EUROPEAN
COMMISSION

Brussels, 5.2.2013
SWD(2013) 25 final

COMMISSION STAFF WORKING DOCUMENT
General Report on REACH
Accompanying the document
REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE
COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE
COMMITTEE OF THE REGIONS
in accordance with Article 117(4) REACH and Article 46(2) CLP, and a review ofcertain elements of REACH in line with Articles 75(2), 138(3) and 138(6) of REACH{COM(2013) 49 final}EN

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TABLE OF CONTENTSPART I . OPERATION OF REACH................................................................................. 3
1.

GENERAL ISSUES.................................................................................................... 3
1.1. Scope and application ....................................................................................... 3
1.2. Definitions....................................................................................................... 17

2.

REGISTRATION ..................................................................................................... 23

3.

DATA SHARING AND AVOIDANCE OF UNNECESSARY TESTING ............ 33
3.1. Data sharing .................................................................................................... 33
3.2. Avoidance of unnecessary testing................................................................... 37

4.

INFORMATION IN THE SUPPLY CHAIN ........................................................... 46

5.

DOWNSTREAM USERS ........................................................................................ 54

6.

EVALUATION......................................................................................................... 60

7.

AUTHORISATION.................................................................................................. 67

8.

RESTRICTIONS ...................................................................................................... 76

9.

ECHA........................................................................................................................ 82
9.1. Process, internal structure and operations....................................................... 82
9.2. Committees ..................................................................................................... 88
9.3. Fees and charges ............................................................................................. 93

10. COMPETENT AUTHORITIES ............................................................................... 97
11. ENFORCEMENT ................................................................................................... 103
12. INFORMATION..................................................................................................... 111
PART II . ACHIEVING REACH OBJECTIVES ......................................................... 116
1.

HUMAN HEALTH AND ENVIRONMENT ........................................................ 116
1.1. Background and Introduction ....................................................................... 116
1.2. Registration ................................................................................................... 118
1.3. Requirements concerning information in the supply chain .......................... 120
1.4. Authorisation and restrictions ....................................................................... 122
1.5. Conclusions................................................................................................... 124

2.

SINGLE MARKET, COMPETITIVENESS AND INNOVATION ...................... 127
2.1. Background ................................................................................................... 127
2.2. Single market ................................................................................................ 128
2.3. Competitiveness ............................................................................................ 131
2.4. Innovation ..................................................................................................... 138
2.5. Perspective of SMEs ..................................................................................... 144
2.6. Summary and conclusions ............................................................................ 145

PART III . CLP ENFORCEMENT ACTIVITIES ........................................................ 148

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Part I.
OPERATION OF REACH
1.

GENERAL ISSUES

1.1.

Scope and application

Article 1(1) of REACH sets out that the aim of the Regulation is to ensure a high levelof protection of human health and the environment, including the promotion ofalternative methods for assessment of hazards of substances, as well as the freecirculation of substances on the internal market while enhancing competitiveness andinnovation. The legal basis for REACH is Article 114 TFEU (Article 95 of the former
EC Treaty) relating to the establishment and the functioning of the internal market.
As set out in Article 1(2), REACH applies to substances and mixtures. This Article
states further that REACH provisions apply to “the manufacture, placing on themarket or use of such substances on their own, in mixtures or in articles and to theplacing on the market of mixtures.”
Article 138(6) sets out that: “By 1 June 2012 the Commission shall carry out a review
to assess whether or not to amend the scope of this Regulation to avoid overlaps withother relevant Community provisions.” Article 138(6) further states that “On the basisof that review, the Commission may, if appropriate, present a legislative proposal.”During this review, in the analysis of the scope, the Commission services focused onpractical issues where potential overlaps with other relevant EU legislation may
appear. In fulfilling this task, different pieces of EU legislation were considered that
may be related to REACH provisions. A number of REACH provisions affect thescope of REACH and its Titles, in particular Articles 2, 14, 15, 56, 58, 60, 61, 62 and
67. Annexes I, II, XIV and XVII are also important in the context of discussions on
scope especially as they have points of contact with other pieces of legislation.
Overlaps, generally, were understood as situations where two pieces of EU legislation
regulate the same situation which may lead to instances of legal uncertainty or wherelegal requirements lead to unnecessary burdens on dutyholders (e.g. imposing thesame or similar regulatory requirements twice or imposing conflicting requirementson the same actors pursuant to two different pieces of legislation). The purpose of
Article 138(6) should thus be understood as aiming at avoiding these negative
overlaps and ensuring more efficient interactions between pieces of legislation at the
EU level.
Incidentally, comparing the scope of other pieces of EU legislation with the REACH
scope also permits to identify certain synergies that can serve as inspiration for further
work of the Commission and stakeholders.

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Part I.
Operation of REACH

General Issues

For the purpose of this review, 155 EU legal acts regulating chemicals, products,
environmental protection, workers’ protection and food safety have been analysed1.
The instances of overlaps or potential overlaps between REACH and other EU
legislation identified in the review pertain to REACH registration, information in the
supply chain, authorisation or restrictions. Two instances of regulatory gaps identified
by the review are also outlined in this section. Some examples of pieces of EU
legislation concerned by synergies are listed at the end of this Title.
Potential overlaps or overlaps with registration and information in the supply
chain– Safeners and synergists of plant protection products: a potential overlap regarding
safeners and synergists of plant protection products was identified, which – likeactive substances - are subject to Commission approval under the new Plant
Protection Products Regulation (PPPR)2 and for which a review programme will beestablished by 14 December 2014, but which are not regarded as registered for the
purposes of REACH, as they are not mentioned in Article 15(1) REACH. Similar
data requirements as those related to active substances should be defined forsafeners and synergists in the PPPR implementing legislation. Since the requisite
implementing legislation under the PPPR has not yet been adopted, the degree ofpotential overlap is difficult to assess at this moment in time.
– Co-formulants in biocidal products: a potential overlap regarding co-formulants inbiocidal products was identified. Article 15(2) only regards active substances
included in the Annexes of the Biocidal Products Directive (BPD)3 as being
registered but not their co-formulants. As a consequence, these have to beregistered under REACH. Annex VI of the BPD requires a risk assessment,
equivalent the one carried out for active substances, for co-formulants which aresubstances of concern present in the biocidal product. Therefore the assessment of
co-formulants which are substances of concern under both REACH and the BPD
may result in a potential overlap. Duty-holders may have to perform a similar risk
assessment twice. It must be noted that the BPD has just been replaced by a newRegulation4. Similarly to the BPD, Annex VI point 5 of the Biocidal Products
Regulation requires a risk assessment for substances of concern. However, therelevant provision sets out that information submitted in the framework of REACH

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1

Study “Technical assistance related to the scope of REACH and other relevant EU legislation toassess overlaps” , Milieu, commissioned by European Commission, March 2012.

2

Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009
concerning the placing of plant protection products on the market and repealing Council Directives
79/117/EEC and 91/414/EEC, OJ L 309, 24.11.2009, p. 1.

3

Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning
the placing of biocidal products on the market, OJ L 123, 24.4.1998, p. 1.

4

Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012
concerning the making available on the market and use of biocidal products, OJ L 167, 27.6.2012,
p.1.

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Part I.
Operation of REACH

General Issues

should be taken into account where appropriate. The potential overlap concerning
co-formulants thus appears to be sufficiently addressed in the BPR.
– Pyrotechnic articles: The Commission services concluded that certain pyrotechnic
articles, considered as mixtures under REACH, might be subject to a double
regulatory burden, at least as far as communication of the information in the supply
chain is concerned. In such a case both obligations under REACH and under the
Pyrotechnic Articles Directive5 would apply at the same time. According to thecurrent ECHA guidance on requirements for substances in articles, a majority ofpyrotechnic articles should be regarded as packaged mixtures, whereas they are
regarded as articles by the technical experts in the responsible CEN TechnicalCommittee (TC 212) and also by some competent authorities of the Member
States. The Commission services will investigate whether this issue requires
specific action, including, in particular in the Guidance on requirements for
substances in articles.
– Medical devices6: Article 2(6)(c) of REACH exempts medical devices which are
mixtures, in the finished state and intended for the final user and which areinvasive or used in direct physical contact with the human body, from theprovisions of Title IV (Information in the Supply Chain), as long as the same levelof information provision and protection is ensured for any substances or mixturesclassified as dangerous as under Directive 1999/45/EC7. The Commission services
take the view that the Directives governing medical devices provide such a level of
information provision and protection. The exemption however does not apply to
medical devices in the form of articles (such as active implantable medical devices
governed by Directive 90/385/EEC), nor does it apply to in vitro medical
diagnostics governed by Directive 98/79/EC (as these are not used in direct contact
with the human body), even though the latter Directive expressly provides forlabelling in line with Directives 67/548/EEC8 and 1999/45/EC. The scope of the
exemption therefore appears very limited. Such articles or mixtures, not being
subject to the exemption, would thus be potentially subject to an overlap in termsof information requirement.

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5

Directive 2007/23/EC of the European Parliament and of the Council of 23 May 2007 on theplacing on the market of pyrotechnic articles, OJ L 154, 14.6.2007, p. 1.

6

Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member
States relating to active implantable medical devices, OJ L 189, 20.7.1990, p. 17; Council
Directive 93/42/EEC of 14 June 1993 concerning medical devices, OJ L 169, 12.7.1993, p. 1;
Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro
diagnostic medical devices, OJ L 331, 7.12.1998, p. 1.

7

Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning
the approximation of the laws, regulations and administrative provisions of the Member States
relating to the classification, packaging and labelling of dangerous preparations, OJ L 200,
30.7.1999, p. 1.

8Council Directive 67/548/EEC of 27 June 1967 on the approximation of the laws, regulations andadministrative provisions relating to the classification, packaging and labelling of dangerous
substances, OJ 196, 16.8.1967, p. 1.

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Part I.
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General Issues

Furthermore, the use of a substance in a medical device, and its risks to the safetyof patients and medical professionals, is assessed within the context of the
Directives on medical devices and the subsequent harmonised standards. Articles
60(2) and 62(6) of REACH recognise this prior assessment in exempting SVHCs
used in medical devices from the human health risk assessment in the authorisation
process. However, during the REACH registration process, substances used in
medical devices are subject to chemical safety assessment for all intended uses.
This constitutes a potential overlap as a risk assessment would have to be
performed both under REACH and the medical devices legislation.
Under the REACH risk assessment, safe use has to be demonstrated through an
exposure assessment, whilst in the Directives on medical devices an exposure
assessment is performed and the identified risks then weighed against the benefits.
There is thus in addition a potential contradiction in that a substance used in a
medical device may not be considered as controlled under Article 14(6) of REACH
and Annex I but the risks of the use of the substance may still be accepted underthe medical devices legislation.
An overlap was identified for those “Class III” medical devices incorporating, as
an integral part, a substance which, if used separately, can be considered to be a
medicinal product and which is liable to act on the human body with action
ancillary to that of the devices. Such Class III medical devices are assessed andauthorised in accordance with Directive 93/42/EEC9, but the quality, safety andusefulness of the substance must be verified by analogy with the methods specified
in Annex I to Directive 2001/83/EC10, which covers human health risks andrequires an environmental risk assessment where applicable. The substances
concerned do not benefit from the exemption of Article 2(5)(a) of REACH, as
Article 1(5)(c) of Directive 93/42/EEC excludes medicinal products covered by
Directive 2001/83/EC11 from its scope, although the assessment they undergo iscomparable to that under Directive 2001/83/EC. There is a potential overlap in thatthe substances used in these medical devices will be subject to REACH Titles II,
V, VI and VII provisions as well as an assessment equivalent to the one set out inthe medicinal products directive.
– Workplace legislation: There is certain level of confusion between derived noeffect levels (DNELs) under REACH and various occupational exposure limits(OELs) developed under other EU legislation (Chemical Agents Directive12 or
Carcinogens and Mutagens Directive13) or national workers protection legislation

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9

Article 1(4) of Directive 93/42/EEC.

10

Annex I, section 7.4 of Directive 93/42/EEC.

11

Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on theCommunity code relating to medicinal products for human use, OJ L 311, 28.11.2001, p. 67.

12

Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers
from the risks related to chemical agents at work (fourteenth individual Directive within themeaning of Article 16(1) of Directive 89/391/EEC), OJ L 131, 5.5.1998, p. 11.

13

Directive 2004/37/EC of the European Parliament and of the Council of 29 April 2004 on theprotection of workers from the risks related to exposure to carcinogens or mutagens at work (Sixth

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ENPart I.
Operation of REACH

General Issues

and how these two potentially different values should be reflected down the supply
chain in the SDS to be used by the employer. Because two sets of values have to be
derived under the pieces of legislation, there is a potential overlap.
As far as registrant's chemical safety assessment is concerned, guidance onderiving DNELs in cases when the EU or the national OEL are available isprovided in the ECHA Guidance on information requirements and the chemicalsafety assessment (Chapter R 8).
The Commission services are of the view that OELs and DNELs (for both the same
duration and the same route of exposure) may co-exist, and in some circumstances
may apply simultaneously to some work activities. In certain cases, where theguidance allows the registrant to use OEL instead of deriving DNEL, the problemof two different values would not arise. In other cases, it is the Commission's view
that, in principle, the lowest level should be complied with by the employer. The
binding OEL needs to be always complied with by the relevant employer. In cases
when the DNEL is lower than the OEL, the compliance with DNEL is based on thepremise that the registrant could not use OEL instead of deriving DNEL for thesame exposure route and duration, as he has obtained new scientific information
which indicated that the OEL does not provide the appropriate level of protection.
Annex II to REACH provides for an obligation to list the relevant applicable EU or
national OELs in Section 8 of the SDS (exposure controls/personal protection.
Therefore the Commission services consider that more guidance on the relationshipbetween the DNEL and different OELs in the ECHA Guidance on the compilationof SDS would be helpful for dutyholders to fulfil properly their obligation tocompile a SDS to avoid confusion between the two systems. The SDS itself could
contain some explanation how those two values should be considered by thedownstream user as an employer.
– The harmonised classification under the CLP Regulation14: Although it has beenreported to the Commission that the process of harmonised classification under
Title V of the CLP Regulation and the REACH process of identification ofsubstances for the candidate list under Article 59 constitutes an overlap with regard
to substances classified as carcinogenic, mutagenic or toxic for reproduction(CMR) under CLP, the Commission services do not concur with that view. The
objectives of those two procedures are different, same as the legal implications.
The harmonised classification and labelling of the substance under CLP is adifferent risk management measure comparing to the REACH authorisation.
Whereas one of the objectives of CLP is to establish a list of substances with theirharmonised classifications and labelling elements at EU level, the candidate list is
the first step in the authorisation process under REACH. The purpose ofindividual Directive within the meaning of Article 16(1) of Council Directive 89/391/EEC), OJ L
158, 30.4.2004, p. 50.
14ENRegulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December
2008 on classification, labelling and packaging of substances and mixtures, amending andrepealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006,
OJ L 353, 31.12.2008, p. 1

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Part I.
Operation of REACH

General Issues

establishing a candidate list is, according to Article 59, the eventual inclusion ofsubstances in Annex XIV, i.e. identifying substances to be subjected to theauthorisation requirement. This is why before considering the inclusion of a
substance in the candidate list, an assessment of the best risk management option
under REACH is performed (see [Title 7]) and no automatic link is assumed
between the classification of a substance as a CMR and its inclusion in thecandidate list. There is also a substantial difference in the procedure. Under Article
37 CLP, it is the RAC, composed of members with scientific and technicalexpertise, assessing in-depth (within 18 months of receipt of the proposal) the
proposal for harmonised classification and labelling of a substance. In the processof identification of substances for the candidate list under Article 59 REACH, theCommittee that may become involved is the MSC, whose composition and rolediffers from RAC. The assessment under this process is expected to be lighter,under shorter deadlines, and the work already done under the CLP Regulation isalready taken into account, as the Annex XV dossier may be limited, if appropriate,
to a reference to an entry in Part 3 of Annex VI of the CLP.
– End-of-waste criteria versus recovered substances: Concerns have been reported to
the Commission regarding the potential overlap stemming from the fact thatrecovered substances are subject to REACH registration, unless covered by an
exemption. Pursuant to Article 6 of the Waste Framework Directive15, in order fora certain specified waste to cease to be waste, it has to fulfil the end-of-waste
criteria developed either at EU level or at Member State level. Some perceive apotential overlap in risk assessment in that the derivation of end-of-waste criteria
already assesses human health and environmental impact of the material (riskassessment carried out as part of the REACH registration for a recovered substancewould amount to an overlap, as the same material would have already been subject
to a risk assessment at the waste stage.) The Commission services, however, would
like to stress that the assessment for the end-of-waste criteria under Article 6 of the
Waste Framework Directive is of a different nature as it is carried out by theMember States authorities and it encompasses different elements. The environmentand health impact assessment of the material is considered in determining end-ofwaste criteria to the extent whether the material in question merits application of
the waste legislation. It is assumed that risks from the product of the recovery will
be covered by another appropriate legislation. The Commission services would
thus conclude that this does not amount to an overlap and does not jeopardise thepolicy objectives of the two legislations.
– Cosmetics and animal testing: The fact that Article 18 of the Cosmetics
Regulation16 bans animal testing for finished products and ingredients or
combination of ingredients and bans placing on the market of cosmetic products
containing ingredients or combinations of ingredients tested on animals has been

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15

Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008 on
waste and repealing certain Directives, OJ L 312, 22.11.2008, p. 3.

16

Regulation No. 1223/2009 of the European Parliament and of the Council of 30 November 2009
on cosmetic products, OJ L 342, 22.12.2009, p. 59.

8ENPart I.
Operation of REACH

General Issues

reported to the Commission as an issue of a potential overlap with REACH. Article2(4)(b) REACH sets out that REACH applies without prejudice to the cosmetics
legislation as regards testing involving vertebrate animals within the scope of thatlegislation. The Commission services continue reflecting on how this issue should
be best addressed. It is important to note, in this respect, that REACH envisages
the vertebrate animal testing only as a last resort.
Overlaps in restrictions
A number of pieces of EU sector specific legislation provide for restrictions of certain
substances or groups or categories of substances. It has been reported that it would be
useful to have a publicly available database that would serve as an inventory of all
restrictions laid down in EU legislation for particular individual substances. The
Commission services do not consider, in general, as an overlap the situation where thesame substance is restricted by different pieces of EU legislation provided different
uses are restricted by different pieces of legislation. However, the overlap may arise
when the same use is restricted in two different pieces of legislation.
Some double restrictions of the same use have been identified which are not entirely
consistent.
– PCB/PCT Directive17: The PCB/PCT Directive does not provide restrictions, butrather complements REACH restrictions with the rules on the disposal anddecontamination of polychlorinated biphenyls and polychlorinated terphenyls. One
minor overlap has been identified. The PCB/PCT Directive by allowing a use of
PCBs in transformer equipment if the mixture does not contain more than
0.005%18 seems to be in contravention to the absolute restriction of the use of
substances or in mixtures of entries 24, 25 and 26 in Annex XVII to REACH
which do not provide such a threshold.
It has been also reported that there may be an inconsistency with respect to the
PCB/PCT Directive allowing transformers in which the fluids contain less than
0.05% PCBs to remain in use19, and the restrictions for the use of entries 1, 24, 25
and 26 of Annex XVII. The Commission services are of the view that this is not an
inconsistency, as most of the transformers would be considered as articles under
REACH and therefore not subject to the restriction of use as a substance or in
mixtures in those entries.
– Toys Safety Directive20: The Toys Safety Directive makes it clear in recital (21)and in Annex III that REACH restrictions, when they exist for the use in toys, alsoEN

17

Council Directive 96/59/EC of 16 September 1996 on the disposal of polychlorinated biphenyls
and polychlorinated terphenyls (PCB/PCT), OJ L 243, 24.9.1996, p. 31.

