IMPLICATIONS OF REACH ON CHEMICALS SAFETY AND MANAGEMENT

1. REACH INTRODUCTION

REACH is a regulation that governs the Registration, Evaluation, Authorization and Restriction of
Chemical substances in the EU.
REACH stands for the:
Registration
Evaluation
Authorization and restriction of
Chemicals
Its full title is Regulation (EC) no 1907/2006 of the European Parliament and of the Council
concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH).
REACH is intended to provide an encompassing regulatory framework that enables information
production and decision-making relating to all chemicals produced and/or circulating in the EU
market, covering every stage of the chemicals production and use cycle. The information allows
identification of dangerous chemicals, a cost-effective assessment of the risks posed by the
production, marketing, use, and disposal of such chemicals, and the development of cradle-to-grave
risk management policies, which must be passed on and refined through the chemicals supply chain.
All substances are covered by the REACH Regulation unless they are explicitly exempted from its
scope.
Exempt from REACH are: chemical substances that are adequately regulated under other legislation
already in place, e.g. radioactive substances, substances under customs supervision, the transport of
substances and non-isolated intermediates, pharmaceuticals. Waste is also specifically exempted.
A number of other substances are exempted from parts of the provisions of REACH, where other
equivalent legislation applies (for example substances used in medicinal products). Polymers are for
the time being exempted from registration.
RECH Regulation, Article 2 Application
1. This Regulation shall not apply to:
(a) radioactive substances within the scope of Council Directive 96/29/Euratom of 13 May 1996
(b) substances, on their own, in a preparation or in an article, which are subject to customs
supervision, provided that they do not undergo any treatment or processing, and which are
in temporary storage, or in a free zone or free warehouse with a view to re-exportation, or
in transit;
(c) non-isolated intermediates;
(d) the carriage of dangerous substances and dangerous substances in dangerous preparations
by rail, road, inland waterway, sea or air.
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2. Waste as defined in Directive 2006/12/EC of the European Parliament and of the Council2 is not a
substance, preparation or article within the meaning of Article 3 of this Regulation.
3. Member States may allow for exemptions from this Regulation in specific cases for certain
substances, where necessary in the interests of defence.
7. The following shall be exempted from Titles II, V and VI:
(a) substances included in Annex IV, as sufficient information is known about thesesubstances
that they are considered to cause minimum risk because of their intrinsic properties;
(b) substances covered by Annex V, as registration is deemed inappropriate orunnecessary for
these substances and their exemption from these Titles does not prejudice the objectives of
this Regulation;
(c) substances on their own or in preparations, registered in accordance with Title II,exported
from the Community by an actor in the supply chain and re-imported into the Community
by the same or another actor in the same supply chain who shows that:
(i) the substance being re-imported is the same as the exported substance;
(ii) he has been provided with the information in accordance with Articles 31 or 32
relating to the exported substance.
(d) substances, on their own, in preparations or in articles, which have been registered
inaccordance with Title II and which are recovered in the Community if:
(i) the substance that results from the recovery process is the same as the
substance that has been registered in accordance with Title II; and
(ii) the information required by Articles 31 or 32 relating to the substance that
has been registered in accordance with Title II is available to the
establishment undertaking the recovery.
ANNEX IV - The list of exempted substances:

ANNEX V - Exemptions:
1. Substances which result from a chemical reaction that occurs incidental to exposure of another
substance or article to environmental factors such as air, moisture, microbial organisms or sunlight.

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2. Substances which result from a chemical reaction that occurs incidental to storage of another
substance, preparation or article.
3. Substances which result from a chemical reaction occurring upon end use of other substances,
preparations or articles and which are not themselves manufactured, imported or placed on the
market.
4. Substances which are not themselves manufactured, imported or placed on the market and which
result from a chemical reaction that occurs when:
(a) a stabiliser, colorant, flavouring agent, antioxidant, filler, solvent, carrier, surfactant,
plasticiser, corrosion inhibitor, antifoamer or defoamer, dispersant, precipitation
inhibitor,desiccant, binder, emulsifier, de-emulsifier, dewatering agent, agglomerating
agent, adhesion promoter, flow modifier, pH neutraliser, sequesterant, coagulant,
flocculant, fire retardant, lubricant, chelating agent, or quality control reagent functions as
intended; or
(b) a substance solely intended to provide a specific physicochemical characteristic
functions as intended.
5. By-products, unless they are imported or placed on the market themselves.
6. Hydrates of a substance or hydrated ions, formed by association of a substance with water,
provided that the substance has been registered by the manufacturer or importer using this
exemption.
7. The following substances which occur in nature, if they are not chemically modified. Minerals,
ores, ore concentrates, cement clinker, natural gas, liquefied petroleum gas, natural gas condensate,
process gases and components thereof, crude oil, coal, coke.
8. Substances occurring in nature other than those listed under paragraph 7, if they are not
chemically modified, unless they meet the criteria for classification as dangerous according to
Directive 67/548/EEC.
9. Basic elemental substances for which hazards and risks are already well known: hydrogen,
oxygen, noble gases (argon, helium, neon, xenon), nitrogen.
The REACH Regulation was first proposed in 2003, and finally adopted by the Council of Ministers in
December 2006.
The Regulation came into force on 1st June 2007. As a Regulation (rather than Directive),REACH
does not need to be transposed into national legislation, as Regulations become part of Member
State Legislation once they are passed.
System for controlling chemicals in the EU: REACH requires manufacturers and importers to
register and provide safety information within 11 years on approximately 30,000 existing
chemical substances which have been on the market for more than 25 years. Moreover,

