does not exclude the possibility
that hazardous waste may cease to be waste. However, it said that it was for the national court to
determine whether or not this had occurred for a particular type of waste, based on whether the
relevant requirements of the REACH Regulation 2006 and the Waste Framework Directive 2008
had been met. In particular, it was for the national court to decide whether the conditions for a
derogation from the Annex XVII restrictions had been met.

For more information, see Legal update, ECJ considers interaction of Waste Framework Directive
and REACH Regulation for end-of-waste.

Duty on suppliers to provide safety data sheets

Suppliers of substances and of mixtures that meet specified criteria must prepare safety data
sheets (SDSs) and provide them to the recipients of those substances and mixtures (Article 31(1)).

SDSs provide information about substances to enable users to make a risk assessment and handle
the substance safely. Annex II to the REACH Regulation 2006 sets out the requirements for
compiling SDSs.

The requirements for compiling SDSs changed in December 2010 and June 2015 (Commission
Regulation (EU) No 453/2010 of 20 May 2010 amending Regulation (EC) No 1907/2006 of the
European Parliament and of the Council on the Registration, Evaluation, Authorisation and
Restriction of Chemicals (REACH)) (see Legal update, REACH: new requirements for safety data
sheets). The main purpose of the changes was to bring SDSs in line with the CLP Regulation 2008
(Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification,
labelling and packaging of substances and mixtures, amending and repealing Directives
67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006).

The Safety Data Sheet Regulation 2015 inserted a new Annex II into the REACH Regulation 2006
to consolidate otherwise conflicting amendments that were made to Annex II in 2008 and 2010,
which both would have taken effect from 1 June 2015 (Commission Regulation (EU) 2015/830 of
28 May 2015 amending Regulation (EC) No 1907/2006 of the European Parliament and of the
Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)) (see
Legal update, REACH: new Regulation consolidates and clarifies requirements for preparing
safety data sheets). Operators were required to use the new Annex II set out in the Safety Data

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Sheet Regulation 2015 to compile SDSs from 1 June 2015. However, to avoid a disproportionate
regulatory burden, SDSs prepared before 1 June 2015 could be used until 31 May 2017.

Suppliers must provide a SDS for the following:

0• A substance (and, from 1 June 2015, a mixture) classified as hazardous under the
CLP Regulation 2008.
0• A substance that is PBT or vPvB under Annex XIII to the REACH Regulation 2006.
0• A substance that is included in the Candidate List of SVHCs.

(Article 31(1).)

In certain circumstances, mixtures that do not meet the criteria for classification as dangerous or
hazardous also require a SDS (Article 31(3)).

Suppliers must provide updated SDSs to anyone to whom they have supplied the substance or
mixture within the previous year, if one of the following occurs:

0• New hazard information or information that may affect how risks are managed
becomes available.
0• A substance is authorised under REACH.
0• A restriction is imposed on a substance under REACH.

(Article 31(9).)

For more information, see:

0• ECHA: Safety Data Sheets.

0• ECHA: Guidance on the compilation of safety data sheets (November 2015).
0• ECHA: Guidance in a nutshell: Compilation of safety data sheets (December 20135).

Downstream users
Downstream users are companies or individuals who use a chemical substance, either on its own
or in a mixture, in the course of their industrial or professional activities.

They are subject to a number of obligations, mostly under Titles IV (Information in the supply
chain) and V (Downstream users) of the REACH Regulation 2006.

Downstream users’ main obligations are to:

0• Provide information regarding uses of substances to suppliers. This is so that the

supplier can include relevant information in the registration dossier it must submit to ECHA.
0• Produce their own dossier and risk assessments, and register the relevant
information with ECHA, if the necessary information has not been covered in a supplier’s
registration dossier.

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0• Implement safety and risk management measures specified by suppliers (including

information in SDSs), and pass information about safe use on to customers.
0• Inform suppliers if they have new information on the hazards of the substance.
0• Comply with authorisation conditions or restrictions.

For more information, see:

0• Article, Impact of REACH on downstream users.

0• ECHA: Guidance for downstream users (October 2014).
0• ECHA: Guidance in a nutshell: Downstream users (December 2013April 2017).

Timetable for REACH registration requirements

The requirements in the REACH Regulation 2006 are being phased in gradually:

1 June - 1 December 2008 Pre-registration of phase-in substances (subject

to late pre-registration provisions) (Article 28).