18

Article 2a of the Directive

19

Articles 3 and 9 of the Directive

20

Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safetyof toys, OJ L 170, 30.6.2009, p. 1.

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Part I.
Operation of REACH

General Issues

apply. However, the Commission services recognise the difficulty for stakeholders
to get a clear picture of the regulatory framework and the need to better
communicate on it to ensure compliance. The following REACH restrictions are
specifically addressed to toys:• Entries 51 and 52 of Annex XVII to REACH prohibit the use of several
phthalates in toys in concentrations greater than 0.1% by weight of theplasticised material, and prohibit the placing on the market of toys containing
these phthalates. The Toys Safety Directive does not address phthalates intoys specifically; however, some of the phthalates concerned are classified as
toxic to reproduction category 1B and CMRs, in general, cannot be used intoys, components of toys or parts of toys, subject to derogations (Annex II
section III to the Toys Safety Directive). The two instruments thus set out aban with different conditions of applications. The differences in criteria andapplicable limits may lead to uncertainty for operators concerned as to their
obligations. The Commission services are of the view that the more stringent
restriction applies.
• Entry 43 of Annex XVII to REACH prohibits the use of azodyes in, inter alia,
textile or leather toys which may come into direct and prolonged contact withthe human body, if these azodyes may release certain aromatic amines above
30 mg/kg (0.003% by weight) in the articles or their dyed parts. The placing
on the market of non-conforming toys is prohibited. The Toys Safety
Directive does not address azodyes. Operators must therefore be aware of
relevant restrictions in REACH.
• Entry 5 of Annex XVII to REACH prohibits the use of benzene in toys orparts of toys where its concentration in the free state is greater than 5 mg/kg(0.0005%) of the weight of the toy or part of toy. The placing on the market
of non-compliant toys is prohibited. The Toys Safety Directive governs
benzene as well: since benzene is classified as a carcinogen category 1A, it
cannot be used in toys, components of toys or parts of toys, subject toderogations (Annex II section III to the Toys Safety Directive). The two
instruments thus set out a ban with different conditions of applications. The
differences in criteria and applicable limits may lead to uncertainty for
operators concerned as to their obligations. The Commission services are of
the view that the more stringent restriction applies.
The following general REACH restrictions are also relevant for toys:• Entry 27 of Annex XVII to REACH prohibits the use of nickel in articles(including toys) intended to come into direct and prolonged contact with theskin, if the rate of nickel release from the parts coming into such contact isgreater than 0.5 μg/cm²/week. The placing on the market of non-compliant
articles is prohibited. The Toys Safety Directive governs nickel as well: sincenickel is classified as a carcinogen category 2, it cannot be used in toys,
components of toys or parts of toys, subject to derogations (Annex II section
III to the Toys Safety Directive); at the same time, and without prejudice tothe ban and derogations, specified nickel migration limits from toys orcomponents of toys cannot be exceeded. The differences in criteria and

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Part I.
Operation of REACH

General Issues

applicable limits may lead to uncertainty for operators concerned as to their
obligations.
• Entry 23 of Annex XVII to REACH prohibits the use of cadmium in articles(including toys) produced from plastic material and prohibits the placing on
the market of such articles if the concentration of cadmium is equal to or
greater than 0.01% by weight of the plastic material. Painted articles(including toys) cannot be placed on the market if the concentration of
cadmium is equal to or greater than 0.1% by weight of the paint on the painted
article. The Toys Safety Directive governs cadmium as well: specified
cadmium migration limits from toys or components of toys cannot be
exceeded. The differences in criteria and applicable limits (especiallyconcentration limits versus migration limits) may lead to uncertainty for
operators concerned as to their obligations.
• RoHS Directive21: Entry 23 of Annex XVII to REACH prohibits the use of
cadmium in cadmium plating metallic articles or components for a certain
number of applications but permits it for electrical contacts in any sector ofuse, where that is necessary to ensure the reliability required of the apparatus
on which they are installed. The RoHS Directive prohibits the placing on themarket of electrical and electronic equipment that contain more than 0.01% of
cadmium by weight in homogenous materials. However, Annex III of RoHS
provides for an exemption from this restriction when cadmium and its
compounds is used in electrical contacts. This exemption from restriction isthus broader than REACH as it does not set out a condition of reliability of
the apparatus on which these electrical contacts are installed in order to be
triggered. The differences in the conditions of application of the two
exemptions may lead to uncertainty for operators concerned as to their
obligations.
Potential overlaps related to future restrictions:
In the context of consideration of preparations of future restrictions under REACH,
the Guidance on the preparation of Annex XV dossiers states that a restriction under
REACH may be an appropriate measure in cases where the proper implementationand enforcement of risk management measures under other REACH processes(notably registration) or under other legislation is not possible to achieve22. Other risk
management options (RMOs) using other sector specific EU legislation should be
explored in order to address the identified unacceptable risk in the most appropriate
way. It is important to note that if a Member State or ECHA identifies, in the context
of the preparation of the Annex XV dossier, that a measure under other EU legislation
is more appropriate way of addressing the risk than a REACH restriction, this should
be documented in the Annex XV dossier. In some cases, action under other EU

EN

21

Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the
restriction of the use of certain hazardous substances in electrical and electronic equipment, OJ L
174, 1.7.2011, p. 88.

22

See Guidance on Annex XV for restrictions, p. 15.

11ENPart I.
Operation of REACH

General Issues

legislation may be considered as a necessary complementary measure to a proposed
REACH restriction. These findings could then be used by the competent authorities
and the Commission to determine if action under other EU legislation is appropriate.
The Commission services recognize that it is important to avoid any possible future
overlaps or inconsistencies with restrictions laid down in EU sector specificlegislation.
Potential overlaps with REACH authorisation
The Commission services recognise that there is risk of potential overlap once thesubstance is included in the REACH authorisation list (Annex XIV) and theexemptions for specific uses from the restrictions in different pieces of EU legislation,such as the RoHS Directive23, the End of Life Vehicles Directive24 and the Packaging
Directive25. For uses of a substance which is restricted under sectoral legislation andat the same time subject to REACH authorisation, there is a concern that operators
would need to go through two separate and independent procedures in order to be able
to continue to use the substance, i.e. one under REACH authorisation, and the otherfor the exemption to apply under the sectoral legislation. Even if the operator alreadysuccessfully applied to the Commission for a time-limited exemption for a use under
the relevant sectoral legislation, there is no guarantee that the authorisation under
REACH would be eventually granted by the Commission for the same use. The
provisions in Article 58(2) of REACH allow to exempt uses or categories of usesfrom authorisation provided that there is specific EU legislation imposing minimum
requirements relating to the protection of human health or the environment that
ensures proper control of the risks. There is only a limited experience with the use of
the Article 58(2) exemption. Three of the current 14 substances in Annex XIV have
exemptions from uses based on this provision and in relation to the EU medicinal
products legislation. It nonetheless needs to be reviewed how these criteria are
currently applied and to what extent they can be used for the exemption of uses
covered by exemptions in specific sectoral legislation.
Moreover, the Commission would need to consider how to best use Article 58(2) inorder to avoid potential overlaps in other cases, e.g. where the EU workplacelegislation sets a binding OEL that applies to a specific use.
The Commission services will explore on a case by case to what extent the Article
58(2) exemption from authorisation may be used in order to exempt from theauthorisation requirement the uses that have been already specifically considered in
the context of another EU legislation. More generally, the Commission already
explores in the risk management options procedure whether it is appropriate to target

EN

23

Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the
restriction of the use of certain hazardous substances in electrical and electronic equipment, OJ L
174, 1.7.2011, p. 88.

24

Directive 2000/53/EC of the European Parliament and of the Council of 18 September 2000 on
end-of life vehicles, OJ L 269, 21.10.2000, p. 34.

25

European Parliament and Council Directive 94/62/EC of 20 December 1994 on packaging andpackaging waste, OJ L 365, 31.12.1994, p. 10.

12ENPart I.
Operation of REACH

General Issues

by Annex XIV substances that are already restricted in many other pieces of EU
legislation.
Potential gaps
Potential gaps were also identified in the process of the review. They are outlined
below.
– Animal testing: A potential gap was identified regarding the Animal Testing
Directive26. This Directive defines live non-human vertebrate animals falling under
its scope as including earlier forms of development such as ‘independently feedinglarval forms’ and ‘foetal forms of mammals as from the last third of their normal
development’. Data sharing is obligatory under REACH for data generated fromthe testing of vertebrate animals, but REACH does not specify that vertebrate
animals include larval and foetal forms. It is therefore unclear whether earlier
forms of development of vertebrate animals are provided the same level ofprotection under REACH as under the Animal Testing Directive. The Commission
services would recommend construing the term ‘vertebrate animal’ under REACH
in the light of Directive 2010/63/EU so as to include larval and foetal forms.
– Use of cephalopods in animal testing: Another potential gap was identified in that
the Animal Testing Directive, unlike REACH, covers live cephalopods. Data–sharing
would not be compulsory under REACH if the data is generated through test on nonvertebrate animals which includes cephalopods. The Commission services will investigate
the possibility to subject cephalopods to the same regime as vertebrates.

Synergies in the use of data:
Potential synergies have been identified that relate to information requirements
imposed in the context of REACH and those stemming from regulatory requirementsfrom sector specific legislation. Data collected by dutyholders pursuant to one pieceof EU legislation could be useful in the context of REACH and vice-versa. Some
examples are listed below in bullet points, this list being not exhaustive:– Quality of Petrol Directive27: metallic fuel additives are, in principle, substances
subject to REACH registration, the information generated by the registrant for the
CSA (depending on annual volumes) can support the Commission’s risk
assessment on fuel additives under the Quality of Petrol Directive.

EN

26

Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on theprotection of animals used for scientific purposes, OJ L 276, 20.10.2010, p. 33.

27

Directive 2009/30/EC of the European Parliament and of the Council of 23 April 2009 amending
Directive 98/70/EC as regards the specification of petrol, diesel and gas-oil and introducing amechanism to monitor and reduce greenhouse gas emissions and amending Council Directive
1999/32/EC as regards the specification of fuel used by inland waterway vessels and repealing
Directive 93/12/EEC, OJ L 140, 5.6.2009, p. 88.

13

ENPart I.
Operation of REACH

General Issues– Textile Names Regulation28: Article 25 of this Regulation requests the Commission
to examine possible hazards to human health in relation to allergic reactions andchemicals in textile products. To this end, the Commission is carrying out ascientific study to evaluate whether there is a link between allergic reactions andchemicals used in textile products and propose risk management measures, if
appropriate. The findings of this study would support the REACH risk
identification and management process; among others, such risk management
measures may include labelling to indicate the presence of potentially allergenic
chemicals. In order to identify which substances could cause allergic reactions andare used in textiles products, the study will make use of the information produced
under REACH for the registration, classification and use of substances.
– Paints Directive29: this Directive aims to limit the total content of VOCs in certain
paints and varnishes and vehicle refinishing products in order to prevent or reduce
air pollution resulting from the contribution of VOCs to the formation of
tropospheric ozone. These products are however also mixtures under REACH. The
solvents and other substances making up these mixtures are subject to REACH
registration which means that chemical safety assessments will have to be carriedout for these substances. Information available under REACH may thus be usefulfor the Commission in order to assess whether further measures to address VOC
emissions are needed, while the information collected under the Paints Directive
can inform exposure assessment under REACH CSA.
– POPs Regulation30: REACH registration requirements could help to identify POP
substances that could be candidates for nomination as POPs under the Stockholm
Convention.31 Substances listed in the Annexes to the Convention willsubsequently be added to the POPs Regulation.
– ELV32; WEEE33, Batteries34 and RoHS35 Directives: The process of identifying
additional substances of concern for management under the End of Life Vehicle,

EN

28

Regulation (EU) No 1007/2011 of the European Parliament and of the Council of 27 September
2011 on textile fibre names and related labelling and marking of the fibre composition of textile
products and repealing Council Directive 73/44/EEC and Directives 96/73/EC and 2008/121/EC of
the European Parliament and of the Council, OJ L 272, 18.10.2011, p 1.

29

Directive 2004/42/EC of the European Parliament and of the Council of 21 April 2004 on thelimitation of emissions of volatile organic compounds due to the use of organic solvents in certain
paints and varnishes and vehicle refinishing products and amending Directive 1999/13/EC, OJ L
143, 30.4.2004, p. 87.

30

Regulation (EC) No 850/2004 of the European Parliament and of the Council of 29 April 2004 on
persistent organic pollutants and amending Directive 79/117/EEC, OJ L 158, 30.4.2004, p. 7.

31

Council Decision of 14 October 2004 concerning the conclusion, on behalf of the European
Community, of the Stockholm Convention on Persistent Organic Pollutants, OJ L 209, 31.7.2006,
p. 1.

32

Directive 2000/53/EC of the European Parliament and of the Council of 18 September 2000 on
end-of life vehicles, OJ L 269, 21.10.2000, p. 34.

14ENPart I.
Operation of REACH

General Issues

Waste Electrical and Electronic Equipment, Batteries and Restriction of Hazardous
Substances Directives should benefit from the information generated by REACH.
– Water Framework Directive36: Data generated through the implementation of theWater Framework Directive and other water-related directives (monitoring, EQS)
can be used in carrying out REACH substance evaluations or when considering
possible inclusion of a substance on the candidate list or restriction of a substance.
Conversely, data from REACH registration dossiers and substance evaluations canbe used when implementing the Water Framework Directive.
– Industrial Emissions Directive37: Information on the substance under theregistration and authorisation procedures under REACH may be used to support
the development of BAT reference documents developed under the Industrial
Emissions Directive. The CSA comprises the complete life-cycle of the substanceand therefore includes the manufacture and use of these substances in industrial
installations covered by this Directive and measures to avoid and control
emissions.
– Construction Products Regulation:38 basic requirements for construction works aredefined in Annex I to this Regulation to be the basis for EU standardisation.
Accordingly, harmonised standards to be adopted or updated by CEN shouldreflect basic requirements for health and the environment. Such harmonised
standards will not address chemical safety as such, but will provide test methods
allowing manufacturers to show compliance with relevant chemicals legislation(e.g. REACH restrictions or the Water Framework Directive). Information
provided in accordance with Articles 31 or 33 REACH respectively may allow
compliance to be shown and thus obviate the need for testing according toharmonised standards; this is a synergy between REACH and the Construction
Products Regulation.

EN

33

Directive 2002/96/EC of the European Parliament and of the Council of 27 January 2003 on waste
electrical and electronic equipment, OJ L 37, 13.2.2003, p. 24.

34

Directive 2006/66/EC of the European Parliament and of the Council of 6 September 2006 on
batteries and accumulators and waste batteries and accumulators and repealing Directive
91/157/EEC, OJ L 266, 26.9.2006, p. 1.

35

Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the
restriction of the use of certain hazardous substances in electrical and electronic equipment, OJ L
174, 1.7.2011, p. 88.

36

Directive 2000/60/EC of the European Parliament and of the Council establishing a framework for
the Community action in the field of water policy, OJ L 327, 22.12.2000, p. 1–73

37

Directive 2010/75/EU of the European Parliament and of the Council of 24 November 2010 onindustrial emissions (integrated pollution prevention and control), OJ L 334, 17.12.2010, p. 17.

38

Regulation (EU) No 305/2011 of the European Parliament and of the Council of 9 March 2011
laying down harmonised conditions for the marketing of construction products and repealing
Council Directive 89/106/EEC, OJ L 88, 4.4.2011, p. 5.

15

ENPart I.
Operation of REACH

General Issues

For the Commission, it will be particularly important to take into account REACHgenerated data, and DNELs in particular, in developing EU lowest concentration ofinterest (LCI) values39 in the context of the Commission’s EU-LCI harmonised
framework for construction products.
Recommendations
1.1.

All efforts should be made to minimise or avoid potential overlaps through adoption oramendment of implementing legislation of REACH or of other EU sector specific legislation,
where possible

1.2.

Whenever the change of the guidance may address overlaps identified ECHA should consider
to carry out the necessary changes

1.3.

ECHA should develop a database listing existing restrictions in the EU legislation on asubstance base

39

EN

EU-LCIs are health-based values used to evaluate emissions after 28 days from a single productduring a laboratory test chamber procedure (as defined in the CEN TC 351 horizontal standard)
and are applied in product safety assessment with the ultimate goal to avoid health risks from longterm exposure for the general population. JRC ECA report no. 29 “Harmonisation framework forhealth based evaluation of building products indoor emissions in Europe (EU-LCI)” (Draft,
November 2012).

16

EN

Part I.
Operation of REACH

1.2.

General Issues

Definitions
The REACH definitions are a mix of well established notions and some newconcepts. Although few of them have been subject to in-depth discussions bystakeholders and Member States it is important to clearly distinguish between
issues related to the implementation of those definitions (which can beaddressed via guidance documents) and issues related to the definitions
themselves.

The definitions in REACH set out the information necessary to understand and apply
REACH correctly. They provide legal clarity in particular in those cases where a term
has several meanings in plain language, but must be understood in only one of them inthe context of REACH. This sub-title describes the experience acquired with thefunctioning of the REACH definitions and highlights those definitions which havebeen subject to extensive discussions or where the Commission observes potential
issues of concern. It is also important to mention that the definitions in Regulation(EC) No 1272/2008 (CLP)40 have been aligned with the REACH definitions.
The definition of substance (Article 3(1)) is the cornerstone of REACH, as
substances are the main subject of REACH provisions. The current definition has
been well-established in EU law for about 20 years. REACH took over the definition
from the predecessor chemicals legislation (Directive 67/548/EEC41 as amended by
Directive 92/32/EEC42). The definition of substance is closely related to theidentification of each specific substance. This is a crucial precondition for the correct
application of risk management measures under REACH (registration, authorisation,
restrictions). The Commission services note that substance identification is relevant,first, for the identification of the substance for regulatory purposes (e.g. authorisation,
restrictions) and, second, for the establishment of sameness of the manufactured orimported substance, mainly in the context of registration (in establishing Substance
Information Exchange Forums (SIEFs) among the potential registrants of the same
substance, joint submission or in the inquiry procedure)43. The Commission services
observe some practical problems mainly in the latter area. This is, however, in theCommission services' view not a problem of the definition of substance as such. The
issue is rather linked to the rules on the identification of the substance set out inEN

40

Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December
2008 on classification, labelling and packaging of substances and mixtures, amending andrepealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006,
OJ L 353, 31.12.2008, p. 1.