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manufacturers and importers acting together with downstream users must analyse and
communicate the use-related risks entailed by their substances.
Former legislation: required the manufacturers and importers of chemicals to provide information
but did not impose similar obligations on downstream users.
Previously there were 40 community Directives and Regulations on chemicals, with separate rules
for new and existing chemicals.
REACH is based on the idea that industry itself is best placed to ensure that the chemicals it
manufactures and puts on the market in the EU do not adversely affect human health or the
environment. This requires that industry has certain knowledge of the properties of its substances
and manages potential risks.
A more detailed comparison of previous legislation and REACH is given in the table below.

2. REACH REGISTRATION
REACH applies to the manufacture, placing on the market or use of substances on their own, in
preparations or in articles and to the placing on the market of preparations.
REACH follows a substance based approach: the obligations do not directly apply to preparations
and articles (with the exemption of the requirements for Safety Data Sheets and exposure scenarios,
which also apply to preparations) but to the substances contained in them.
Industry associations such as CEFIC and UNICE did not accept the above findings and conducted
studies themselves (or urged some governments and EU institutions to do so).
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The industry studies are based on the assumption that the production of many chemicals would stop
because of registration costs.
REGISTRATION REACHs philosophy is that no chemical substance, in whatever form, should
circulate on the market without adequate documentation. To this effect, REACH imposes a
generalised registration requirement: manufacturers or importers of chemicals produced or imported
in volumes of over 1 tonne per year must apply for registration, which is conditioned on the
submission of a technical data file supplying health, safety, and environmental information.
Registration extends previous data reporting requirements19 in a number of significant ways. Most
importantly, registration targets the roughly 30,000 chemicals which have been traded in substantial
volumes within Europe for over 25 years, but for which scant or no information is available.20
Moreover, Registration affects chemicals substances as well as chemicals in preparations21 and in
articles. This means that registration duties not only fall upon chemicals manufacturers and
importers, but also on the vast groups of traders selling goods that contain chemicals, ranging from
cars to disposable lighters.
Registration requires manufacturers and importers of chemicals to obtain relevant information on
their substances and to use that data to manage them safely.
Registration for all substances manufactured or imported in volumes greater than 1 tonne per
annum, the manufacturer or importer must gather information on:

Properties

Identified uses

Safe management.

Manufacturers and importers will submit registration dossiers - information in a standardised format
- demonstrating that chemicals are being managed safely.
Evaluation is undertaken by the Agency for testing proposals made by industry or to check
compliance with the registration requirements.

EVALUATION
The data gathering requirements under REACH connect to the frameworks second risk management
stage: the evaluation procedure. Evaluation covers several processes under REACH.
The first is simply that the Agency will assess a proportion of the substance registration dossiers it
receives to ensure they contain the correct information, known as compliance checking. For
substances registered at 100 tonnes/annum or more, any proposals for further animal toxicity tests
to obtain missing information to complete registration dossiers will be carefully considered by the
Agency, before deciding whether to approve the proposed tests. These proposals will be particularly
closely scrutinised to make sure the tests are absolutely necessary, to keep animal testing to a
minimum. This is known as 'Dossier Evaluation'.