30 November 2010 Deadline for registration of:

0• Substances of 1,000 tonnes or more per

year (Article 23(1)(c)).
0• CMRs of one tonne or more per year
(Article 23(1)(a)).
0• Substances of 100 tonnes or more per year
that are classified as very toxic to the
aquatic environment (Article 23(1)(b)).

31 May 2013 Deadline for registration of substances of 100

tonnes or more per year (Article 23(2)).

31 May 2018 Deadline for registration of substances of 1

tonne or more per year (Article 23(3)).

Extension of REACH to mixtures of chemicals

In May 2012, the Commission announced that it would use the REACH regime to control certain
uses of chemical mixtures, where appropriate (Commission: Communication COM(2012) 252 on
the combination effects of chemicals: chemical mixtures (May 2012)). The Commission stated that

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it would:

0• Consider if regulation is required for certain chemical mixtures that have

unintended consequences.
0• Develop technical guidance to codify best practice for the assessment of priority
mixtures by 2014 and report on progress made in 2015.

For more information, see:

0• Legal update, European Commission announces new approach to chemical

mixtures.
0• Commission: Combination effects of chemicals.

The Commission’s 7th Environmental Action Plan states that the EU will develop and implement
approaches to address the combination effects of chemicals in relevant legislation by 2020 (see
Legal update, EU environment policy priorities to 2020: General Union Environment Action
Programme to 2020 published in Official Journal).

Extension of REACH to nanomaterials

The Commission considers that REACH and CLP provide the best possible framework for
managing risks from nanomaterials that occur as substances or in mixtures. However, it also
considers that clearer REACH requirements for nanomaterials are necessary to ensure that
industry demonstrates safe use.

In June 2013, the Commission consulted on changes to the technical Annexes to the REACH
Regulation 2006 for the registration of nanomaterials (see Legal update, European Commission
consults on nanomaterials under the REACH regime).

In January 2016, the Commission published a Roadmap on the possible amendments of the
REACH Annexes. The Commission has identified a need for more specific requirements for
nanomaterials to ensure further clarity on how nanomaterials are addressed and safety
demonstrated in registration dossiers in order to achieve the aims of REACH. The Roadmap sets
out several possible options for new measures (see Legal update, REACH: European Commission
publishes Roadmap on possible amendments of Annexes to REACH for registration of
nanomaterials).

In October 2017, the Commission published a consultation on a draft Regulation to amend several
Annexes to the REACH Regulation 2006. The amendments clarify registration duties and
downstream user obligations relating to nanomaterials (see Commission: Amendments of the
Annexes to REACH for registration of nanomaterials (9 October 2017)).

For more information on nanomaterials, see Practice note, Nanotechnology and nanomaterials.

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Interaction between REACH and EU Cosmetics Regulation 2009

In October 2014, the Commission and ECHA published clarification on how the ban on animal
testing in the EU Cosmetics Regulation 2009 interacts with the need to provide information under
the REACH regime about the hazards associated with certain substances (Regulation (EC) No
1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic
products (recast)).

The testing and marketing bans in the Cosmetics Regulation 2009 do not apply to the testing
required for environmental endpoints, exposure of workers and non-cosmetic uses of substances
under the REACH regime. However, where a substance is registered exclusively for cosmetic use,
the registrant will still have to provide the required information under the REACH regime
wherever possible, by using alternatives to animal testing (such as computer modelling, read-
across and weight of evidence).

For more information, see ECHA: Clarity on interface between REACH and the Cosmetics
Regulation (27 October 2014).

Interaction between chemicals and waste legislation

The Commission has recognised that the presence of chemicals in products can either prevent
recycling or mean that restrictions or prohibitions apply because those chemicals are hazardous.
For more information on the Commission’s work on this issue, see Practice note, Circular
economy: EU and UK initiatives: Roadmap on interface between chemicals, products and waste
legislation.

Impact of Brexit on the UK chemicals industry

In April 2017, the House of Commons Environmental Audit Committee (EAC) published its report
on the future of chemicals regulation after the EU referendum. Key findings include that:

0• The REACH Regulation 2006 is difficult to transpose directly into UK law and cannot
be achieved by provisions in the Great Repeal Bill (now known as the European Union
(Withdrawal) Bill 2017-19) deeming REACH to apply in the UK. This is because REACH
assumes that participants are within the EU and depends on the co-operation and mutual
obligations of member states and on access to the ECHA’s database of chemical properties.
0• The government must urgently provide certainty to the UK chemicals industry over
the future of chemicals regulation. UK companies will have spent an estimated £250 million
to comply with the REACH deadline in May 2018 for registration of smaller quantities of
substances. The government must urgently clarify the future regulatory framework and
whether these registrations will remain valid once the UK leaves the EU in 2019. This
uncertainty may already be having an impact on long-term investment decisions by
companies.
0• Most respondents wanted to stay as closely aligned to REACH as possible.