41

Council Directive 67/548/EEC of 27 June 1967 on the approximation of the laws, regulations andadministrative provisions relating to the classification, packaging and labelling of dangerous
substances, OJ 196, 16.8.1967, p. 1.

42Council Directive 92/32/EEC of 30 April 1992 amending for the seventh time Directive
67/548/EEC on the approximation of the laws, regulations and administrative provisions relating to
the classification, packaging and labelling of dangerous substances, OJ L 154, 5.6.1992, p. 1.

43

Study “Functioning of the European chemical market after the introduction of REACH”, CSES
commissioned by the European Commission, March 2012.

17

EN

Part I.
Operation of REACH

General Issues

Annex VI, Section 2 to REACH and in the Guidance on substance identification44 andto their application in different contexts of REACH (e.g. registration, authorisation).
The Commission services notes ECHA's invitation to consider issuing implementing
legislation which would ensure that substances of significantly different composition
are not merged into single dossiers45. It has to be noted that substance identification
has been given already considerable attention since the adoption of REACH and has
been dealt with within different guidance documents, frequently asked questions,other ECHA support tools, a number of conferences and meetings with different
industry stakeholders. The Commission services, ECHA and stakeholders willcontinue to explore the need for clarifying the existing framework for substanceidentification. In the registration area, part of the problem may be addressed by
Member State enforcement, in cases where it is evident that the provisions related to
substance sameness have not been complied with. In summary, the Commission
services consider that the efforts in this area (communications, meetings) should bemaintained involving stakeholders, Member States, ECHA and the Commission.
Additional clarifications will have a direct and positive impact on all REACH
processes (registration, evaluation, authorisation and restrictions).
The definition of mixture (Article 3(2)), apart from containing a circular reference tothe same word "mixture" after its alignment to GHS46 terminology through theamendment by CLP, is equally well-established in EU law and does not appear toraise problems in practice. Mixtures are formed by intentional mixing or blending ofat least two different substances and, contrary to substances, are not the result of achemical reaction.
The definition of article (Article 3(3)) has been subject to many discussions (e.g. on
candles, printer cartridges, alcohol testers, glow sticks) addressing borderline cases
between substances/mixtures in containers or carrier materials on the one hand, andarticles on the other. In order to determine whether or not an object fulfils thedefinition of an article under REACH, the object’s function and its characteristics
need to be assessed. This has been clarified to a large extent through the Guidance for
substances in articles47 and its appendices, also on the basis of industry providing
specific examples.
Another interpretation issue with respect to the definition of article arose in thecontext of provisions of Articles 7 and 33 with respect to the 0.1% threshold for
substances of very high concern (SVHC) in articles (see [Title 2]). It has been also
clarified that the definition of article does not cover buildings as long as they remain
fixed to the land on which they stand.

EN

44

Guidance for identification and naming of substances under REACH and CLP, Version 1.2,
Europan Chemicals Agency, March 201245

The Operation of REACH and CLP, European Chemicals Agency, 2011, p. 2

46

Globally Harmonised System of Classification and Labelling of Chemicals.

47

Guidance on requirements for substances in articles - Version 2, European Chemicals Agency,
2011

18

EN

Part I.
Operation of REACH

General Issues

The definition of manufacturer (Article 3(9)) triggered discussions mainly as far as
the concept of toll manufacturing (subcontracting) is concerned, as there may be alarge variety of different business arrangements in practice. The Guidance onregistration48 gives the basic elements as to the correct interpretation, while leavingsome flexibility for industry in specific cases to determine who should be considered
the manufacturer of a substance bearing the corresponding REACH obligations. The
Commission services consider this solution adequate.
The definition of importer (Article 3(11)), linked with the definition of import(Article 3(10)), is, at times, more difficult to apply to the multitude of practicalarrangements existing in practice. The definition of importer is linked to the
responsibility for the physical introduction into the customs territory of the EU, whichis already considered as placing on the market for the purpose of REACH. The
Guidance on registration and other ECHA tools provide help on the correctinterpretation of the definition. The Commission services consider this solution
adequate.
It is important to bear in mind that the REACH definition of placing on the market(Article 3(12)) is different from that definition in more recent pieces of EU
legislation, where placing on the market means only the first making available of a
product on the EU market. Therefore, the concept of placing on the market under
REACH applies at every step of the supply chain, unless otherwise specified (e.g. inseveral instances in Annex XVII).
The definition of distributor (Article 3(14)) does not pose problems in theimplementation of REACH. However, it should be noted that the reference to a
distributor acting for third parties is not interpreted to mean that this definition covers
only operators acting on behalf of others. The definition applies to every operator who
only stores and places on the market a substance, on its own or in a mixture.
Industry is often contesting the interpretation of the definition of intermediate(Article 3(15)), as clarified through the Guidance on intermediates49 in April 2010.
Differing interpretations of this particular definition may have had an impact onregistration dossiers submitted before the first registration deadline. ECHA’s
screening of over 400 registration dossiers submitted before the first registration
deadline of 201050 suggests that some registrants may have unduly benefited from thereduced registration requirements for intermediates set out in Articles 17 and 18. Thismay, however, mainly be an issue linked to the application of the criteria of thestrictly controlled conditions as set out in Articles 17 or 18, and not necessarily an
issue of a broader interpretation of the definition. The lack of agreement with industry
on the interpretation of the definition may have an impact when assessing whether ause of a specific substance included in Annex XIV is an intermediate use, andEN

48

Guidance on registration, Version 1.6, European Chemicals Agency, 2011

49

Guidance on intermediates, Version 2, European Chemicals Agency, December 201050

The Operation of REACH and CLP, European Chemicals Agency 2011, p. 14.

19

ENPart I.
Operation of REACH

General Issues

therefore not subject to the authorisation requirement. In that regard the Commission
services share ECHA's view on the need to further clarify this issue, in particular toclarify with industry which applications can be considered intermediate uses of a
substance in accordance with the interpretation set out in the Guidance onintermediates51.
With respect to the definition of phase-in substance (Article 3(20)), it is useful tonote that the criteria in subparagraphs b) and c) may be met only by certain operators,
while for other operators the same substance will be considered as non-phase-in
substance. The correct identification of the status of the substance has important
implications for the registration obligations. In this respect, the Commission services
highlight that a second corrigendum was published in the Official Journal concerning
the criteria for so-called "no-longer-polymers" in Article 3(20)(c)52.
It is useful to recall that the definition of use (Article 3(24)) is broad, i.a. including
storage or keeping of a substance. This was taken into account, e.g. when Annex XVII
to REACH, as taken over from the repealed Directive 76/769/EEC53, was reviewed
and amended by Regulation (EC) No 552/200954 and some restrictions were redrafted
accordingly.
The definition of exposure scenario in Article 3(37) is repeated in Annex I, Section
0.7 in analogous, but not identical words, which may be considered as superfluous. A
similar issue is noted with respect to the definition of use and exposure category(Article 3(38)), which is not consistently used in Annex I. In practice, these issues do
not pose any problems.
The scope of the definition of substances which occur in nature (Article 3(39)) was
further clarified through the Guidance for Annex V55, which states, in particular, thatliving or unprocessed dead organisms, or parts thereof, are not considered substancesEN

51

The Operation of REACH and CLP, European Chemicals Agency, 2011, p. 35-36.

52

Corrigendum to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of
18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction ofChemicals (REACH), establishing a European 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, OJ L 36, 5.2.2009, p. 84.

53

Council Directive 76/769/EEC of 27 July 1976 on the approximation of the laws, regulations andadministrative provisions of the Member States relating to restrictions on the marketing and use ofcertain dangerous substances and preparations, OJ L 262, 27.9.1976, p.201.

54

Commission Regulation (EC) No 552/2009 of 22 June 2009 amending Regulation (EC) No
1907/2006 of the European Parliament and of the Council on the Registration, Evaluation,
Authorisation and Restriction of Chemicals (REACH) as regards Annex XVII, OJ L 164,
26.6.2009, p. 7.

55

Guidance for Annex V Exemptions from the obligation to register - version 1, European Chemicals
Agency, March 2010

20

EN

Part I.
Operation of REACH

General Issues

under REACH. The definition of not chemically modified substance (Article 3(40))
was also further clarified through the Guidance for Annex V.
It is important to note that even if the definition of the term alloy (Article 3(41)) does
not specifically mention that an alloy is a mixture rather than a substance, recital (31)as well as Annex I, Section 0.11 and the Guidance on substance identification clarify
that alloys are special mixtures. Registration obligations related to substances inalloys are explained in the Guidance on registration.
At this juncture, the term nanomaterial is not defined in REACH, as it is not
specifically mentioned in the REACH text. The term has been recently defined in
Recommendation 2011/696/EU56 and should be also understood to apply in thecontext of REACH practical application as the Recommendation specifically isaddressed to Member States, the Union agencies (including ECHA) and economic
operators.
The application of REACH, in particular the delimitation of the REACH scope in
Article 2, depends also on the scope of some terms defined in other EU legal acts,
which are relied on in the interpretation of exemptions from the scope of REACH(e.g. the terms "food", "waste", "by-product", "temporary storage"). Therefore, it is
not necessary to define them in REACH.
Conclusions and recommendations
Overall, the definitions in REACH are fit for their purpose and function well. The
problems raised by some stakeholders concerning the definition of "substance" arerather linked to the issue of substance identification than to the definition as such.
The main difficulties related to the application of definitions have been observed inrelation to the definitions of "article" and "intermediate", as their interpretation is notuniversally accepted by all stakeholders. The interpretation of the definition of article
in connection with the obligations under Articles 7 and 33 is not accepted by someMember States and stakeholders. The interpretation of the definition of intermediate is
not entirely shared by industry. The Commission services are prepared to contribute to
the discussions with industry on the implementation of this definition.
It is important to note that REACH definitions differ to a certain extent from thealigned reference provisions for the internal market for goods, as set out in Annex I to
Decision No 768/2008/EC57. These were designed for EU harmonisation legislation
for products (e.g. definitions of "placing on the market", "manufacturer", "importer"and "distributor"). Recital (5) of Decision No 768/2008/EC recognises thatspecificities of sectoral needs may justify other regulatory solutions and explicitlyEN

56

Commission Recommendation 2011/696/EU of 18 October 2011 on the definition of nanomaterial,
OJ L 275, 20.10.2010, p. 38.

57

Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on acommon framework for the marketing of products, and repealing Council Decision 93/465/EEC,OJ L 218, 13.8.2008, p. 82.

21

EN

Part I.
Operation of REACH

General Issues

mentions chemicals. The Commission services therefore do not see a need forreviewing whether alignment to those definitions would be appropriate or not at thispoint in time.
Recommendations:1.2.1. The definitions in Article 3 have been found to be fit for their purpose and function well.
However, if at a later stage REACH will need amending for other reasons:a.

b.

definitions will be reviewed with the view to ensure better coherence between thereference provision in Decision No 768/2008/EC and REACH, if compatible with
REACH specific needs and those of Decision No 768/2008/EC.
consideration should be given to the introduction of the definition of a nanomaterial inline with Recommendation 2011/696/EU

1.2.1. Registrants are encouraged to apply the definition of intermediates, as set out in REACH andfurther explained in the Guidance on intermediates.

EN

22

EN

Part I.
Operation of REACH

2.

Registration

REGISTRATION
Despite numerous challenges encountered by all actors involved, the firstregistration deadline should be recognised as a success.

The "R" in REACH stands for Registration, one of the Regulation's core mechanisms.
In general, it requires companies to register all substances manufactured or imported
in quantities of one tonne or more per year. Registration shifts the burden from theregulator to the industry to demonstrate how substances can be used safely. The
registration obligation seeks to address the concerns detailed in the Commission
White Paper58 regarding the lack of information available on 99% of the volume ofchemicals on the market in the EU. Failure to register would result in a manufacturer
or importer being unable to legally manufacture or/and import their substance.
A registration dossier should demonstrate that the risks through the lifecycle of a
substance are controlled. The amount of information required for registration
increases along with the volume of the substance manufactured and/or imported.
Manufacturers and importers are required to submit a technical dossier for substances
registered in quantities of one tonne or more. The technical dossier contains
information on the physicochemical, toxicological and ecotoxicological properties, on
the uses and on the classification of a substance as well as guidance on safe use. For
substances registered at quantities of 10 tonnes or more per year, a chemical safetyassessment (CSA) also needs to be conducted and documented in a chemical safety
report (CSR) which accompanies the technical dossier.
For substances in specified hazard classes as well as for all substances that meet thecriteria for being persistent, bioaccumulative and toxic (PBT) or very persistent andvery bioaccumulative (vPvB) as set out in Annex XIII to REACH, the CSA includes
the development of exposure assessment and risk characterisation for manufacture
and all the identified uses of the substance.
REACH provides for the phased registration of substances already on the market in
the EU prior to REACH by the following deadlines, where the tonnages indicated are
per individual manufacturer/importer (Article 23):• by 30 November 2010:– Substances manufactured or imported in quantities of 1 000 tonnes or more
per year;– Substances meeting the criteria for classification as carcinogenic, mutagenic
or toxic to reproduction (CMR) category 1 or 2 (under Directive 67/548/EEC)
manufactured or imported in quantities of one tonne or more per year;– Substances meeting the criteria for R50/53 (under Directive 67/548/EEC)
manufactured or imported in quantities of 100 tonnes or more per year;
58

EN

White Paper - Strategy for a future Chemicals Policy, European Commission, {COM(2001)88
final}

23

EN

Part I.
Operation of REACH

Registration• by 31 May 2013:– Substances manufactured or imported in quantities of 100 tonnes or more peryear; and• by 31 May 2018:– Substances manufactured or imported in quantities of one tonne or more per
year.
In general, only companies who pre-registered their intention to register a substance at
ECHA between 1 June and 1 December 2008 can benefit from these deadlines.
Pre-registration was intended to facilitate the formation of Substance Information
Exchange Forums (SIEFs) and thus to increase the efficiency of the registration
system, to reduce costs and to avoid duplication of testing, especially testing
involving vertebrate animals, to allow downstream users to keep track of whether or
not their substances are likely to be registered and also to allow ECHA to anticipate
the volumes of registrations to be handled.
Not only due to an unexpectedly high number of pre-registrations but also because
registration would involve a large amounts of companies and substances, theCommission followed the process closely during the first years of implementing
REACH. Registration contributes to meeting the aims of REACH in a number ofways, directly and indirectly. Through the gathering of data and identification of risk
management measures on substances by registrants, better information on risk
management can be communicated throughout the supply chain notably on
occupational safety, fulfilling one the REACH objectives: to protect human health.
Environmental data included in CSRs can also help companies to reduce theenvironmental impact of their uses of substances, fulfilling another REACH objective:
to achieve a high degree of protection of the environment.
REACH introduced a harmonised set of rules for the management of chemicals in the
EU. REACH also strives to streamline existing regulatory requirements on chemicals,
making the circulation of chemical substances on the internal market easier andseeking to remove national obstacles thereto. Several instruments, e.g. exemptions forresearch and development or the tiered information requirements, should foster
innovation.
Pre-registration
ECHA reports that it received 2.7 million pre-registrations for 146 000 phase-in
substances. The number of pre-registrations was 15 times higher than expected59.
However, as there were no fees for pre-registration it appears likely that many
companies pre-registered substances before they were certain whether or not they had

59

EN

Originally it was estimated that 130 000 pre-registrations for 70 000 substances and intermediates
would be received. The source of this estimate is not specified in ECHA’s report on "The
operation of REACH and CLP 2011".

24

EN

Part I.
Operation of REACH

Registration

registration obligations (i.e. may have adopted a “just in case” approach at this stage),e.g. when their substances were re-imported, recycled, covalently bound during
polymer reactions or intentionally released from articles. This approach was supported
by guidance and information on the ECHA websites (FAQs). Whatever the reason,
the high number of pre-registrations led to a temporary overload of the ECHA ITsystems, and communications with industry on the system usability. Nevertheless,
ECHA managed to effectively process pre-registrations by reallocating resources60.
It was noted that 82% of the pre-registering companies indicated that they were SMEs
and 20 000 companies indicated an intention to register before the first deadline(covering approximately 250 000 pre-registrations). However, ECHA reported that
only 10% of pre-registrations for the 2010 deadline actually resulted in registrations
by that time. The large number of pre-registrations created confusion in the supply
chain as to the actual registration intentions and concerns among some downstream
users for a discontinuation of a supply of substances. Following the first registration
deadline, the Commission has not been presented with any significant evidence insupport of these concerns.
Due to the high number of pre-registrations, there were a number of instances where
discussions in SIEFs proved very difficult. In some cases, communication within
SIEFs broke down altogether. ECHA therefore implemented two additional tools for asmoother functioning: the pre-SIEF, where potential registrants could discuss on thesubstance identity upfront and find the correct SIEF more easily, and the SIEF
Formation Facilitator (SFF), who should initiate the first organisational discussions in
the SIEF. Both tools proved to be helpful, although some difficulties were observed,
especially with the SFF. The role of the SFF was often abused by certain actors, who
had a purely commercial interest in providing their services to other members of the
SIEF, or for the purposes of data collection. In some other cases, the SFF did notshow signs of activity which meant that other members of the SIEF had to initiate
discussions in the SIEF.
ECHA reported that insufficient evidence had been collected about this, making theintervention of Competent Authorities (CAs) impossible in terms of enforcement; The
Commission services are nevertheless of the opinion that industry should do its best to
eliminate these practices. Within the context of the Directors’ Contact Group (DCG see below), ECHA also pledged that it would investigate the possibility to improve
the REACH-IT pre-SIEF functionality with regards to personal data protection61. The
Commission services would support further efforts by ECHA to introduce
possibilities to screen abuses of REACH-IT for commercial purposes. The
Commission services consider that the possibility for a SFF to be replaced by anothermember of the SIEF could help solving this problem.

EN

60

Study “Review of the European Chemicals Agency”, PwC, commissioned by the European
Commission, March 2012.

61

See issue nr. 17 in "The Summary Paper on 28 issues and solutions" available onwww.echa.europa.eu.

25

ENPart I.
Operation of REACH

Registration

The communication in many SIEFs was especially slow in the beginning. A highpercentage of members did not respond to any communication at all. The industry
organisations reacted to this by establishing a "voluntary code", giving guidance to
SIEF members on how and to what extent they needed to get involved in the
preparation of a joint submission62. This proved to be a helpful tool in supporting anorganised and efficient SIEF process.
In order to address i.a. the above challenges, the Commission invited six selectedindustry organisations and ECHA to become members of the DCG. The DCG
monitored progress towards meeting the first registration deadline. It also sought toreduce practical obstacles to SIEF formation and registration of substances and toaddress foreseeable practical situations not detailed in REACH. The DCG gathered
important feedback on the industry’s daily work with REACH.
Registration
By the end of 2011, 27 418 complete registration dossiers had been submitted to
ECHA for 3 676 phase-in and 1 670 non-phase-in substances, so in total 5 346
substances.
By June 2011, ECHA checked approximately 400 intermediate registrations andconcluded that in 86% of the cases the conditions that allow claiming the provision of
reduced information requirements had not been sufficiently demonstrated or
justified63.
The vast majority of registration dossiers were submitted by large companies (87%).
Medium-sized companies had a share of 8%, small 4% and micro-enterprises only
1%. In total, 19% of the registrations were submitted by Only Representatives onbehalf of non-EU manufacturers. ECHA assessed the evidence provided for reduced
registration fees based on claimed SME status from 66 companies and found that 58%
had wrongly identified themselves as SMEs64.
Table 1 below outlines the number of registered substances per year and by type ofdossier.
Table 1. Number of submitted dossiers
Completed dossiers

2008

2009

2010

2011

Total

Registration of on-site isolated intermediates

12

85

1 373

2 394

3 864

Registration of transported isolated intermediates

46

196

3 426

546

4 214

Full registration dossiers

10

217

18 969144

19 340Total registrations

68

498

23 7683 084

27 418Source: ECHA, The Operation of REACH and CLP, p. 10, Table 1.