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Finally, there is 'Substance Evaluation' in which a Member State authority will look at all dossiers
for a particular substance for which there may be a considered a need for regulatory action. In order
to ensure a harmonised approach, the Agency shall in cooperation with the Member States develop
risk-based criteria for prioritising substances for these further evaluations.
Dossier evaluation will be conducted by the European Chemicals Agency to decide on proposals for
further testing and assess whether the information supplied in the dossier complies with registration
requirements, and to ensure that unnecessary animal testing is avoided. Evaluation covers the
evaluation of dossiers submitted pursuant to registration, which is compulsory for those containing
proposals for animal testing in order to minimise duplication testing data by more than one
registrant.
Substance evaluations can be performed when there is reason to believe that a substance may
present a risk to human health or the environment, and will look at all the registration dossiers
submitted for the same substance.
Substance evaluation, in turn, is carried out when initial data raise suspicions concerning the health
and/or environmental impact of chemicals. An EU-wide rolling action plan will be established, where
substances targeted for evaluation are allocated to a Member State that acts as rapporteur. Where
suspicions are confirmed, evaluation may trigger further risk management actions, such as the
inclusion of the chemical on the list of substances subject to authorisation, or the drafting of risk
reduction measures.
The Competent Authorities in the Member States will be responsible for performing evaluations.
There are three possible outcomes of the evaluation:

no further action
more information requested
further regulation required

If substances pose unacceptable risks, restrictions on use or a complete ban may be imposed.
Substances with very hazardous properties will be subject to authorisation.

INSTITUTIONAL DESIGN
With the new standards and procedures mapped out in REACH comes a new institutional design to
manage the regulatory framework. Most importantly, the REACH Regulation establishes the
European Chemicals Agency (ECHA), which will function as both the designated supplier of scientific
expertise and opinions to the Commission, and the chief administrator of the scheme.
Whereas formerly Member State national authorities were the first point of contact with private
parties complying with EU regulatory requirements, and thus the chief liaison with Community
authorities, applicants for registration under REACH directly submit their applications to ECHA, which
will: review registration dossiers; check the completeness of the file and, where necessary, request
additional information; perform the registration; and assign a registration number. In the case of
applications for authorisation, applicants submit to ECHA, which then orchestrates the scientific
review of the technical file and risk assessment submitted by the applicant, and drafts a
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recommendation for the Commission. Member State involvement in the process is primarily arranged
through a permanent Member State Committee under ECHAs auspices.
As mentioned before, the Commission takes the lead in decisions relating to substance evaluation
and its outcome, and decides on authorisations, as well as on restrictions on manufacture,
marketing, and use. Member States do however have an opportunity to be closely involved in the
identification of substances for evaluation, and perform the crucial task of substance evaluation.
Additionally, the Member State is represented in Commission decision-making through the familiar
channel of comitology.

3. THE COMMUNICATION REQUIREMENTS OF REACH

Information relating to health, safety and environmental properties, risks and risk
management measures is required to be passed both down and up the supply chain.

Safety data sheet (SDS) - the primary tool for information transfer

Downstream users (DU) are required to consider the safety of their uses of substances,
based primarily on information from their suppliers, and to apply appropriate risk
management measures.

Information provisions - Intensive dialog with the customers and suppliers

REACH demands close communication between producers, importers and users with regard to a
substance's use to ensure that all are aware of any potential risks and possibilities of exposure (for
humans and the environment), as well as the proper measures for protecting humans and the
environment. If produced or imported in quantities of over 10 metric tons per year, a substance's
safety must be carefully analyzed in accordance with Annex I of the REACH legislation. An
assessment of possible exposure and a risk analysis must be performed for all hazardous substances
from this annual quantity upwards.
Therefore we actively seek dialog with our suppliers in order to ensure compliance with REACH
provisions. Exchanging detailed data with our customers and suppliers on uses and exposure is
particularly useful and indeed necessary when we have identified a need for further information
during evaluation of our own substance safety findings.
The passage of information up and down the supply chain is one of the key features of REACH
users should be able to understand what manufacturers and importers know about the dangers
involved in using chemicals, and they can also pass information back up the supply chain.
Downstream users of chemicals (i.e. those who use them at work) will need to comply with any
conditions described in the SDS. Where SDS have attached exposure scenarios that detail how
chemicals may be used, then users should implement the required risk management measures (or
use equivalent measures).

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Safety Data Sheet (SDS) and Extended Safety Data Sheet

As of June 1, 2007, some format changes and content additions apply to SDSs.

The extended safety data sheet (SDS) will be the primary tool for information transfer in the
supply chain.

Extended SDSs under REACH add relevant exposure scenarios based on chemical safety
assessments performed according to registration requirements.

Extended SDSs must include exposure scenarios only when substances are registered.

Extended SDSs will be developed for preparations (products that contain multiple substances)
as well as individual substances.

REACH adopts and builds on an existing system for passing information in a structured way down to
chemicals users the Safety Data Sheet (SDS). This should accompany materials down through
the supply chain, providing the information that users need to ensure chemicals are safely managed.
REACH will also allow for information on uses of chemicals to be passed back up the supply chain, so
that these can be reflected in the SDS.