For more information, see Legal update, Environmental Audit Committee publishes report on

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future of chemicals regulation after Brexit.

In September 2017, the EAC published an Appendix containing the government’s response to its
April 2017 report on the future of chemicals regulation after the EU referendum. The response,
which largely reiterates the evidence that the government provided to the EAC during its inquiry
earlier in 2017, states that:

0• Whether a stand-alone system of chemicals regulation for the UK needs to be

established will be affected by many factors, including the negotiations, and cannot be pre-
judged.
0• The government is reviewing how chemicals are regulated in a number of non-EU
countries to determine the options for developing the UK’s regulatory regime in the longer
term.

(See Legal update, Government response to Environmental Audit Committee report on future of
chemicals regulation after Brexit.)

Also in September 2017, the EAC called for further written submissions on the government’s
response (see Houses of Parliament press releases, Government response prompts further call for
views, 29 September 2017).

In January 2018, the Commission published a notice setting out the consequences of Brexit for
“economic operators” (manufacturers, importers, distributors and authorised representatives
(ARs)) who place non-food and non-agricultural products on the EU market.

Subject to any transitional arrangements, the UK will become a “third country” upon Brexit and
will no longer be subject to EU rules. The notice highlights that:

0• Upon Brexit, EU-based economic operators that sell UK products will become
importers, as opposed to distributors and will be subject to importers’ obligations, which are
different from those of distributors.
0• ARs and responsible persons established in the UK and appointed by manufacturers
under certain EU laws will no longer be recognised under EU law upon Brexit. Manufacturers
will need to ensure that their ARs and responsible persons are established in the EU. For
information on the appointment of only representatives by non-EU manufacturers under
REACH, see Practice note, REACH: Registration: Non-EU legal entities and only
representatives.
0• Upon Brexit, UK Notified Bodies (such as the British Standards Institution) that are
required under EU laws for some products will no longer be recognised.

(see Legal update, European Commission publishes notice on consequences of Brexit for
distributors and manufacturers.)

In April 2018, the Confederation of British Industry published a report collating the views of a
number of trade associations on the future of the rules that will govern the UK economy after the
transition period following Brexit (see Legal update, Brexit: CBI report on the future of UK
regulation). Owing to how closely chemical supply chains in the UK and EU are integrated, the

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report recommends that convergence between the UK and EU on chemicals regulation is

essential. If the transition period ends without convergence being agreed, the report states that:

0• Any chemicals manufactured in the UK would no longer be allowed to be used in the

EU as their registration and, where relevant, authorisation under REACH would no longer be
valid. Customers of UK chemicals businesses would, therefore, need to either find a
replacement supplier within the remaining EU members states or to take on the necessary
registration or authorisation themselves.
0• As registration and authorisation applications under REACH can take two to three
years, UK-based companies are now too late to complete these processes to ensure that the
chemicals they make can continue to be used in the EU without interruption.
0• UK-based companies would have to set up EU offices, appoint an only representative
based in a remaining EU member state to re-register their substances or, in the case of
authorisation, rely on a customer to apply for authorisation themselves. In any scenario,
reregistration and reauthorisation would be a duplication of work that has already been done
to register and authorise substances.

The House of Lords EU Energy and Environment Sub-Committee is considering the future of
REACH post-Brexit. In June 2018, the Committee heard oral evidence from a number of industry
experts (see HoL: Select Committee on the European Union Energy and Environment Sub-
Committee oral evidence: The future of REACH regulations post-Brexit (27 June 2018)). Several
issues were discussed including:

0• The potential invalidity of UK company REACH registrations or authorisations post-

Brexit and the impact that could have on supply chains.
0• Whether and how UK companies will be able to continue to use data on chemicals
that they have submitted as part of registration dossiers outside of the REACH regime.
0• How any arrangements that the UK puts in place to mirror REACH would connect to
the REACH regime?