62

SIEF guidance – updated verson, CEFIC, September 2011, p. 19.

63

The Operation of REACH and CLP, European Chemicals Agency, 2011, p. 14.

64

EN

Idem..

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Part I.
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Registration

Overall, ECHA evaluates the registration process to date to have been a success, inpart thanks to the well-functioning IT-system. For the next deadline, ECHA intends tofurther streamline the IT processes and to develop additional tools. The work of the
DCG showed that the availability of the relevant (parts of the) IT tools in all EU
languages may be of importance to ensure access by companies, in particular SMEs,
to the tools needed for fulfilling REACH and CLP requirements. In addition, thecontinuous round-the-clock availability of REACH-IT in the period close to thedeadline will give companies additional work time to meet the deadline.
Looking ahead to future registrations, some potential registrants have raised the issueof the capacity of testing laboratories in the run-up to the next phase-in registration
deadline65.
Industry also reported, notably within the context of the DCG, that stability of
guidance documents published by ECHA was an important issue. As guidance isheavily relied on for compliance by industry, the Commission services also considers
that it should remain stable in the months preceding any registration deadline. In that
respect, ECHA introduced a six-month guidance moratorium on guidance documents
ahead of the 2010 registration deadline as part of the DCG solutions. ECHA intends torespect such moratorium also for the next deadlines.
An overview of the work of the DCG was published on ECHA’s website66. It consistsof practical solutions to obstacles to registration encountered by some potential
registrants in good faith ahead of the deadline.
Inquiry
ECHA's responsibility in the inquiry process is to bring together previous registrants
and new potential registrants of the same substance, to enable most efficient data
sharing. To do so, a potential registrant of a non-pre-registered phase-in substance or a
non-phase-in substance has to submit an inquiry to ECHA. In 2011 alone ECHA
received 1 970 inquiries, and managed to process about 2 100 (reducing the backlog
from previous year). With an increasing number of registration dossiers this process is
becoming more and more important and it will remain so especially after the last
deadline in 2018.
ECHA reported that close to the first registration deadline the number of inquiries
related to non-pre-registered phase-in substances suddenly peaked, while the qualityof the information on substance identification dropped. This led ECHA to reject manyinquiries. ECHA believes that some companies may have been acting under the false
impression that a submitted inquiry would remedy the fact that their substances had
not been pre-registered in due time67.

EN

65

Study “Technical assistance to prepare the Commission report on the operation of REACH”, RPA
and Ökopol, commissioned by European Commission, p.32

66

See Directors Contact Group webpage on [www.echa.europa.eu]

67

The Operation of REACH and CLP 2011, ECHA, p. 18.

27

ENPart I.
Operation of REACH

Registration

Industry members of the DCG reported that in some cases the inquiry process lasted
more than three months, which was considered too long and an obstacle to companies
to start the manufacture or import of substances. As a result, ECHA has streamlined
its internal processes and further improved the communication with companies about
required information, in particular on the substance identity. Inquiries were processedmore quickly as a result of the implementation of these changes.
ECHA is responsible for the decision regarding sameness of substances in the inquiry
process. In order to fulfil this responsibility ECHA is entitled to request from theinquirer all the information on the identity of the substance as specified in Annex VI,
Section 2 to REACH. However, bearing in mind the purpose of the inquiry, all theformal requirements of Annex VI, Section 2 may not always be necessary to establish
if the same substance has already been registered. The Commission services
recommend that ECHA takes previous registrants' discussions (e.g. in SIEFs) into
account when deciding on "sameness" under Article 26. Based on the observations sofar, the Commission services invite ECHA to bear this in mind and further monitor,
where appropriate and feasible, the efficiency of the inquiry process to avoid longwaiting periods for industry upfront.
Substances in articles
The definition of article (Article 3(3)) has given rise an interpretation issue in thecontext of provisions of Articles 7 and 33 with respect to the 0.1% threshold for
SVHC in articles. The Commission considers that the definition implies that objects
which at a certain step in their life-cycle meet the definition of article under REACH
cease to be individual articles once they are assembled into another article and should
be considered as components or parts of an article from that moment. The
Commission therefore does not consider that the definition allows parts of a more
complex article to be articles for the purpose of Articles 7 and 33. This view isreflected in the Guidance on substances in articles.
Nanomaterials
Nanomaterials are a heterogeneous group of materials, with some traditional highvolume commodity materials (e.g. carbon black, synthetic amorphous silica), with
newly developed medium volume applications such as paints or sunscreens, and witha wide range of new low volume technical and biomedical applications (e.g. catalysts,
batteries, solar panels, tumour therapies). The total annual quantity of nanomaterials
on the market at the global level is estimated at around 11 million tonnes, with amarket value of roughly 20bn €. Furthermore, products underpinned bynanotechnology are forecast to grow from a volume of 200 bn € in 2009 to 2 trn € in201568. These applications will be essential for the competitiveness of a wide area ofEU products in the global market and can provide basis for further innovation in a

68

EN

Ireland’s Nanotechnology Commercialisation Framework 2010 – 2014, Forfas. August 2010.
available on www.forfais.ie. The figures refer to the value of products into which nanomaterials
are incorporated based on Lux Research.

28

ENPart I.
Operation of REACH

Registration

wide range of other industries69. Currently, the direct employment in nanotechnology
is estimated at around 300 000 to 400 000 jobs in the EU.70 There are also many
newly founded SMEs and spin-off companies in this high technology area.
Nanotechnology has been identified as a key enabling technology (KET) by the HighLevel Expert Group (HLG) on Key Enabling Technologies.71
For a sustainable use of nanomaterials, their safety needs to be ensured in line withthe principles of REACH. This raises the question whether some properties ofnanomaterials are linked to hazards for human health and the environment not yet
addressed by REACH and whether the traditional risk assessment and management
approaches underlying the REACH chemical safety assessments are applicable tonanomaterials. This question is analysed in more detail in the Communication on theSecond Regulatory Review on Nanomaterials and the attached Staff Working Paper
on Nanomaterial Types and Uses, including Safety Aspects [insert quote].
The Regulatory Review concluded that: “In the light of current knowledge andopinions of the EU Scientific and Advisory Committees and independent risk
assessors, nanomaterials are similar to normal chemicals/substances in that some
may be toxic and some may not. Possible risks are related to specific nanomaterials
and specific uses. Therefore, nanomaterials require a risk assessment, which shouldbe performed on a case-by-case basis, using pertinent information. Current risk
assessment methods are applicable, even if work on particular aspects of risk
assessment is still required.”On that basis, the Second Regulatory Review on Nanomaterials concludes that
"Overall the Commission remains convinced that REACH sets the best possible
framework for the risk management of nanomaterials when they occur as substancesor mixtures but more specific requirements for nanomaterials within the framework
have proven necessary. The Commission envisages modifications in some of the
REACH Annexes and encourages ECHA to further develop guidance for registrations
after 2013". Therefore the Commission services consider that the known hazard andexposure patterns of nanomaterials do not require amendments of the basic REACH
rules or new legislation with a similar purpose as REACH.
However, while experience with existing registration dossiers shows that the basic
REACH chemical assessment framework is applicable and in principle can be used todemonstrate the safe use of nanomaterials there is a need for more clarity in theEN

69

For a list of effects and property improvements through nanotechnologies see Appendix 4 ofCommunication From The Commission […] Second Regulatory Review on Nanomaterials,
3.10.2012 {COM(2012)572}.

70

Final Report of the High-Level Expert Group on Key Enabling Technologies, European
Commission, June 2011, p. 13.

71

The High Level Expert Group on Key Enabling Technologies was established on 13 July 2010. It
was comprised of 27 members including representatives from EU member states, relevant
European industry, downstream industries, the research community and the European Investment
Bank. The mandate of the High-Level Group was for one year.

29

ENPart I.
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Registration

registration dossiers on how the safe use of nanoforms is ensured. As a first step,
ECHA has provided further guidance which is now available to companies. Moreover,based on available information on technical progress, including the REACH
Implementation Projects on Nanomaterials and experience with the current
registration dossiers, there is a need to assess relevant regulatory options in particularpossible amendments of REACH Annexes to ensure clarity on how nanomaterials are
addressed and safety demonstrated in registration dossiers. This should take into
account in particular:•

current knowledge about risks of nanomaterials compared to conventional
substances and potential risks due to lack of knowledge,•

the potential negative effects of unclear regulatory requirements onenvironment and health,•distorting effects on competition between companies resulting from unclear
requirements,•

identified information gaps in registration dossiers and impacts of modified
requirements, including on SMEs.

For that reason, the Commission services will carry out an impact assessment to
identify the most efficient measures to address those issues.
Review of Registration requirements for substances in 1 – 10 tonnes
The Commission has reviewed the current registration requirements for substances
registered in quantities greater than or equal to one tonne and less than 10 tonnes per
year per manufacturer or importer (1 to 10 tonne substances). These requirements arebeing assessed for their likely ability to identify hazardous properties of relevance tothe protection of human health and the environment bearing in mind the impact on theinnovation and competitiveness of the EU market. This assessment includes
consideration of the identification of human health or environmental classification
endpoints sufficient for classification under CLP, especially for CMR endpoints, plus
consideration of the identification of potential PBT/vPvB substances.
Options for the adaptation of the current registration requirements have beendeveloped to reflect both increasing and reducing the registration requirements for 1
to 10 tonnes substances. Reduced requirements include considerations about
requirements set out for on-site isolated intermediates, and limiting the generation ofAnnex VII information to that currently available or capable of estimation byalternative methods (including read-across and (Q)SARs). Increased requirements
include the addition of selected Annex VIII endpoints of relevance to theidentification of C, M, R, P and B properties, and the adoption of the registration
requirements for 10 to 100 tonne substances (Annex VIII with and without
CSA/CSR).

EN

30

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Part I.
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Registration

Conclusion and recommendations
The Commission has reviewed the experience gathered during the pre-registration andfirst registration phases. These processes were new for all stakeholders involved in
REACH. Both industry and authorities (in particular ECHA) invested considerably
ahead of the deadline by setting up tools and allocating resources to meet thechallenge of the first registration deadline. The first registration deadline involved
submission of a high number of dossiers and its relative success reflects good
cooperation and goodwill from all the involved parties. Particularly the DCG has
given important feedback on the industry’s daily work with REACH.
In conclusion, REACH registration was a success. Registration dossiers were
submitted on time, showing that industry complied with the registration obligationand set up the right tools to prepare for registration. ECHA handled the firstregistration deadline effectively; a high number of registration dossiers were received
and the IT system functioned well on ECHA’s side. However, together with industry(e.g. through the DCG) further improvements can be made in preparation of the next
registration deadlines.
Recommendations
2.1. Concerning intermediates, as highlighted by ECHA, there is a need for awareness-raising acrossindustry, including a need to encourage updating of registration dossiers.
2.2. The DCG will continue to monitor preparedness of the industry ahead of the next registration
deadline. It is recommended that the DCG continues to examine practical issues linked withregistration and falling under its mandate.
2.3. Companies should continuously monitor and, where necessary, update their registrations.
Equally, any non-compliant dossiers must be brought into compliance.
2.4. Without prejudice to the Commission's legal interpretation of the current legal text on substancesin articles in connection to Articles 7 and 33, Member States and stakeholders are invited toprovide evidence on what potential environmental or other problems the current REACH
provisions on substances in articles.
2.5 Concerning the registration requirements for substances in volumes between 1 to 10 tonnes,
there is currently insufficient evidence to justify an alteration of the information requirements.
The review has raised a number of issues that call for further investigate in follow up to theCommunication on the review of REACH.

EN

31

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Part I.
Operation of REACH

Data sharing and avoidance of unnecessary testing

3.

DATA SHARING AND AVOIDANCE OF UNNECESSARY TESTING

3.1.

Data sharing
Sharing of data served well both the animal welfare and economic objectives,
however, joint registration increased the risks of inappropriate use of
substance sameness.

One of the objectives of REACH is to avoid unnecessary testing, especially vertebrate
animal testing, whilst generating the necessary information to identify the hazards ofsubstances and manage the resulting risks. In order to avoid animal testing, tests onvertebrate animals shall only be undertaken as a last resort, as per Article 25 of
REACH. To meet this objective as well as to increase the efficiency of registrationand thus lower costs for enterprises, REACH provides for pre-registered and non-preregistered substances72 two similar data sharing mechanisms.
Data must be shared for the same substance in the case of information involving tests
on vertebrate animals. Before carrying out tests on vertebrate animals, a potential
registrant must make sure that information is not already available from a previous
registrant. This is done in a Substance Information Exchange Forum (SIEF) for preregistered substances or through the inquiry process for non-pre-registered substances.
Information not involving tests on vertebrate animals must be shared if requested by apotential registrant of the same substance. The data sharing mechanisms aim to ensurethat studies which are already available are shared and that their related costs areagreed and shared amongst potential and previous registrants in a fair, transparent andnon-discriminatory way. Importantly, in the case of lacking data, the aim of the
sharing mechanism is for potential registrants of the same substance to agree who will
undertake the necessary testing to ensure that the test is carried out only once.
In accordance with REACH, ECHA has set up procedures to assist in the resolution ofdata sharing disputes, as per Article 27(7) for non-pre-registered substances andArticle 30(5) for pre-registered substances. They should be initiated as a last resort,i.e. after informal means of resolution have not brought results.
Data sharing plays a crucial role in REACH implementation as it facilitates
registration, thereby fulfilling the aims of REACH. The Commission examinedseveral steps of the data sharing process. Registrants of the same substance under
REACH ideally have to submit their registration jointly, in line with the so-called"one substance, one registration" (OSOR) principle.
In case of pre-registered substances, the potential registrants first must form a SIEF
and then designate a lead registrant. These two activities place a lot of responsibilityon the industry as REACH does not prescribe any formal structure for SIEFs. In otherwords, it is up to the SIEF participants to decide on the sameness of their substanceidentity and set their internal rules and organisation while respecting EU law

72

EN

Non-pre-registered substances can be: 1) phase-in substances which were not pre-registered, and 2)
non-phase-in substances.

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Part I.
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Data sharing and avoidance of unnecessary testing(especially competition law). As a third step, SIEF participants must ensure efficient
sharing of test data for the purposes of registration.
In case of non-pre-registered substances, the new potential registrant has to contact
ECHA with an inquiry providing, i.a., relevant information on the identity of his
substance, to enable ECHA to identify previous registrants for the purpose of sharing
existing data. The potential registrant may use any study summary or robust study
summary which has been submitted in the context of a registration at least 12 years
previously without financially compensating the previous registrant(s).
Substance identity and samenessThe determination of sameness of substances based on their individual substanceidentities following the requirements of Annex VI, Section 2 is central in theestablishment of SIEFs for phase-in substances and is applied in the inquiry process
for non-pre-registered phase-in and non-phase-in substances. Since one of the main
objectives of REACH for registration and the inquiry process is data sharing including
the reduction of testing costs and avoidance of unnecessary testing in general andespecially on vertebrate animals, it follows that enabling effective data sharing is
crucial in the process of determining the sameness of substance identity.
Determination of sameness of the identity of two or more substances based solely on
the strict comparison of the set of information gathered pursuant to Annex VI, Section
2 often creates inefficiencies as to the transmission of information on substances.
Smooth and efficient data sharing should be the main objective of this exercise.
However, each registrant needs to carry out an appropriate scientific and technicalexercise to ensure that submitted test data covers the hazards and risks of thesubstance in all the forms he manufactures, imports and places on the market for all
his identified uses.
Determining substance identity and sameness has proven to be a complex task
strongly based on case-by-case decisions. The Commission services will, together
with ECHA and industry, further work on more refined support to further enhance theidentification of substances and the efficiency of data sharing.
Expectations
Expectations ahead of the first registration deadline pertained to how efficiently SIEFs
were managed by the industry, which can be measured concretely by the actual
reduction of tests and costs that SIEFs achieved and by the number of disputes
referred to ECHA. Another important area of expectation was the efficiency of SIEFs
in nominating lead registrants and the efficiency of their members in the actual
sharing of data. On this last point, particular attention is paid below to the ease ofavailability and use of letters of access.
Findings
It was recognised by all actors that difficulties arose in the designation of leadregistrants and that a certain number of registration dossiers had been either subject to

EN

33

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Part I.
Operation of REACH

Data sharing and avoidance of unnecessary testing

opt-outs or submitted by registrants separately73. ECHA noted in particular that there
had been difficulties in designating lead registrants because of the high workload
involved and a general lack of understanding of the lead registrant’s obligations. The
late submission of lead dossiers also caused time pressure on other SIEF registrants.
Several solutions outlined by the DCG were developed and implemented by ECHA toaddress these problems.
The Commission services consider that lead registrant issues need to be further
monitored. ECHA indicated that it would focus its 2013 communication campaign on
the obligation to submit registration dossiers jointly74. In addition, ECHA suggested
that lead registrants should be legally obliged to make themselves known to ECHA
ahead of registration deadlines75. The Commission services would support amechanism to make lead registrants automatically known to ECHA, through e.g. an
IT facility.
After pre-registration, industry was required to form SIEFs and 2 176 lead registrants
identified themselves voluntarily to ECHA. ECHA reports76 that in practice SIEFs
appear to have suffered due to the large number of (potential) members, making
communication and cooperation complex and resource-intensive and causing delays.
This assessment of the operation of SIEFs is shared by the DCG, which also indicatesthat SIEFs present specific additional challenges for SMEs who have fewer resources
and, hence, are more vulnerable to unequal treatment and language barriers77.
Moreover, SMEs generally cannot invest as much time in REACH-related work as
bigger companies, which has in certain cases had an impact on the functioning of
SIEFs.
Only a small number of data sharing disputes have been forwarded to ECHA and all
were resolved within the deadlines. ECHA believes that the existence of the disputesettling mechanism has encouraged data sharing in the SIEFs. However, ECHA notesthat penalising breaches of data sharing obligations is difficult due to the different
organisation of enforcement authorities in the Member States. Concerns regarding
breaches of competition rules and abuse of the dominant position of some companies
within SIEFs and in consortia78 respectively were reported79, but could not be
substantiated by robust evidence. Often high and opaque costs of letters of access

EN73

The Operation of REACH and CLP, European Chemicals Agency, 2011, p. 11-12.

74

Ibid., p. 13.

75

Ibid., p. 18.

76

Ibid., p. 1.

77

Most SIEFs use English as the working language.