4. SUBSTANCES WITH PROPERTIES OF VERY HIGH CONCERN

Certain substances that may have serious and often irreversible effects on human health and the
environment can be identified as Substances of Very High Concern (SVHCs). REACH aims at ensuring
that the risks resulting from the use of SVHCs are controlled and that the substances be replaced
where possible.
A Member State, or ECHA on request of the European Commission, can propose a substance to be
identified as an SVHC.
For substances of very high concern, use-specific permission from the Commission will be required.
The manufacturer or importer must show that risks can be controlled. Substances of very high
concern

are

PBTs

(persistent,

bio-accumulative

and

toxic)

vPvBs

(very

persistent,

very

bioaccumulative) and CMRs (carcinogenic, mutagenic or toxic to reproduction) and endocrine

disrupting chemicals.
Substances with properties of very high concern will be made subject to authorisation; the
Agency will publish a list containing such candidate substances. Applicants will have to demonstrate
that risks associated with uses of these substances are adequately controlled or that the socioeconomic benefits of their use outweigh the risks. Applicants must also analyse whether there are
safer suitable alternative substances or technologies. If there are, they must prepare substitution
plans, if not, they should provide information on research and development activities, if appropriate.

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The Candidate List

(Candidate List of Substances of Very High Concern for Authorisation)
The first step in the authorisation process is to identify those substances that may have serious
effects on human health or the environment and, therefore, the risks resulting from their use must
be properly controlled and the substances progressively replaced when possible.
A Member State or ECHA at the request of the European Commission, can propose a substance to be
identified as a Substance of Very High Concern (SVHC). If identified, the substance is added to the
Candidate List, which includes candidate substances for possible inclusion in the Authorisation List
(Annex XIV).
The inclusion of a substance in the Candidate List creates legal obligations to companies
manufacturing, importing or using such substances, whether on their own, in preparations or in
articles.
The intention to propose a substance to be identified as an SVHC is made public in the registry of
intentions before the proposal is submitted so as to give advanced information to industry and other
stakeholders.
The Agency publishes and regularly updates a list of substances (list of candidate substances)
identified as having characteristics of extremely high concern. These may include the following:

CMRs (carcinogens, mutagens and reproductive toxins);

PBTs (persistent, bioaccumulative and toxic substances);
vPvBs (very persistent and very bioaccumulative substances);
some substances of concern which have irreversible serious effects on humans and the
environment, such as endocrine disruptors.

5. AUTHORISATION
The most controversial pillar of REACH is the authorisation requirement for highly dangerous
chemicals, such as CMRs, PTBs and vPvBs.
Authorization ensures that the risks associated with the use of substances of very high concern
(SVHC) are properly controlled and that these substances are progressively substituted with safer
alternatives.
Substances

requiring

authorization include those

meeting the

criteria for classification as

carcinogenic, mutagenic, or reprotoxic (CMR) categories 1 and 2; substances that are persistent,
bioaccumulative, and toxic (PBT); and substances that are very persistent and very bioaccumulative
(vPvB).
Substances for which scientific evidence of probable serious effects on humans or the environment
exists, which gives rise to equivalent concern as the aforementioned categories (e.g., endocrine
disruptors), can be identified on a case-by-case basis.
The Authorisation system will require companies to switch progressively to safer alternatives where a
suitable alternative exists. Current use restrictions will remain under REACH system.

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After the lapse of a sunset date, those chemicals that have been identified as subject to an
authorisation requirement can only be produced, traded and/or used if Commission approval has
been obtained. It is incumbent on the private applicant for authorisation to furnish proof, in the form
of an extensive data file including a risk assessment and risk management recommendations, that
the risks posed by the chemical are either adequately contained, or that no usable alternatives
currently exist but substitutes are being investigated.
Applications are reviewed by the European Chemicals Agency (ECHA), which produces an opinion for
the Commission. According to the wording of the REACH Regulation, if the risks are shown to be
adequately contained, the Commission must authorise. If, on the other hand, it is impossible fully to
contain the risks, the Commission may grant authorisation, depending on the severity of the risk and
viability of alternatives. Authorisations are subject to review and monitoring.
Policy measures to phase out chemicals that pose unreasonable and unmanageable risk to human
health and human environment, such as, for example, ozone-depleting substances EU REACH
Regulation contains several provisions that will assure that the risks from substances of very high
concern are properly controlled and that these substances are progressively replaced by suitable
alternative substances or technologies where these are economically and technically viable
(authorisation procedure).
Authorization includes identification of substances that are banned for general use.
It also includes authorization of specific uses of such substances banned for general use 1) under
defined risk management regimes or 2) based on socio-economic justification.
Authorization requests should include an analysis of alternatives, a substitution plan when a
suitable alternative is available and information about any relevant research and development
activities for the application
Authorization must be renewed periodically as specified in the authorization decision.