In September 2018, the National Audit Office (NAO) published its second report on the
Department for Environment, Food & Rural Affairs’ (Defra’s) progress on implementing the UK’s
EU exit. The report concludes that Defra has done well in very difficult circumstances although it
also expresses several concerns, including that government restrictions have prevented Defra
from supporting businesses in the chemicals industry in their preparations for a no-deal Brexit
(see Legal update, NAO reports concern over Defra’s Brexit preparations).

Also in September 2018, the House of Commons Library published a briefing paper which looks at
what could happen if the EU and UK negotiators do not conclude a withdrawal agreement before
the UK’s exit from the EU on 29 March 2019 (See House of Commons Library: What if there’s no
Brexit deal (10 September 2018)). The briefing paper identifies how UK companies will be able to
export chemicals to the EU if registrations are invalid in the EU market and how chemicals will be
regulated in the UK without REACH as among the key impacts of a no-deal Brexit. The paper
provides a helpful summary of these issues and the current information on the government’s plans
to address them. The report states that two of the main challenges to setting up a UK REACH
include:

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REACH: EU chemicals regime, Practical Law UK Practice Note 7-205-3979 (2018)

0• Establishing a regulatory authority in the UK to perform the functions currently

carried out by the ECHA.
0• Setting up a UK database of registered substances that would effectively replicate
the ECHA system.

(See Legal update, Brexit: House of Commons Library publishes briefing paper on no-deal Brexit.)

For more information on the impact of Brexit:

0• More generally, see Practice note, Brexit: the effect on environmental law.
0• On the REACH regime, see ECHA: The UK’s withdrawal from the EU.

CLP regime: classification, labelling and packaging of

substances
The REACH Regulation 2006 sits alongside the CLP Regulation 2008 (Regulation (EC)
No 1272/2008 of the European Parliament and of the Council on classification,
labelling and packaging of substances and mixtures, amending and repealing
Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No
1907/2006).

The CLP Regulation aligns the EU regime for the classification, labelling and
packaging of chemicals with the United Nation’s Globally Harmonised System (GHS)
of classification criteria and labelling requirements, so that the same hazards can be
described and labelled in the same way globally.

For more information, see Practice note, CLP: classification, labelling and packaging of
chemical substances regime: How does CLP interact with the REACH regime?.

Prior informed consent for export and import of

hazardous chemicals
The EU PIC Regulation 2012 implements and extends the requirements in the EU of
the Rotterdam Convention on the Prior Informed Consent Procedure for certain
hazardous chemicals and pesticides in international trade (Regulation (EU) No
649/2012 of the European Parliament and of the Council of 4 July 2012 concerning the
export and import of hazardous chemicals). It applies from 1 March 2014, when it
repealed the PIC Regulation 2008 (Regulation (EC) No 689/2008 of the European

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Parliament and of the Council of 17 June 2008 concerning the export and import of
dangerous chemicals).

The PIC regime administers the import and export of certain hazardous chemicals and
places

obligations on companies who wish to export these chemicals to non-EU countries. The
main requirements are:

0• EU exporters must notify their intention to export chemicals listed in

Annex I to a country outside the EU. This is the export notification procedure.
0• Export of Annex I chemicals from an EU member state to a non-EU
member state also requires explicit consent from the designated national
authority of the importing non-EU country. These are the explicit consent
requirements. An explicit consent lasts three years. During that period, any
company in the EU may export the same chemical to the country that has granted
the explicit consent.
0• Chemicals listed in Annex V are banned from export to non-EU
countries.
0• All chemicals that are exported have to comply with rules on packaging
and labelling under the CLP regime and any other relevant EU legislation.

For more information, see:

0• Legal update, Recast PIC Regulation on international trade in chemicals

published in Official Journal.
0• ECHA: Prior Informed Consent Regulation.
0• ECHA: Guidance on PIC.

Further reading
0• Commission: REACH - Registration, Evaluation, Authorisation and
Restriction of Chemicals.
0• ECHA.

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REACH: EU chemicals regime, Practical Law UK Practice Note 7-205-3979 (2018)

0• HSE: REACH.
0• Chemical Industries Association.
0• REACHReady. This is a company set up by the Chemical Industries
Association to help industry and businesses in the UK understand and comply
with the REACH regime.
0• Chemical Business Association.
0• European Chemical Industry Council (CEFIC). CEFIC has produced a
number of helpful guidance notes and model legal agreements, including model
SIEF agreements and data sharing agreements (see CEFIC: REACH guidance and
tools).

END OF
DOCUMENT

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