78

Consortia are legal constructs based on a contractual agreement between the parties involved.
REACH does not introduce this concept.

79

Study “Functioning of the European chemical market after the introduction of REACH”, CSES,
commissioned by the European Commission,.

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Part I.
Operation of REACH

Data sharing and avoidance of unnecessary testing

were a particular concern for small firms, which can be mitigated by higher degree oftransparency.
It was reported that nearly 90% of all dossiers were submitted jointly, resulting in a
total of 2 945 lead dossiers and 19 610 member dossiers (the average ratio of member
to lead dossiers was 6.7), leading ECHA to consider the joint submission process tobe generally working well.
Opt-outs from joint submission for one or more endpoints were noted in 135 cases
across all dossiers. Of all dossiers in the range ≥ 1000 tonnes per year considered, 82
dossiers covering 60 substances included opt-outs. Opt-outs related to a total of 1 437
endpoints; typically two opt-outs were included per dossier. Furthermore, ECHA
received either multiple joint submissions (of lead and joint dossiers) or more than
one individual (lead) dossier, as well as a joint submission for 250 substances and isinvestigating the reasons for this. On the basis of these outcomes, the Commission
services will be working with ECHA to identify measures to eliminate suchduplications.
Conclusions and recommendations
The data sharing provisions fulfilled the expectations with regard to the animal
welfare and minimizing costs of data collection for the industry. However, there areparticular difficulties in meeting the REACH objectives with regard to demonstrating
safe use in cases where results of alternative methods are not sufficiently scientificallyargued. The signals of misuse of the position of lead registrants with regard tomember applicants – in particular to SMEs are also of particular concern.
The processes so far have shown also that the definition of substance identity and thedetermination of sameness of substances are some of the most challenging aspects of
REACH. The Commission services will keep working on improved practicalimplementation to further enhance the identification of substances and the efficiencyof data sharing.
Recommendations
3.1.1. As to the difficulty in nominating lead registrants in SIEFs, ECHA is invited to consider
initiatives to promote early submission of lead dossiers and to raise the awareness of member
registrants on the timing of dossier submission.
3.1.2. All activities by ECHA and industry are welcome that help to disseminate "best practices" in
SIEFs, including developing IT solutions for improving transparency and communication within
SIEFs. Specific support to SMEs is crucial and industry is invited to issue targeted guidance forthese businesses. Efforts to make guidance available in more languages are also important for
SMEs to be able to fully participate to the data sharing process under REACH. This requires
involvement of industry as well as of ECHA.
3.1.3. Industry should work on best practices concerning the transparency of costs for letters ofaccess and the functioning of consortia. As problems of compliance with competition law rules
as well as good practice as to the dissemination of confidential business information within
SIEFs have also been identified, it is recommended that industry associations work on raisingawareness on these rules and principles to the benefit of their members.
3.1.4. ECHA and industry are invited to provide further guidance to companies and authorities for
substance identity and the determination of sameness.

EN

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Part I.
Operation of REACH

3.2.

Data sharing and avoidance of unnecessary testing

Avoidance of unnecessary testing
Significant amount of data used in the registration exercise did not require
additional testing on animals, however, progress achieved in some moreelaborate alternative testing methods was slower then expected

Article 25 provides that testing on vertebrate animals to generate information may
only be undertaken as a last resort and that it is necessary to take measures to limit the
duplication of other tests. It also provides that sharing and joint submission of data
shall concern technical data and in particular information related to the intrinsic
properties of substances. Article 40 outlines the process for the examination of testing
proposals for provision of information specified in Annexes IX and X for a substance.
In addition, REACH implements the principles of replacement, reduction or
refinement (3Rs) as set out in Directive 2010/63/EU80 in the use of testing and test
methods involving vertebrate animals laid down in Regulation (EC) No 440/200881.
These tests and test methods are used to provide data to address the information
requirements for substances manufactured or imported in quantities of one tonne ormore as set out in Annexes VII to X of REACH.
Information on intrinsic properties of substances may be generated by means otherthan tests, provided that the conditions set out in Annex XI are met. In particular forhuman toxicity, information shall be generated whenever possible by means otherthan vertebrate animal tests, through the use of alternative methods.
Annex XI provides general rules for adaptation of the standard testing regime set out
in Annexes VII–X where testing may not be scientifically necessary, including the useof existing data, weight of evidence such as the use of newly developed test methods
recognised by the Commission or Agency as being equivalent, (Q)SAR, in vitro
methods and grouping of substances and read-across approach There are also specificprovisions for adapting information requirements as set out in Annexes VII-X.
Expectations
The provisions on mandatory data sharing of test data generated on vertebrate animals
leading to joint submission of information were expected to make the biggest impact
on the avoidance of unnecessary animal testing. Further impact was expected from theuse of Annex XI and the submission of testing proposals prior to conducting new teston vertebrate animals.
The use of existing data was expected to provide the most instant impact on the
avoidance of unnecessary testing. The major question in relation to existing data is its
quality and subsequently its applicability to address information requirements.

EN

80

Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on theprotection of animals used for scientific purposes, OJ L 276, 20.10.2010, p. 33.

81

Commission Regulation (EC) No 440/2008 of 30 May 2008 laying down test methods pursuant toRegulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration,
Evaluation, Authorisation and Restriction of Chemicals (REACH), OJ L 142, 31.5.2008, p. 1.

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Data sharing and avoidance of unnecessary testing

It was expected that the use of weight of evidence, in vitro methods and (Q)SAR
would need to be developed and improved, and therefore would not make up a highpercentage of the alternative methods approaches at this point in time82. It was also
expected that there would be a need to educate and further develop guidance forregistrants and regulators to support the use and preparation of justifications for suchapproaches and also to promote regulatory acceptance.
Findings
90% of registration dossiers were submitted jointly. This confirms the success of thedata sharing and joint submission schemes.
Of the 14 875 dossiers for phase-in substances registered by end of February 2011 inamounts of 1 000 tonnes or more per year, there were only 19 opt-outs concerning
endpoints that would have required animal testing. Endpoint study records show thatfor substances in volumes of 100 tonnes or more, registrants used data generated prior
to the introduction of REACH as their main source of data83. The second most usedsource of information was the application of read-across, especially for endpoints thatwould otherwise require longer-term animal studies. This indicates that the use of theremaining alternative methods (see figure below) to address endpoints is only adeveloping area and that mainly existing data is used to fulfil information
requirements.
Figure 1. Data Sources for Registration Dossiers84
60

Percentage

50
40
30
20
10
Existing
data

Readacross

Data
Omission/
Waiving

Weight of
Evidence

Other
Approaches

Testing
Proposals(Q)SARS0

Other approaches have been flagged by Registrants as "other information" but this has
not been specified in the ECHA report.

EN

82

Commission Staff Working Paper, [REACH] Extended Impact Assessment, COM(2003)644 final,
29.10.2003

83

The 100 tonnes data was used as a reference point in the The Use of Alternatives to Testing on
Animals for the REACH Regulation published in 2011 by ECHA [www.echa.europa.eu]

84

Based on ECHA's Report "The use of alternatives to testing on animal for the REACH regulation"

37

EN

Part I.
Operation of REACH

Data sharing and avoidance of unnecessary testing

In total, 574 testing proposals were received covering 1 175 tests, of which 711
related to in vivo vertebrate animal studies. The operation of the Member State
Committee dealing with testing proposals was successful. ECHA noted that a main
issue is information quality and that the quality of justifications for not conducting
tests (including animal tests) may be insufficiently robust in some registration
dossiers. Furthermore, ECHA indicates that a reduced number of testing proposals
were received due to the (inappropriate) use of alternative approaches. ECHA also
reports that 107 higher tier animal tests seem to have been conducted without priorsubmission of a testing proposal85.
In 27 public consultations on testing proposals conducted by ECHA as part of its
dossier evaluation activities, no information was obtained from third parties that could
be used to fulfil the respective data requirements86.
The percentage of endpoints that were filled with information from experimental
studies (ES), testing proposals (TP) or by use of alternative methods (AM) is provided
in Table 2. The column “no data” (ND) applies when information is not required (e.g.
because no positive test results triggered the need to conduct further tests).
In summary, registrants have extensively used Annex XI of REACH to waive testing.
Table 2. Share of information types used to fulfil obligations for the different
endpoints% ES87

% TP

% AM

% ND

Acute Toxicity

85

-

15

-

Skin Irritation

78

-

22

-

Eye Irritation

75

-

25

-

Skin Sensitisation

63

-

37

-

Repeated Dose Toxicity

67

7

26

-

Genetic Toxicity In Vitro

77

-

23

-

Genetic Toxicity In Vivo

41

-

32

26

Toxicity To Reproduction

42

10

48

-

Developmental Toxicity

47

10

43

-

88

-

Endpoint

Bioaccumulation Fish

15

-

85

Toxicity to Fish

75

-

25

-

-

89

-

Long-term Toxicity to Fish

85

EN

16

82

Ibid.

86

Study “Technical assistance to prepare the Commission report on the operation of REACH” RPA
and Ökopol, commissioned by the European Commission.

87

Experimental studies include in vivo and, where validated, in vitro studies.

88

Experimental studies on invertebrates were counted as alternative methods.

89

Justification for omission.

38

ENPart I.
Operation of REACH

Data sharing and avoidance of unnecessary testing

Long-term Toxicity to birds

7

-

9290

-

Long-term Toxicity to Mammals

1.8

-

7

91

Toxicity to Other Terrestrial Organisms

4

-

4

92

Source: The Use of Alternatives to Testing on Animals for the REACH Regulation 2011, European Chemicals Agency,
Section 3, pp. 45 – 47.

Development and encouragement of alternatives
ECHA is actively supporting the development of alternative methods by contributing
to and hosting the OECD QSAR toolbox and by cooperation with the JRC
Computational Toxicology Group to promote the use of computer-based prediction
methods. The Commission’s Joint Research Centre (JRC) compiles the (Q)SAR
models and administers the (Q)SAR Model Reporting Format Inventory to promote
the use of alternative methods. The database is available at the JRC website and is
free of charge. ECHA also disseminates information from the endpoint summary
records in order to help future registrants to source information that can be used to
predict the properties of their substances by read-across or (Q)SARs.
In September 2010, ECHA organised a workshop to clarify uncertainty with regard to
the use of non-test methods and develop a common understanding on the use of thesemethods in the regulatory context. ECHA did not provide any quantification of its
support of the development of alternative methods91. ECHA is however conducting an
ongoing programme looking at inter alia the evaluation of alternative test methods andparticipates in the development of test methods and guidance documents in thecontext of the OECD.
20 Member States appear to have made contributions from public funds to EU and/orOECD work on the development and validation of alternative test methods with 17Competent Authorities (CAs) providing quantification, as set out in Table 392.
Overall however, due to inconsistencies between information provided by different
CAs, it was not possible to establish a robust estimate of the overall funding patterns
for 3R research from the Member States reports discussed in [Title 10].
Table 3. Member State funding for national R&D of alternative testing
methodologies86
Level of Funding (Euros per year)

EN

Member state

0 to 10 000

CY, LI, LV, PL, SI and IS

10 001 to 100 000

BE and CZ

100 001 to 1 000 000

BG, DK, ES, FR, NL, SE, UK and NO

More than 1 000 000

DE90

Currently the share of information provided by (Q)SARs is only 0.5% of all registration dossiers.

91

The Operation of REACH and CLP, European Chemicals Agency, 2011.

92

Study “Technical assistance to prepare the Commission report on the operation of REACH”, RPA
and Ökopol, commissioned by the European Commission.

39

ENPart I.
Operation of REACH

Data sharing and avoidance of unnecessary testing

Reflecting its strong commitment to alternative methods to animal testing, theCommission made available funding of about € 330 million in the years 2007 to 2011.
Research activities account for the biggest part of the total budget with around € 290
million spent on projects through the 6th and 7th Framework Programmes (FP6/FP7)
and the LIFE+ Programme. These funds always needed to be complemented by own
resources of the funded entities and, in addition, triggered the spending of further € 25
million from industry through a public-private partnership initiative.
Table 4. Overview of projects on alternative methods/approaches funded by the
Framework Programmes (FP6/FP7)
Name

Period
2015
2014
2013
2012

2011

2010

2009

2008

2007

2006

2005

2004

Total awarded grant[million €]FP6
Predictomics
CONAM
NOMIRACLETOXDROP
ReProTect
ACuteTox
MODELKEY
Sens-it-iv
EXERA
CAESARVITROCELLOMICSMEMTRANSEUPRIM-NET
carcinoGENOMICSNANOSHDIPNA
NanoInteract
Cellnanotox
SCARLETInViToPharma
INVITROHEARTEART
LINTOPForInViTox
ARTEMISCOMICSOSIRIS

2.3
0.15
10
1.6
9.1
9.0
8.4
11.0
2.2
1.5
2.9
1.9
4.8
10.4
2.4
2.8
3.3
2.6
0.11
0.58
2.7
2.9
0.29
2.0
2.2
10.0

FP7
START-UP
CONTAMED
REEF
NANOMMUNE *NanoTEST *OpenTox
DEER
NEURONANO *NANORETOX*ESNATS
PREDICT-IV
NANODEVICE *ENFIROENNSATOX *ENPRA *

EN

0.32
3.5
2.9
3.4
3.0
3.0
3.5
2.5
3.2
11.9
11.3
9.5
3.2
2.8
3.7

40

EN

Part I.
Operation of REACH

INLIVETOX *NEPHHHINAMOX *CADASTERRISKCYCLESYSTEQEUROECOTOXACROPOLIS
NANOHOUSEAXLR8CHEMSCREEN
SCR&Tox
HeMiBio
DETECTIVECOSMOSNOTOX
ToxBank
COACH

Data sharing and avoidance of unnecessary testing

*

**
**
**
**
**
**
**

QNANO *
ModNanoTox *NanoTranskinetics *Marina *NanoValid *Nanoreg *NanoMile *NanoSolutions *Modern *Mod-ENP-Tox *NanoPuzzles *PrenanoTox *MembraneNanoPart *Total FP6 + FP7

2.4
2.5
2.3
2.7
1.0
2.7
1.0
3.0
2.4
0.56
3.5
4.7
4.7
4.3
3.3
4.9
1.6
1.5
7.0
1.0
1.0
9.0
9.6
10.0
9.6
10.0
1.0
1.0
1.0
1.0
1.0
287.0

The projects given above and marked with one or two asterisks form part of two research clusters as follows:*
NANOSAFETY cluster**
SEURAT-1 cluster, the funding of which was realized via a joint venture between the European Commission (inthe framework of FP7) and the European Cosmetics Association (COLIPA), each having awarded € 25 million. Thus, on
top of the sum mentioned above (€ 196.9 million) COLIPA made available additional € 25 million.

The second most important fraction (about € 40 million) was spent for theCommission’s European Reference Laboratory (EURL) for Alternative Methods toAnimal Testing (ECVAM), hosted by the Commission's JRC. Around a further € 2
million went into various other test methods-related activities of the Commission.
Numerous alternative methods have already been developed and many of them havebeen validated by EURL ECVAM and/or accepted at international level (OECD).
A number of alternative methods have been developed for the different application
fields and with the current advancement of toxicological sciences they emerge at anincreasing rate. However, the development of non-animal alternative methods
represents a considerable scientific challenge.
During the period 2007-2011 EURL ECVAM received 48 test methods for evaluationand finalised the validation of seven alternative methods. At present, 10 methods
undergo validation studies for which ECVAM has the lead and additional six methods
are validated by other organisations with the support of ECVAM. In the same period
the peer review of 15 methods by the ECVAM Scientific Advisory Committee(ESAC) was completed and the peer-review currently is in progress for additional
three methods.

EN

41

EN

Part I.
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Data sharing and avoidance of unnecessary testing

The introduction of 3 test methods into Regulation (EC) N°440/2008 was
accomplished in period 2007-2011 and the international acceptance of 6 test
guidelines by the OECD Test Guidelines Programme was also achieved. They belong
to the fields of acute oral toxicology (1), genotoxicity (1), skin sensitisation (1) andskin irritation (1) as well as eye irritation (2). Several other OECD Test Guidelines,
e.g. in the fields of eye corrosion/irritation and carcinogenicity, are underdevelopment.
In some toxicological areas relevant to REACH, such as skin irritation and corrosion,
full replacement has been achieved. However, other more complex toxicological
endpoints still lack sufficient alternatives to animal testing as science is not yetadvanced as in the other areas. In particular, there are five areas of concern, i.e.
toxicokinetics, repeated dose toxicity, carcinogenicity, skin sensitisation andreproductive toxicity, in which further efforts in research are needed. In the context ofnanomaterials, further adjustment of the OECD Test Guidelines is currently being
discussed by the OECD Working Party on Manufactured Nanomaterials (WPMN).
Eight test guidelines have been identified as requiring adaptation. A dedicatedworking group within WPMN is examining the applicability of alternative testing
methods to nanomaterials.
In addition, a gap between the outcome of research projects in terms of developed test
methods and the fitness for application of such methods in practice is evident. Many
new methods need further optimisation and adaptation to the need of the users. A
suitable funding strategy for optimisation activities, however, is lacking, both at EU
and Member State level.
At the regulatory level, animal tests have a long history of application leading to much
experience in interpreting results. In contrast to this, the majority of in vitro and in
silico methods as well as the read-across approach referred to in Annex XI to REACH
have not yet reached this status. It will therefore take further efforts to build up thesame level of confidence for alternative methods and, subsequently, improve theacceptance by regulators.
Further gaps may become evident through the AXLR8 project93 that has the objective
to monitor the progress of EU-funded FP6/FP7 research projects aimed at thedevelopment of alternative testing methods, to identify gaps in knowledge, to define
priority research needs, and to prepare, publish and disseminate progress reports on anannual basis.
Today, toxicology is undergoing a transition towards a more mechanistic, pathwaybased, cell- and computer-based approach assessing a substance’s toxic mode ofaction. As current approaches do not always provide the complete mechanistic
information on how the chemicals exert toxicity, large uncertainties remain in
extrapolating data across dose, species and life stages. It is therefore necessary to

93EN

FP7 project "Accelerating the transition to a toxicity pathway-based paradigm for chemical safetyassessment through internationally coordinated research and technology development (AXLR8)",
http://axlr8.eu/

42ENPart I.
Operation of REACH

Data sharing and avoidance of unnecessary testingdevelop a robust understanding of the networks of biological pathways – many ofwhich are not yet described in full. Although several initiatives already focus on thepathway-based approach (e.g. the SEURAT-1 cluster94), much remains to be done inthis direction. A strategic, international and cross-sectoral approach would be themost suitable manner of advancement.
The European Partnership for Alternative Approaches to Animal Testing (EPAA) is avoluntary collaboration between the European Commission, European tradeassociations, and companies from seven industry sectors. The aim of the EPAA is topool knowledge and resources in order to accelerate the development, validation andacceptance of alternative approaches to further the replacement, reduction andrefinement (3Rs) of animal use in regulatory testing.
Conclusions and recommendations
There is good progress on the procedural side of data sharing and with submission of
testing proposals. However, there are concerns regarding the robustness of theinformation and the quality of justifications submitted to address information
requirements, which may bring the dossier into non compliance with the information
requirements.
Overall, an allocation of € 330 million has been made available by the Commission todevelop and evaluate alternative methods in the period 2007-2011. There are stillfundamental gaps in providing alternatives for some complex toxicological endpoints.
In addition some research outputs are produced which are not suitable for regulatoryneeds or which require further education of users and regulators to ensure their use
and acceptance.
Recommendations
3.2.1. ECHA should take measures so that registrants improve the quality of the justifications
supporting the alternatives to animal testing, so as to improve compliance of registered dossierswith the information requirements.
3.2.2. ECHA should continue to provide guidance and training to registrants and regulators to assist in
the use, preparation of justifications and regulatory acceptance for approaches such as weight ofevidence, grouping of substances and read-across approach and the use of (Q)SAR and in vitro
methods.
3.2.3. The effectiveness of research funding for the development of alternative methods will beenhanced by strategic concentration. It is also of value to coordinate internationally and acrosssectors to avoid the repeat of alternative method-related projects that are ongoing in otherjurisdictions and sectors.
3.2.4. Alternative method development will be further targeted to regulatory needs. There is also aneed to advance the promotion of the regulatory acceptance and application of alternative
methods.