6. MANUFACTURE, MARKETING AND USE RESTRICTIONS

This is a direct and unambiguous means of controlling the risks associated with any given hazardous
substance. A substance on its own, in a preparation or in an article, which has been restricted shall
not be manufactured, placed on the market or used unless it complies with the conditions of that
restriction. Restriction will be used when it is felt that action at the European level is needed.
Restriction decisions will also be made by the Agency, consulting with EU Member States and others.
Restrictions in place already from previous legislation are carried over into REACH in Annex XVII;
further restrictions will be added to this Annex.
If a chemical poses an unacceptable risk that needs to be addressed on a EU-wide basis, a Member
State or ECHA (on request of the Commission) may propose a restriction on the manufacturing,
placing on the market or the use of that chemical of concern.
Restrictions limit or ban the manufacture, placing on the market or use of certain substances that
pose an unacceptable risk to human health and the environment. A Member State, or ECHA on
request of the European Commission, can propose restrictions.
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Anyone can comment on a proposal to restrict a substance. Those most likely to be interested are
companies, organisations representing industry or civil society, individual citizens, as well as public
authorities. The public consultation lasts for six months.
The Risk Assessment Committee (RAC) evaluates whether the suggested restriction is the
appropriate measure to reduce the risk to human health and the environment. Within nine months of
the publication of the proposal, RAC will adopt its opinion.
ECHA forwards the two opinions of the scientific committees to the European Commission. The
Commission will draft an amendment to the list of restrictions (Annex XVII of REACH) within three
months. A new restriction or a revision of an existing restriction will be adopted if the European
Council of Ministers or the European Parliament do not oppose to the restriction.
List of Restrictions

The list of restrictions contains those substances (on its own, in a mixture or in an article) for which
manufacture, placing on the market or use is limited or banned in the European Union.
This list is Annex XVII to REACH and includes all the restrictions adopted in the framework of REACH
and the previous legislation, Directive 76/769/EEC. Each entry shows the substance or group of
substances or the mixture, and the conditions of their restriction.
The latest consolidated version of REACH presents the restrictions adopted until that date.
Subsequent changes are included in the amending Commission regulations.

7. ENFORCEMENT
REACH firmly embraces a policy of no data, no market. After the transition dates have passed, any
unregistered chemical (or chemical use) should be taken out of circulation. For old or existing
chemicals, this daunting penalty for nonregistration is precisely what distinguishes registration from
preceding data reporting duties under the Existing Substances Regulation, the failure of which to
deliver results was broadly attributed to the absence of a credible threat in case of noncompliance.33 Hence, the credibility of REACH as a workable system for risk control, both within the
EU and on the global scene, will hinge largely on the effectiveness with which regulatory provisions
are enforced. This is where the role of the Member State is crucial, as enforcement of the REACH
requirements is entirely a national responsibility.

8. CONCLUSIONS AND OUTLOOK

The impact of REACH will not be limited to the EUs borders, nor will its benefits.
While engaging in the REACH debate, many companies and EU international partners focused on
reducing the economic impacts of the regulation on companies. For example, some lobbying focused
on lowering the information requirements for registration or exemptions for registration in annexes
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IV or V, while others focused on limiting the impact of the substitution principle enshrined in
authorization. Yet little was said on the foreseen benefits of REACH for humans and the environment.
The outlook for REACH is at present still unclear in terms of the capacity of industry and government
authorities to meet expectations.
Over the years, the EU has accumulated considerable experience in this regard, which points to the
necessity of a broad-based approach, taking into account information from a variety of sources in a
weight-of-evidence approach and using expert judgment.
A new challenge ahead for the implementation of REACH is its application to nanomaterials.
Questions arise in relation to substance identification and tonnage thresholds, which may prevent
REACH from generating in all cases the comprehensive information it is expected to produce. The
REACH approach of using tonnage as a proxy for exposure and hence for risk may need careful
examination when applied to nanomaterials.
Knowledge knows no borders; neither does pollution. The EU has taken a first step toward a safer
management of chemicals, and, although much work still remains, we should welcome the changes
that REACH will bring globally.

Zvonimir Bakari
zvonimir.bakaric@petrokemija.hr
Petrokemija Plc., Croatia
09. September 2015

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