94

EN

SEURAT-1 – a cluster funded via a joint venture between the European Commission (in theframework of FP7) and the European Cosmetics Association (COLIPA), each having awarded € 25
million.

43

ENPart I.
Operation of REACH

4.

Information in the supply chain

INFORMATION IN THE SUPPLY CHAIN
REACH promotes cooperation in the supply chain, at significant cost forcompanies however. For the moment it is too early to detect and assess theoverall benefits of these provisions.

Communication within the supply chain is a central cross-cutting theme of REACH.
In the previous legislation the focus was only on the communication from the supplierdown the supply chain. REACH has changed this fundamentally as downstream users(DUs) and distributors have to communicate up the supply chain. This two-way
communication aims at ensuring a more transparent and safer use of chemicals in theEU, leading to more innovation and benefits for health and environment.
Some elements for this new communication approach are well-known, some havebeen newly introduced:– Safety data sheets (SDSs) were already before REACH a well-accepted andeffective method to provide recipients with information on safe storage, handlingand disposal of substances and mixtures in the EU. With some adaptations they arealso an integral part of REACH. One of the major adaptations is the so-called“extended SDS” (eSDS), which is a SDS with relevant exposure scenarios from the
Chemical Safety Report (CSR) attached (Article 31).
– The new obligation to provide information for certain substances and mixtures,
which do not require a SDS (Article 32), a concept that was already applied
voluntary before REACH in some industrial sectors and has now been extended toall sectors covered by REACH.
– The new duty for all suppliers of articles to communicate information on
substances of very high concern (SVHCs) present in articles above a concentrationthreshold of 0.1 % weight by weight (Article 33) to any recipient, including
consumers, who so request.
– The new duty to communicate information on substances and mixtures, e.g. new
information about risk and hazard, up the supply chain, which provides theregistrant or the DU with a more comprehensive picture of the substances hesupplies and underlines the importance of cooperation between different actors in
the REACH framework (Article 34).
Safety data sheet and Article 32 information
REACH requires that a SDS has to be provided not only for all hazardous substancesand mixtures, but also for those substances identified as persistent, bioaccumulative
and toxic (PBT) or very persistent and very bioaccumulative (vPvB) and/or included
as SVHC on the candidate list. For other substances and mixtures, under specificconditions described in Article 32 only very basic safety information must be
provided. Although a particular format is not foreseen, in practice the general format
of a SDS is also used in these situations. In general, recipients accept this approach,but there is a concern that it may lead to misunderstandings for the recipients and

EN

44

EN

Part I.
Operation of REACH

Information in the supply chain

enforcement authorities. This has been clarified so far in the Guidance on safety data
sheets95, but should be further monitored.
In contrast to previous legislation, SDSs can now be provided equally in paper orelectronically, making IT-solutions, which are increasingly being applied bycompanies, easier to implement. Although the use of modern IT solutions is highly
recommended to streamline efficiently the communication requirements of REACH,
the practical implementation of electronic distribution systems is still a challenge.
In general, REACH improved the awareness on communication about substances andespecially on the role of the SDS. As a result of increased communication many
companies have integrated a chemicals management system into their structures forthe first time. A wide range of resources are generally needed to set up such systems.
It has been observed however that compared to bigger companies, in general, costs for
SMEs are proportionally higher96. The Commission services will continue its effort tosupport SMEs and invites ECHA to continue with the development of relevant tools.
The quality of the information provided has improved compared with the pre-REACH
situation. Further improvements in data quality can be expected as a result of the next
upcoming registration deadlines, when more data from newly submitted registration
dossiers will be available97, as well as of the adaptations from CLP and the revision ofAnnex II98, which will require certain important changes of newly supplied SDSs as
well as those already circulating.
On average, SDSs have doubled in length and are now 12 to 20 pages long. The
information has become more comprehensive and of better quality, especially forregistered substances. However, this has resulted in additional workload, as therelevant information has to be extracted. Many companies made the observation thatimportant information is being diluted in purely formal information99. The
Commission services invite ECHA to continue its work in this field.
Providing the SDS is a clear duty of the supplier. However, due to more complex
logistics of imports, specific difficulties were reported in the field of handling
mixtures, protecting confidential business information (CBI) and establishing efficientEN

95

Guidance on the compilation of safety data sheets, Version 1.1, European Chemicals Agency,
December 2011.

96

Study “Functioning of the European chemical market after the introduction of REACH”, CSES,
funded by the European Commission.

97

Study “The (nominal) risk caused by chemicals in 2012 compared to the 2007 baseline”, DHI andÖkoinstitut, funded by the European Commission, p. 1-4

98

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), OJ L 133, 31.5.2010, p. 1.

99

Study “Functioning of the European chemical market after the introduction of REACH”, CSES,
commissioned by the European Commission, p.90.

45

ENPart I.
Operation of REACH

Information in the supply chaincommunication between Only Representative and the DUs in his supply chain100. The
Commission services invite ECHA to continue its information work and industry todisseminate good practices.
The extended safety data sheet
The eSDS, a new communication tool, has not yet been widely used. According to thelegal obligation to update the SDS without delay, this has been expected however,since exposure scenarios are clearly new information, which may affect risk
management measures (Article 37(9)). The following reasons were reported:– The first registration deadline in 2010, which was very demanding for companies
per se and was the only source of the full required information, was given higher
priority in matter of time and other resources.
– Many existing IT-systems in companies were not fit for eSDSs and still needfundamental and resource-consuming adaptations. Due to the 2010 registration
deadline however, resources were concentrated on the registration.
– Supply chains can be very long and complex, so it can be assumed that in many ofthem the eSDS has not reached all recipients yet101.
Despite limited experience, early evidence points out that eSDSs are too complicatedand often too extensive. They are often 30 to 100 pages long and some of them areeven up to 1 000 pages. IT-systems could support necessary data handling and reduce
costs, but this would require the use of a harmonised format. ECHA, with the full
support of the Commission and in cooperation with industry, is already exploring
possible technical solutions and guidance, which should allow an efficient exchange
of information within supply chains.
The existing use descriptor system102 has proven to be useful for large companies, but
often too demanding for SMEs, who often need external support resulting in higher
costs. In this context, significant differences between suppliers of the same substanceand their use conditions were reported. This area requires better guidance, especiallytargeting SMEs and less experienced companies.
In contrast to substances, there is no clear obligation to elaborate and provide a
mixture-specific exposure scenario (ES). Several different approaches are being
applied for the time being. With the support of industry, ECHA has already started towork on a harmonised approach. This has to be finalised as a priority before the next

EN

100

Study “Impact of the REACH regulation on the innovativeness of EU chemical industry”, CSES,
commissioned by the European Commission; Study “Functioning of the European chemicalmarket after the introduction of REACH”, CSES, commissioned by the European Commission.

101

Study “Functioning of the European chemical market after the introduction of REACH”, CSES,
commissioned by the European Commission – Annex, p. 130.

102

Guidance on information requirements and chemical safety assessment, European Chemicals
Agency - Chapter R.12: Use descriptor system.

46

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Part I.
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Information in the supply chain

registration deadline and before companies have implemented their own internal
standards.
Language issues
SDSs contain highly specialised information often in a sector-specific jargon. This is
why translation costs can be relatively high with typical costs ranging from € 100 to €300 per SDS and language103, while costs for translating an eSDS are assumed to besignificantly higher due to their length. These costs certainly are justified, as it isnecessary for recipients to have understandable information on the chemicals supplied
to them. However, suppliers often refuse to supply the SDSs in the relevant official
language despite the clear legal obligation to do so. Further awareness-raising andstricter enforcement in this context is advisable.
Translations are often avoided due to liability concerns. For certain languages there islittle experience within the translating sector104. In this respect, a wide standardisationof information similar as in the case of the precautionary statements and hazard
statements of CLP could be considered. This would also help for the development of
future automatic translation systems for (e)SDS, which as of today provide
unsatisfactory results.
Substances in articles
Article 33 provides that suppliers of articles containing a substance included in thecandidate list in more than 0.1% weight by weight have to provide recipients of thearticle with sufficient information to allow safe use of the article. Consumers may also
request this information from suppliers of articles, in which case the information must
be provided, free of charge, within 45 days of receipt of the request. This provision
seems to be a challenge for industry. The following difficulties have been reported:– Six Member States and one EEA EFTA State disagree with the current
interpretation of the 0.1% threshold and requested ECHA to inform industry andother stakeholders about this divergence via the Guidance for articles. As a result,the objective of harmonisation of the internal market has been compromised, whichmakes communication on the presence of candidate list substances in articles evenmore complex and confusing for companies and enforcement authorities. The
Commission services stress the importance of a harmonised implementation andhave taken appropriate steps.
– Difficulties have been observed with regard to the lack of transitional periods after
a substance has been identified as SVHC and included in the candidate list. Once a
substance is on the candidate list, the information obligation applies immediately.

EN

103

Study “Functioning of the European chemical market after the introduction of REACH”, CSES,
commissioned by the European Commission, p. 45.

104

Study “Impact of the REACH regulation on the innovativeness of EU chemical industry”, CSES,
commissioned by the European Commission, p. 72; Study “Functioning of the European chemicalmarket after the introduction of REACH” , CSES, commissioned by the European Commission,
Annex, p. 132.

47

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Part I.
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Information in the supply chain

Although measures such as the introduction of ECHA’s Registry of Intentions andfixed dates for inclusion in the candidate list have already been implemented as asupport, this should be further monitored.
– Potential shortcomings in some Member States and/or sectors were reported in
respect to the requirement to inform consumers on SVHCs included in thecandidate list in articles on request. However, retailers and producers of articles
have already started to use SVHC-free articles as a marketing tool105. The means ofcommunication used seem to be highly varied. This area should be further
monitored.
To handle the massive information flow resulting from the information requirements
for substances in articles, companies and sector associations have developed (or aredeveloping) sophisticated tools. The most advanced sectors in this respect are theautomotive industry and plastics, followed by aerospace and defence106. The
Commission services urge other sectors to study those examples and explore possible
potential applications.
Costs and benefits of supply chain communication
Communication requirements in the supply chain were expected to add important
costs to the industry; however, they were also expected to bring a number of businessbenefits on which companies could capitalise.
E.g., it was envisaged that companies could build a greater customer confidence baseby referring to REACH, and although consumers are not (in general) aware about
REACH, some companies reported to use "REACH-compliance" as a marketing tooland claim that consumers have more confidence in their products.
With regard to these possible other "marketing advantages" no substantial benefits
from intensified communication in the supply chain have been observed yet. With
regard to risk management at company level, many companies pointed out that
REACH gave them more information about the substances they are using and led toan improvement of their risk management107.
These benefits in general are constrained by the complexity of setting up ad-hoc
systems in order to comply with REACH information requirements and related
administrative complexity and other considerations:– The longer and more complex a supply chain is, the more negative were theexperiences described by the industry. A very high degree of complexity wasreported in sectors such as pharmaceuticals, electronics, aerospace, defence and

EN

105

Study “Impact of the REACH regulation on the innovativeness of EU chemical industry”, CSES,
commissioned by the European Commission, p. 184.

106

Study “Functioning of the European chemical market after the introduction of REACH”, CSES,
commissioned by the European Commission - Annex, p. 130.

107

Ibid., p. 88.

48

EN

Part I.
Operation of REACH

Information in the supply chain

automotive108. As a result sectors had to invest in IT systems to support
communication activities with the reported cost between several thousands (forvery simple databases) up to € 16 million in some cases109. The automotive
industry with its IT-supported International Material Data System (IMDS) is themost advanced one.
– With more intensified communication, other concerns come to the forefront: EU
competition rules, protection of intellectual property and confidential businessinformation. Many companies who are in good faith complying with REACH may
have exposed themselves in these areas - this is especially true for smaller ones
which need more adequate training. Further guidance and training is highly
recommended.
– Non-EU suppliers consider certain information requirements under REACH as
breaching their confidentiality policies and often do not share this information even to their appointed only representatives (ORs). In some cases non-EUsuppliers have withdrawn from the EU market due to the demanding information
obligations110.
When seen in total, costs arising from communication requirements are seen as thesecond largest share in REACH compliance after registration costs. The costs for
SMEs seem to be relatively higher than for larger companies. Due to less knowledge
and expertise, those companies have to rely on external help regularly. A practicalexample of a company selling 10 substances in five Member States has shown that the
total costs for developing and translating SDSs can be in the range of € 3 000 to €5 000111.
At this stage the Commission services consider that numerous ways for costs
optimisations are still available. E.g., a significant part of the communication
activities was induced by unclear requirements for certain actors. Sometimes it
triggered intense flows of e-mails, letters, questionnaires and enquiries etc.112. The
recurring topics were SVHCs in articles (candidate list) and coverage of uses in theregistration dossier. Clarifications with regard to any remaining uncertainties would
result in lower communication fatigue.
Conclusions and recommendations
REACH has promoted cooperation in the supply chain. Companies have implemented
more sophisticated IT tools for communication and chemicals management thanks to
REACH. In addition, REACH has brought small companies to become part of an

EN

108

Ibid., Annex, p. 130.

109

Ibid.,, p. 45.

110

Ibid.,, p. 65.

111

Ibid., Annex, p. 114.

112

Ibid., p. 101 and Annex, p. 132.

49

EN

Part I.
Operation of REACH

Information in the supply chain

overall European chemicals management system. As a consequence, more than 60%
of companies involved have established dedicated structures (like units) and,
therefore, manage their chemicals in a more structured way than before. However, thishas increased costs for companies bearing a significant financial burden113.
The SDS remains the central communication instrument, but has been further
developed to become a more comprehensive source of data related to substances andmixtures. Due to the emerging complexity more harmonisation is needed on thecontent so that IT solutions can be more easily implemented. Furthermore there is aneed for more clarity on different aspects (e.g. translations, role of ORs, making
available in an electronic form, handling of mixtures, confidential businessinformation, competition law). The further development of the eSDS, which is now in
its phase-in stage, has to be followed closely.
Information requirements for SVHCs in articles are also a new challenge.
Furthermore communication in practical terms needs further support, while lessons
learned from different sectors are already available. The retail sector also needs to be
more actively involved in the implementation of Article 33.
Methodological assessment, communication and application of risk management
measures have been set into motion, but it is too early to detect and assess benefits at
a general level. This is the reason why, at the moment, the costs are overshadowing
the benefits. This can be expected to change with the next upcoming registration
deadlines.
Recommendations:4.1. Impact on costs of administration will be monitored and technical/legal support especially for
SMEs provided. The general effects concerning communication, cooperation in the supply chain
and the quality of information will also be monitored.
4.2. ECHA and MSCA should communicate and educate more about legal obligations of suppliers of(e)SDSs concerning language obligations.
4.3. Industry should focus on further knowledge-building within companies concerning REACH ingeneral and especially about issues such as confidential business information, EU competition
rules and protection of intellectual property.
4.4. ECHA should•

further promote (e)SDSs as the central risk management tool and inform companies on this
topic.

•

promoting better understanding of the role of OR, including by reviewing or developing new
guidance if neededand•

improve guidance and support on the Use Descriptor System in particular for SMEs.

4.5. ECHA together with the industry associations should continue developing REACH-related support
such as multilingual databases for SDS-phrases, harmonisation tools for eSDS format, databases
about uses of SVHCs and IT tools for the communication in the supply chain. Improve practicalusability and readability of (e)SDSs by cooperating with industry stakeholders. In particularmonitor development of eSDSs and ES for mixtures.

113

EN

Ibid., p. 39.

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Information in the supply chain

4.6. ECHA and MSCA should launch support activities to raise awareness on Article 33 in the retailsector and to improve the communication in this respect. In order to help small retailers incomplying with Article 33, list relevant non-confidential information on uses and sectors ofapplication for every substance on ECHA's dissemination webpage.
4.7. Action will be taken to ensure a harmonised interpretation of Articles 7 and 33

EN

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5.

Downstream users

DOWNSTREAM USERS
With REACH, downstream users have a new role in the supply chain which
requires a more active involvement in chemical legislation than in the past.
Overall, companies are positive that REACH will help to increase knowledge
about uses, but this is expected to mainly materialise after the next
registration deadlines.

As a novelty in chemical legislation, REACH made downstream users (DUs) a
distinct category of dutyholders and gave them an important role within its
framework. In this respect, it is important to note that in REACH the concept of use isvery wide, covering a very broad area of industrial operations and processes extending
far beyond the chemical industry.
Through rights and obligations introduced by REACH, DUs became active players
and a central source of information on different aspects concerning the uses ofsubstances. They are companies spread through a wide range of sectors (e.g.
aeronautics, electronics, formulators) and can be very different types of businesses(e.g. internationally or EU-wide active industry, SME, family business). They may
have varied levels of awareness of chemical legislation and different chemicals
management structures, and due to the wide definition of a DU, they might not always
be aware of REACH provisions. For these reasons, it is important to bear in mind that
there is no "typical" DU.
DUs have obligations and rights stemming from many REACH titles: registration,
evaluation, authorisation, restriction, communication in the supply chain. Theseelements are discussed in the corresponding titles in more detail. The discussion inthis title will mainly concentrate on Title V of REACH concerning downstream users.
Role of downstream users
Before REACH registration, knowledge of uses of substances and mixtures on the EU
market was limited and the level of detail was varied between sectors. As described in[Title 2], the registration process requires, i.a., an inclusion of information on
identified uses, relevant exposure and risk management measures. This information
allows DUs to ensure safe use of the substances and mixtures. However, as parts ofrelevant information might not be available to the manufacturer or importer, the DUs'
role in the registration process can therefore be to support the gathering of all thenecessary information. DUs and distributors may provide information to assist in the
preparation of a registration and have the right to make a use known to suppliers(Article 37).
In addition, DUs often have new information about different uses and ways of
exposure. They are also the ones who apply the risk management measurescommunicated by the suppliers through the safety data sheet (SDS) or other relevant
information according to Article 32. Their practical experience with the substances
can provide valuable information up the supply chain, especially about new hazardous
properties, the appropriateness of risk management measures and new uses.
One of the main instruments to support DU are national helpdesks established on thebasis of Article 124 of REACH in every Member State. They are coordinated by

EN

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ECHA in an EU-wide network called HelpNet, with the aim to exchanging
information and to giving fast, harmonised answers. Some of these answers are
eventually published on the ECHA website FAQ.
Uses of substances
One of the most important obligations of DUs is set out in Article 37(5). This
provision requires a DU to identify, apply and, where suitable, recommend
appropriate measures to adequately control risks identified in SDSs supplied to him,
in his own chemical safety assessment (CSA) and/or in any other relevant information
on risk management measures supplied to him in accordance with Article 32.
Usually it is the task of the registrant of the substance to carry out a CSA, todocument it in the chemical safety report (CSR) and to reflect it in relevant exposure
scenarios annexed to the SDS (eSDS). However, a DU shall prepare for his substance,
on its own or in a mixture, an own CSR for any use outside the conditions describedby the supplier or for any use his supplier advises against; alternatively he can report
information on a new use up the supply chain in order for it to be assessed against
risks for health and environment.
Chemical safety report
Once a DU decides to carry out a CSA, he has to consider a number of aspects. The
requirements are usually not as challenging as for a full registration, but also theexpertise of a DU company might not usually be as high as that of a registrant. The
same applies for experience in regulatory matters.
If a DU decides to perform his own CSR, he must report certain information to ECHA
within six month after receiving a registration number in a SDS. The CSR itself has tobe performed within 12 month after receiving a registration number in a SDS.
At the time of publishing this paper only a few notifications by DUs performing theirown CSR were submitted to ECHA. One major reason might be that DUs have up to
six months to comply with the reporting obligations after receiving the eSDS.
Therefore it is still rather early to provide a detailed view on this topic. One has totake into consideration that until now, it is mainly substances in volumes of 1 000
tonnes or more per year that had to be registered. For these substances the knowledge
gaps are relatively small and the suppliers have more or less an exhaustive view on
the uses. However, this can be expected to change when lower quantity substances
will be registered. For these substances the costs related to CSR obligations can besignificant for DUs, in particular for SMEs. Depending on the individual case, costs
are normally not more than € 25 000, but there are exceptional cases with costs up to€ 50 000114. These costs were estimated before the adoption of REACH at an averageof € 8 963 and a maximum theoretical cost of € 35 850115, which is noticeably lower
than reported now and should be further monitored.

EN

114

Ibid., Annex, p. 122.

115

Study “Assessment of the Business Impacts of New Regulations in the Chemicals Sector”, RPA,
commissioned by the European Commission, June 2003, p. 67.

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Fees are not foreseen in this context, so all major costs can be directly attributed to thecost for human resources, data collection and the actual drawing up of CSRs. Anotherfactor is the cost of external consultants, especially for SMEs. The mechanism ofdrawing up a CSR is nevertheless only applicable for substances registered according
to Article 6 and not as intermediates. Once a substance is registered as an intermediate
only, it cannot be used in a different way. An extension to non-intermediate uses isonly possible, when the registrant agrees to make a registration according to Article 6.
This however can be connected to more data requirements and higher fees. In thisrespect a better and more transparent communication in the supply chain will be
important for the upcoming registration deadlines, to prevent a DU from using asubstance in a different way. This has been reported in discussions in the Directors’
Contact Group discussed in [Title 3].
There are also concerns that registrants are carrying out exposure modelling using
default assumptions only and that this is resulting in some cases to unrealistic
recommendations on operating conditions and risk management measures fordownstream users116.
Registration deadline 2010
ECHA published a list of all pre-registered substances at the end of 2008. One of theaims of the list was to give DUs a possibility to gain an overview whether theirsubstances will be registered. Due to the fact that all EINECS substances were preregistered, the list was only of limited use. As a consequence, before the firstregistration deadline in 2010 the Commission together with ECHA and industry took
steps to gain an overview of all substances which would be registered for that
deadline. Especially DUs needed this information about the future availability of theirsubstances for further planning. This screening was performed within the context of
the DCG and proved to be very useful in terms of transparency and further planningfor DUs.
Until now there is no indication that relevant substances have been withdrawn fromthe market because of REACH. Certain changes in portfolios and suppliers have beenreported as usual business. Nevertheless, in some cases REACH has facilitated an
ongoing phase-out117.
It has been also observed that some DUs are willing to contribute to the registration
costs for a substance that is critical to them. This is done in different ways, e.g.
through direct contributions to the costs of a registration dossier or by agreeing on
guaranteed purchasing periods or quantities118. Withdrawal of substances could
become more relevant for later registration deadlines, making the monitoring work as

EN

116

Study "Assessment of the health and environmental benefits of REACH", RPA, commissioned by
the European Commission, April 2012.

117

Study “Functioning of the European chemical market after the introduction of REACH”, CSES,
commissioned by the European Commission, March 2012, p. 60.

118

Ibid., p. 60.

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performed in the DCG even more relevant, which is also a reason why organisations
representing DUs from different stages in the supply chain (e.g. formulators andproducers of articles) have joined this group. In general more transparency byregistrants concerning their registration strategies would help DUs in further planningtheir next steps. The Commission services will continue to monitor progress in thisarea.
Current situation and observations
In general companies are positive that REACH will provide more knowledge about
uses, but this can be expected to a larger extent after the next registration deadlines. In
addition, studies show that DUs request their suppliers to avoid SVHCs and otherhazardous substances, which could be a potential for innovation. Human resources
had to be drawn away from manufacturing and R&D to ensure REACHcompliance119. Innovation and business opportunities have not been reported yet, but
might materialise at a later stage.
The situation regarding information on risks and hazards seems to have slightly
improved already after the first registration deadline120. However, also here
companies expect to gain more information after the next registration deadlines. The
same is valid for information on risk management measures, where more details andquality are already being observed. One of the major benefits in this regard is thegrowing awareness about the necessity of proper chemicals management in generaland the role of SDSs as the central communication tool on risk management measures
as discussed in the [Title 4] in more detail.
Downstream users producing articles
Producers of articles can be subject to new obligations introduced by REACH. One ofthese obligations relates to SVHCs included in the candidate list according to Article
59. This can have impacts, e.g. the need to communicate information according to
Article 33, which are highly relevant to those DUs who produce and supply articles.
The impact on producers of articles varies strongly between sectors. Some sectors are
already familiar with similar communication, such as under the RoHS Directive121,
where it is common to inform customers on a voluntary basis about the absence of
certain substances in articles. Other sectors are only now confronted with suchrequirements. However, not only communication requirements have an impact. The
impact of providing information on the content of SVHC sometimes stretches far

EN

119

Ibid., p. 98.

120

Ibid., p. 88; Study “Assessment of health and environmental benefits of REACH”, RPA, p. 13;
Study “The (nominal) risk caused by chemicals in 2012 compared to the 2007 baseline”, DHI andÖkoinstitut, p. 1-4.

121

Directive 2002/95/EC of the European Parliament and of the Council of 27 January 2003 on the
restriction of the use of certain hazardous substances in electrical and electronic equipment, OJ L
37, 13.2.2003, p. 19.

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Downstream users

beyond the legal requirements of REACH. E.g., some customers refuse to buy articles
containing SVHCs.
As described in more detail in [Title 7], the candidate list or even other, informal lists(e.g. SIN-list122) seem to work in certain cases as a blacklist, with the effect that
customers are preferring articles free of SVHCs123. For the DU producing articles, this
implies finding a substitute for the critical substance(s). Moreover, when using
substances already included in Annex XIV (i.e. requiring an authorisation), EU
producers are at disadvantage compared to the non-EU producers of articles, who are
not bound by the authorisation requirement of REACH and often might be subject toless stringent requirement under their national (non-EU) legislation. This effect has
been acknowledged, but so far it was not observed in practice, also because theauthorisation obligations will become fully functional at a later stage.
Problems have been reported by the industry in the process of identifying SVHCs andlisting them in the candidate list. The process was claimed to be too quick andunpredictable, to cause problems with developing substitution plans on time and to
demand constant monitoring. These issues have been already taken up and thecandidate list is now regularly updated at fixed dates twice a year.
There have been many cases of companies who stated having greater confidence inEU products thanks to the requirements of REACH.
Conclusions
DUs may have varied levels of awareness of chemicals legislation and different
chemicals management structures. It has also been reported that some affectedcompanies might not have knowledge of REACH provisions at all, which is a nonsurprising consequence of the wide definition of DUs.
Although REACH has led to additional administrative work in order to comply with
its requirements, in general DUs are taking responsibility towards REACH
compliance. An important contribution comes e.g. from industry associations andchambers of industry and commerce, where the support is given through a wide
variety of tools, starting from general information similar to information obtained
from national helpdesks to very sector-specific support, which is often going far
beyond what authorities can offer. The Commission services invite industry
stakeholders to continue developing tools designed to help DUs.
The guidance provided so far by ECHA is perceived as sufficient, especially after the
improvement of translation activities by ECHA. The issue of DU-CSA will become
more relevant in the near future and it should be monitored to which extent theexisting guidance is sufficient. The Commission services invite ECHA to further
develop its DU-targeted tools (e.g. ENES, CHESAR and the tools for SDSs).

EN

122

"Substitute It Now", a list published by Swedish NGO ChemSec.

123

Study “Functioning of the European chemical market after the introduction of REACH”, CSES,
commissioned by the European Commission, March 2012, p. 66 and 101.

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Downstream users

Awareness and knowledge on REACH among smaller DU companies is sometimes
very low or even non-existent. This is a matter of concern and should be monitored.
Existing channels such as the DCG, the Europe Enterprise Network, industry
stakeholders (e.g. UEAPME, CEFIC, DUCC and other sectoral organisations),
national helpdesks or HelpNet are useful tools for this task and should be used by theCommission and ECHA, as they have been in the past on different occasions.
Recommendations
5.1. ECHA and Member States are invited to support further awareness-raising and knowledgebuilding within DU companies. Member State helpdesks and Competent Authorities (CAs) areinvited, based on lessons learned from industry examples, to provide sector-specific support. DU
organisations and other existing networks in relevant discussions, notably at the level of the DCG
will continue to be involved; this is especially relevant for the upcoming registration deadlines in2013 and 2018.
5.2. Impacts on competitiveness, including on producers of articles will be monitored.
5.3. Impacts on innovation, especially in respect to possible diversion of resources from R&D to legal
compliance, including the resources needed for the development of DU-CSR (Annex XII) willcontinue to be monitored.
5.4. Industry is invited to promote more transparency within the supply chain, especially about
registration plans for specific substances and their uses.
5.5. Industry is invited to further raise awareness on SDSs and eSDSs being central risk management
tools with a view to disseminate good practices within supply chains.

EN

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6.

Evaluation

EVALUATION
Dossier evaluation is a critical step for ensuring credibility of the registration
process and is serving to improve the quality of the registrations dossiers.
However, much more was expected with regard of the commitment of Member
States to the substance evaluation.

E in REACH stands for Evaluation. As the safe use of substances under REACH
starts with compliant high quality registration dossiers that are industry’s
responsibility, REACH provides for the follow-up to the registration by the possibility
to evaluate these dossiers, assess their compliance and request additional informationor order further tests when essential data is required.
Title VI of REACH describes three types of evaluation under REACH: dossier
evaluation, comprising compliance check and the examination of testing proposals(Chapter 1: Articles 40 to 43), substance evaluation (Chapter 2: Articles 44 to 48) andthe evaluation of intermediates (Chapter 3: Article 49). In Chapter 4: Articles 50 to
54, the common provisions for functioning of evaluations, the adoption of evaluation
decisions and the publication of information on evaluation are laid down.
In examination of testing proposals, ECHA examines all testing proposals submitted
by the registrants for provision of the information set out in Annex IX or X. In
compliance check, ECHA determines whether or not the information submitted in theselected subset of registration dossiers is in compliance with REACH.
There may be grounds for concern that a specific substance represents a risk forhuman health or the environment but the concern still needs to be clarified before
action such as the authorisation or restriction procedure, if required, is considered.
ECHA can then in cooperation with the Member States take the necessary steps for a
substance to be placed in the Community Rolling Action Plan (CoRAP) and evaluatedunder substance evaluation.
The general REACH provisions for dossier and substance evaluation do not apply to
on-site isolated intermediates. However, where the Competent Authority (CA) of thesite’s location has concern regarding serious risk to human health or the environmentthat is not being properly controlled, the CA can require the registrant to provide itwith the information needed to assess this concern. Following its evaluation, the CA
with concerns must inform ECHA which then informs other CAs and communicatesthe results.
In terms of responsibility for the process, dossiers subjected to dossier evaluation areevaluated by ECHA. In substance evaluation, the evaluation is performed by the CA
that has been designated to perform the evaluation in the CoRAP. In both cases the
prepared draft decision may be commented by the registrant(s) and the CAs; the latter
may propose amendments to the decision. These are discussed in ECHA Member
State Committee (MSC) referred to in [Title 10]. When the MSC members agree by
consensus, the final decision can be adopted by ECHA, otherwise the matter isreferred to the Commission. All evaluation procedures run under strict deadlines thatimportantly determine the organisation and workload of ECHA, MSC as well as CAs.

EN

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Evaluation

Examination of testing proposals ensures that the higher tier testing, including testingon vertebrate animals, addresses true information needs of REACH and that tests are
not performed when the information is already available or in preparation, addressing
prevention of unnecessary animal testing.
Identifying non-compliance in the evaluated dossiers and requiring action byindividual registrants through legally binding decisions addresses the deficiency of
those evaluated dossiers and enables enforcement, but also more widely promotes
compliance and the respective quality of dossiers by all registrants. Substanceevaluation also enables the requirement of information that is not part of the REACH
standard information requirements, addressing any substance-specific potential
limitation in ensuring the provision of an adequate basis for risk assessment.
Evaluation is also often the first mechanism within REACH where an implementation
issue or the scientific and technical process is identified that may trigger improvementof particular guidance or other activity. Through these features evaluation facilitates alevel-playing field implementation of REACH and is an important enhancer of humanhealth and environmental benefits.
Dossier evaluation
The requirement to perform compliance check on at least 5% of registration dossiersin each tonnage band and ECHA own targets lead to ca. 1 000 dossiers submitted by
the first registration deadline to be checked for compliance by the end of 2013, withup to 600 further dossiers annually thereafter for an unspecified length of time. In
2011 only, 158 evaluations were initiated and 146 completed under compliancecheck124. Dossiers to be evaluated are selected by ECHA on the basis of prioritisation
criteria outlined in Article 41(5), as well as on the basis of search algorithms that
introduce a degree of randomness to substance selection and also allow setting the
focus upon specific areas of concern that may be identified.
In its annual reporting under Article 54124, ECHA derives some statistics of theevaluation process. The 146 completed compliance checks in 2011 concluded in 105
final decisions and 19 quality observation letters (QOBLs)125, with 22 closed without
administrative action before or sometimes even after the draft decision was issued.
The very high proportion of final decisions within the total number of dossiers
evaluated is due to the large number of targeted compliance checks on substanceidentity that were triggered by concern identified during examinations of testing
proposals. For the randomly selected dossiers and the dossiers selected throughconcern-driven selection, the percentage resulting in final decision was lower (41%
and 52%, respectively). Final decisions in general addressed more than one
information item to bring the registration into compliance. Main information items
requested were on substance identity (Annex VI, Section 2), mutagenicity (Annex
VIII, point 8.7.1), prenatal developmental toxicity (Annex IX, point 8.7.2) andpredicted no-effect concentration as part of the environmental hazard assessment

EN

124

Evaluation under REACH, Progress Report 2011, European Chemicals Agency, 2011.

125

In certain cases ECHA sends a letter to the registrant that includes observation on the identified
deficiencies in the dossier that had however not been included in the decision.

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Evaluation(Annex I, point 1.4.1). Main identified shortcomings addressed in the QOBLs126
include classification and labelling, CSR-related PNEC or DNEL derivation, andsubstance identity.
The Commission services note that, while the representativeness of the sample to dateas to the compliance status of dossiers in general is still limited, the initial analysis ofdecisions identifies principal compliance shortcomings with respect to substanceidentity, justification for data waiving and the level of detail within robust study
summaries. These identified areas of concern were to an important extent anticipated
due to the scope and newness of registration requirements.
As regards the examinations of testing proposals, 80 out of 587 examinations in 2011were closed or resulted in a final decision, with a further 144 at the draft decision
stage. The vast majority (92%) of the examinations addresses the testing proposals forphase-in substances. Roughly three-quarters of all examinations of testing proposals
also include third party consultation as they cover testing on vertebrate animals, andin 2011 ECHA received 481 comments from non-governmental organisations,companies, industry or trade organisations and individuals. The majority (13) of the
22 final decisions in 2011 cover the non-phase-in substances for which the deadline
for the examination of testing proposals is six months, while the proposals for phasein substances submitted within the first registration deadline need to be evaluated by 1
December 2012.
Dossier evaluation procedures by all involved actors, and in particular ECHA, are by
now well-established and are generating decisions at an accelerated rate. Scrutiny of
ECHA work by MSCA is apparent through the fact that, e.g., 11 out of the 22 final
decisions adopted in 2011 received at least one proposal for amendment by a CA,
triggering discussion in the MSC before adoption, see [Title 10]. To date however,
the only issue that has not been resolved unanimously within MSC and for which
therefore the related decisions127 have been passed to the Commission, is on the study
protocol to be used for addressing the information requirement of Annexes IX and X,
point 8.7.3. "Two generation reproductive toxicity study". Some members were infavour of requesting the OECD TG 443 "EOGRTS" study, whilst others could notagree on imposing the use of the new guideline (also in light of the existing EU
method B.35) or could only accept its use within certain specifications. The
Commission has until now not concluded its deliberation in these cases, so the dossier
evaluation process in this last variation has not yet been tested in full.
Registrants are kept informed about the dossier evaluation process, their rights, their
obligations and the possibilities to interact with ECHA at several points in theprocedure. When issues are referred to the MSC, representatives of the registrants,
and when agreed by the registrant also the stakeholder observers are offered apossibility to be present at the session where their case is addressed, see [Title 10].

EN

126

Quality Observation Letters – for definition and further assessment see concluding paragraphs ofthis chapter.

127

Four by February 2012.

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Evaluation

Nevertheless, it has been reported that registrants often find the procedures complex
and may misinterpret the objective or steps in the exercise.
As regards the final decisions, only two had been appealed as of 15 April 2012 by theregistrants. Both appeals are still pending.
To date no testing proposal has been rejected on the basis of the third party
information.
Dossier evaluation has until now processed all dossiers within the prescribeddeadlines. To ensure that the remaining almost 700 compliance checks to be carriedout by the end of 2013 and that all examinations of testing proposals are processed intime, dossier evaluation has significantly raised its throughput in 2012, and thepotential impact of this additional strain on the process is not yet apparent. Increase inefficiency is clearly required. It is pursued through repeated re-examination of theprocess within MSC. Efficiency has also been the principal focus of the January 2012
2nd Workshop on Dossier Evaluation.
Dossier evaluation will either result in decision or be concluded without any
administrative action when a decision is not required or cannot be made at therelevant point in time. An additional tool used in the evaluation context are the
QOBLs in which ECHA invites registrants to revise their registration dossiers andaddress shortcoming not related to formal data gaps. The incentive of these letters is
to inform registrants and CAs on quality issues in registration dossiers that raise
concern. The letters are sent alongside evaluation decisions or may, in compliancecheck cases, be the only communicated result.
As the QOBLs require additional administrative effort but are not legally required nor
contain legally binding obligations, their added value has been questioned. The initialassessment shows fair response by the addressed registrants, with appreciation of theprovided information by the CAs and enforcement authorities. Bearing in mind thatthe analysis work leading to the drafting of a QOBL is in any event carried out as partof the evaluation process, the Commission services believe that QOBLs provide real
added value at little additional work.
The Commission closely monitors the overall impact of the implementation of dossier
evaluation on compliance and on the quality of registration dossiers, as this impact isa direct consequence of the application of Article 41(5) (including the >5%requirement) that can be modified in accordance with Article 133(4). At present, norobust conclusions can be drawn due to the still limited number of evaluations and therelatively short time of implementation.
Progress in the compliance check strategy in terms of selection of dossiers andtargeting of their evaluation to specific areas of concern, where automated tools canbe exploited, can also contribute to the increase in efficiency and the achievement ofgoals of dossier evaluation. Innovative approaches had already been discussed
between ECHA, CAs and the Commission and are now being further developed by
ECHA.

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Evaluation

Substance evaluation
In February 2012, the first substance evaluations were launched, following the
adoption of the first CoRAP covering a period of three years and published on the
ECHA website128. The CoRAP will be revised annually.
Exacerbated by the initial uncertainty in the exercise and the eventual intensity ofresources required, Member States have been reluctant to pledge their commitment
for a significant number of substances for any of the first three years. 36 substances
are being evaluated in 2012 by 17 Member States, with 90 substances assigned for thethree-year period. This is significantly lower number than the initial expectation of
250 substances (ca. 50 in 2012 and 100 substances annually thereafter). In somecases, two CAs have agreed to evaluate a substance together, with one CA in the lead.
CAs now have 12 months after the publication to evaluate the substance and prepare a
draft decision. The substance evaluation provisions of REACH have thus not yet been
fully implemented. In contrast to the compliance check, where a single dossier isbeing evaluated, the CA under substance evaluation evaluates all dossiers in which thesubstance is covered, and the decision may include, stating reasons, information
requirements that go beyond standard information requirements of Annexes VII to X
to REACH. There are practical implementation aspects that were already discussed inseveral workshops.
Following evaluation, CAs are required to inform ECHA of whether and how theresults of the evaluation should be used, information that ECHA must then pass on to
the registrant, the Commission and other CAs.
During the preparation of the CoRAP, stakeholders had indicated lack of transparency
in the identification process of candidates for the CoRAP list. There has even beensome misunderstanding that substances put on CoRAP are somehow 'blacklisted',though placing on CoRAP should have no impact per se on the substances as theoutcome of the evaluation may be a confirmation or the refutation of a risk.
With the first CoRAP, ECHA also provides very limited information on thejustification for the selection of substances, as the prepared CA justification
documents have not been sufficiently assessed for sensitive information and therefore
have to remain confidential.
Experience with the preparation of the 2012 CoRAP indicates that improvements areneeded in the selection process, in the access of IT tools by Member States and in thegeneral coordination between ECHA and CAs.
Evaluation of intermediates
Supporting CAs, ECHA has in 2011, on the basis of its initial screening of dossiers on
intermediates conducted in 2010, undertaken a new verification of intermediate status.

128

EN

Document "Community Rolling Action Plan (CoRAP)", 29 February 2012 [available onwww.echa.europa.eu]

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Evaluation

A manual screening of approximately 400 selected dossiers of on-site and transported
isolated intermediates identified several cases where the information contained withina dossier is insufficient to check if reduced registration for isolated on-site ortransported intermediates was justified according to Article 17 or Article 18,
respectively. By the end of 2011, 40 letters related to 17 substances were sent to theregistrants, requesting further information in accordance with Article 36. Further
action by ECHA may follow as the responses to the letters sent in accordance with
Article 36 are assessed in 2012.
Conclusions and recommendations
The Commission services note that dossier evaluation is on track, but acknowledges
important challenges ahead. While it is as yet not possible to identify its positive
impacts (e.g. downwards trend in the proportion of non-compliance in the evaluateddossiers), decisions as the principal output of the process are being produced at anaccelerated pace and with scientifically and legally sound argumentation. The main
challenge ahead is to ensure continuous quality of output while having a much higher
throughput that is required already at present but also in the foreseeable future.
The Commission services therefore support recommendations that have been brought
forward in ECHA Workshop on Dossier and Substance Evaluation 31 Jan - 1 Feb
2012 to increase the efficiency of the process by:– optimising all underlying technical support such as IT tools, to minimise
administrative burden;– even better interaction between main actors (ECHA, MSC and CAs), in particularin proactively addressing generic issues (e.g. application of new test method) andfeedback to CAs on discussions in MSC and the rationale behind the decisions,
resulting in streamlined commenting and proposals for amendments;– optimisation of dossier selection and targeted compliance check, limiting in cases
the number of endpoints addressed and focusing on few identified areas ofconcern, enabling a large number of non-compliant dossiers to be addressed bylegally binding decisions thus maximising the regulatory impact.
Some of these recommendations are already being put into practice by ECHA. The
Commission services will continue to monitor the overall impact of theimplementation of dossier evaluation on compliance and the quality of registration
dossiers and may in future propose modification of Article 41(5) if appropriate.
Follow-up to the dossier evaluation decisions is an emerging issue, as for example 42
updates of dossiers following targeted substance identity check decisions have been
received and the follow-up procedure initiated by ECHA. There are already situations
where the update has not yet been received, although the deadline has expired.
While it is too early to conclude about substance evaluation, it is clear that the numberof substances committed to date by Member States is below the initial expectation.
The Commission services also note that further work on transparency of theevaluation process is required, between the registrants but also with stakeholders and

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general public, probably not as much by modifying the process as by stepping up
communication and awareness-raising.
Recommendations
6.1 An assessment by ECHA and CAs of the benefits and resource implications of using QOBL within
2 years is recommended. ECHA is encouraged to continue using QOBL where effective.
6.2. ECHA is invited to re-examine and streamline the third-party consultation process, for example
through standardised replies and further guidance to focus these contributions to further increase
efficiency of the dossier evaluation.
6.3. ECHA is invited to pay specific attention to the follow-up to the evaluation decisions; taking into
account resource implications and coordination with Member State enforcement actions.
6.4. CAs are encouraged to enhance their capacity in relation to substance evaluation. ECHA is also
invited to enlarge the number of substances to be considered for inclusion in the CoRAP andprovide support to CAs performing substance evaluation.
6.5. ECHA is invited to make future substance evaluation justification documents public while
respecting the requirements of Articles 118 and 119 of REACH.

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7.

Authorisation

AUTHORISATION
The authorisation process is not yet fully operational, but important progresshas been made in the preparation of Annex XV dossiers for substance of very
high concern (SVHC) identification, in populating the candidate list and inincluding substances in Annex XIV. Efforts should continue to possibly
intensify the SVHC identification process.

Selection of substances for the candidate list and Annex XV dossiers
The first step of the authorisation process is the preparation of a so-called "Annex XV
dossier" for SVHC identification by a Member State or ECHA (the latter on behalf of
the Commission).
SVHCs are substances whose intrinsic properties meet one of the following criteria
set out in Article 57:– the criteria for classification as carcinogenic, mutagenic or toxic for reproduction(CMR) category 1A or 1B in accordance with Annex VI to CLP;
– Substances that are persistent, bioaccumulative and toxic (PBT) or very persistentand very bioaccumulative (vPvB) in accordance with the criteria of Annex XIII;– Substances that give rise to an equivalent level of concern to substances of theprevious categories on the basis of scientific evidence of probable serious effects tohuman health or the environment.
Until now, most Annex XV dossiers include CMRs and mono-constituent substances.
In fact, the identification of a substance as SVHC is straightforward in case of monoconstituent CMR substances included in Annex VI to CLP. However, Annex XV
dossiers are more complicated for substances with several constituents and substancesof unknown or variable composition or biological origin (UVCBs) because ofcomplex substance identity, for PBTs and vPvBs because of the absence of aclassification according to CLP, and for substances of equivalent concern according to
Article 57(f), which need to be identified on a case-by-case basis.
By 1 June 2012 the candidate list contained:– 67 CMRs identified according to Article 57(a), (b) and (c);– four PBTs identified according to Article 57(d);– one vPvB identified according to Article 57(e);– one substance of equivalent concern identified according to Article 57(f) (as an
endocrine disruptor), added in December 2011.
As far as PBTs and vPvBs are concerned, ECHA established an ad-hoc groupcomposed of Member States, ECHA and Commission experts at the end of 2011 withthe view to cover detailed scientific questions and issues related to PBT identificationand therefore facilitate their identification.

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The procedure foreseen in Article 59 for SVHC identification proved to work in an
efficient way for the seven identification exercises conducted from October 2008 to
December 2011. During that period the members of the Member State Committee(MSC) were always able to get unanimous agreement on the identification of thesubstances and the Commission was not asked to prepare a proposal for SVHC
identification according to Article 59(9).
As indicated above, REACH foresees a multiple right of initiative in the process of
SVHCs identification: any Member State or ECHA (the latter on behalf of theCommission) may submit an Annex XV dossier and no platform for priorcoordination is foreseen. This novelty, together with the introduction of theauthorisation process as an addition to the pre-existing restriction process, made clear
to ECHA, Commission and Competent Authorities (CAs) a need to identify at an
early stage which initiatives were taken by which authorities and whether
authorisation and/or restriction are an appropriate way to address the potential risk
posed by substance, as further explained in [Title 7 and 8]. A workshop organised by
ECHA in January 2009129 recognised the need for close coordination among thedifferent actors, in order to apply a coherent approach and to use resources in an
efficient way. At the same workshop, a risk management option (RMO) process was
put in place with the full support of Member States, ECHA and the Commission toreach two main objectives:– Discuss the different regulatory options and their effectiveness as far as possible
before proposing a substance for SVHC identification;– Coordinate the activities of all the actors in charge of the process.
From 2008 onwards, possible candidates for SVHCs have been screened looking
mostly at substances classified as CMR category 1A and 1B. The identification
exercises will be more and more based on new information (from 2013-2018,
registration dossier and evaluation activities) and on new approaches (application of
Article 57(f) to substances of equivalent concern and of the amended Annex XIII for
PBTs and vPvBs). Information submitted by registrants in the CSR is critical for thisexercise. The RMO process now sets the framework to agree on a common andcoordinated approach to the future selection of SVHCs.
The Commission services strongly support to continue working in a common
framework for the screening of SVHCs in a coordinated way, especially for theidentification of substances of equivalent concern. The Commission services believethat identification of SVHCs according to Article 57(f) should take place by preparing
Annex XV dossiers for specific cases, and, in parallel, by developing guiding criteria.
The Commission services believe that, in the process of Annex XV preparation,
attention should be dedicated to those substances for which the identification as

129

EN

See document "Workshop on the Candidate List and Authorisation as Risk Management
Instruments, Workshop proceedings" Helsinki, 21-22 January 2009, [available onwww.echa.europa.eu]

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SVHC is not straightforward (complex substances, PBTs, vPvBs and substances of
equivalent concern). A common understanding should be developed to define theinformation needed for substance identification in order to be able to implement all
steps of the authorisation process.
Looking at the activities in the medium term, the Commission services would supporta roadmap in the framework of the RMO process, to achieve the objective to include
all relevant, currently known SVHCs in the candidate list by 2020. The milestones
should include:– Complete the screening of the classified CMRs to identify the relevant ones for the
candidate list;– Build experience and develop criteria to identify the substances of equivalentconcern and include the relevant ones in the candidate list;– Use the data from 2013 and 2018 registration dossiers and the results of evaluation
activities to select relevant SVHCs not identified with the previous screening
activities.
The candidate list
Once the MSC has agreed on the identification of a substance as a SVHC, ECHA
places it on the candidate list, which is published on its website.
It has been agreed by the Member States, ECHA and the Commission to launch the
Article 59 procedure twice a year, in fixed periods. As a consequence, the candidate
list is also updated twice a year, normally in June and December.
A process for removing substances from the candidate list (e.g. in case of amendmentof a classification) is not specifically foreseen in REACH.
The number of substances on the candidate list has been increasing continuously from2008 onwards. It is clear that the actors involved gradually gained more experience
with the process and the discussions in the RMO framework helped to arrive at the
SVHC identification phase with dossiers containing all available information. The rate
at which substances are being added to the list is increasing. E.g. in December 2011,20 entries (the largest increase since the process started) took the number ofsubstances on the candidate list to 73.
It is worthwhile to recall the Commission's aim to have 136 substances on thecandidate list by the end of 2012 and to have all relevant, currently known SVHCs on
the candidate list by 2020. This objective has had the merit of stimulating an increased
activity of Member States in relation with the submission of proposals for SVHC
identification. The candidate list currently contains 84 substances and 54 substances
are being considered for inclusion by the end 2012 bringing the total number ofsubstances up to 138, corresponding to or even exceeding the political commitment.
The Commission services will continue to encourage Member States to contribute
more actively to the process of SVHC identification. ECHA and the Commission

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services will continue to contribute by providing assistance, coordination and sharing
experiences with the Member States.
Quantitative information on the effects of the candidate list is still scarce, possibly
because the process, although started in 2008, has seen a significant increase in thenumber of substances in the candidate list – including substances with high tonnages
and many uses - only from 2010 on.
To date, few cases of a "blacklist effect" of the candidate list were reported130 but theperception of many downstream users (DUs) is that, as soon as a substance is includedin the candidate list, it will be banned from the market in the near future and it has tobe substituted in processes and, as a consequence, in articles. Some examples havebeen reported of governmental public procurement which in the selection criteria
excludes articles containing substances on the candidate list. This may be due to alack of clear information and communication to the parties concerned about the
obligations and the effects of the candidate list. In this context, the Commission and
ECHA are considering possible information activities to facilitate the understandingof the candidate list and of the authorisation process in general among all actors,
including DUs and consumers, and would encourage Member States to do the same.
The candidate list has also been reported as one of the instruments of REACH that
could drive innovation, thanks to substitution of SVHCs with safer substances. It isreported131 that the placing on the candidate list can lead, in some cases, to the launchof initiatives to develop new substances or to the reformulation of existing substances.
However, the same study reports also that the substitution of substances that are welltested and well adapted to the process, with substances for which less information isavailable and which might not have been tested for the specific process, may be achallenge for the companies involved.
The candidate list is not only the first step in the authorisation process. It also triggers
obligations for article producers and importers to notify to ECHA, and for suppliers ofarticles to inform recipients on the presence of SVHCs in the articles, following theprovisions of Articles 7(2) and 33 of REACH. These requirements might not be easy
to meet, especially for complex articles (see [Title 4] for more details).
As stated in Article 59 of REACH, the candidate list is established for eventual
inclusion of SVHCs in Annex XIV. According to the requirements of Articles 7(2)and 33, the candidate list can also provide information on substances in articles. The
candidate list has also to be seen as a way to officially identify substances that pose ahazard for which no agreed criteria are available (i.e. endocrine disruptors) or forwhich no official classification and labelling is available (i.e. PBTs and vPvBs)132.

EN

130

Study “Impact of the REACH regulation on the innovativeness of EU chemical industry”, CSES,
commissioned by the European Commission, March 2012.

131

More in chapter 2.4 on innovation in part II of this paper (page 133).

132

See document "Workshop on the Candidate List and Authorisation as Risk Management
Instruments, Workshop proceedings" Helsinki, 21-22 January 2009, [available onwww.echa.europa.eu].

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The Commission services believe that there is a need for a common view among
Member States, ECHA and the Commission on the use of the candidate list for
objectives other than the eventual inclusion of substances in Annex XIV.
Taking into account the relatively short experience in this area, the Commission
services believe that it is too early to reach a firm conclusion on the positive andnegative effects of inclusion of a substance in the candidate list. The reported
results133 can be considered as early indications of a trend, and they will need to be
confirmed once the authorisation process is fully in place. More information will also
be needed on the results of the implementation of Articles 7(2) and 33 of REACH.
The Commission services believe that the possibility of a "de-selection" from thecandidate list should be considered.
Prioritisation of substances for Annex XIV
The authorisation requirement is laid down in Title VII of REACH. Article 56
prohibits the placing on the market and the use of substances listed in Annex XIV (ontheir own, in mixtures and the incorporation of substances into articles) unless anauthorisation has been granted to the manufacturer, importer or DU for the use(s).
Annex XIV currently contains 14 SVHCs, included by two Regulations adopted in2011 and 2012134 respectively. Of the 14 substances currently in the Annex, 12 are
carcinogenic, mutagenic and/or toxic for reproduction (i.e. meeting the criteria of
Article 57(a), (b) and/or (c) of REACH), one is a PBT substance (i.e. meeting thecriteria of Article 57(d)), and one is a vPvB substance (i.e. meeting the criteria of
Article 57(e)).
Based on the procedure set out in Article 58 of REACH, substances from thecandidate list are prioritised for their inclusion in Annex XIV to REACH. Article
58(3) specifies a number of criteria for prioritisation (substances with PBT or vPvB
properties, with wide dispersive use or used in high volumes) to which a fourth
criterion has been added, namely the regulatory effectiveness of the inclusion of thesubstance. In addition, REACH requires that the number of substances and thetransitional arrangements included in Annex XIV take into account ECHA’s capacity
to handle applications in the time provided for. Based on ECHA’s recommendation,
the Commission adopts the decision to include substances in Annex XIV, in
accordance with a comitology procedure.
Of the substances currently in Annex XIV, the majority (11 substances) wereprioritised based on high volume together with the wide dispersive use criteria, and

EN

133

Study "Impact of the REACH regulation on the innovativeness of EU chemical industry”, CSES,
March 2012; RPA, Study “Assessment of health and environmental benefits of REACH”.

134

Commission Regulation (EU) No 143/2011 of 17 February 2011 amending Annex XIV toRegulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration,
Evaluation, Authorisation and Restriction of Chemicals (‘REACH’), OJ L 44, 18.2.2011, p. 2 andCommission Regulation (EU) No 125/2012 of 14 February 2012 amending Annex XIV toRegulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration,
Evaluation, Authorisation and Restriction of Chemicals (‘REACH’), OJ L 41, 15.2.2012, p. 1.

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two substances based on their PBT or vPvB properties together with the high volume
and/or wide dispersive use criteria. One substance was prioritised for regulatory
effectiveness reasons.
As indicated by ECHA135, the public consultations on the draft recommendation on
inclusion of substances in Annex XIV has shown a need to improve the quality of thecontributions from interested parties. Indeed, contributions are often made concerning
aspects which are not relevant for the prioritisation of a substance, such as theavailability and feasibility of alternatives, or socio-economic aspects concerning usesof the substance being recommended. The Commission services agree with ECHA in
its assessment that there is a need to remind stakeholders of the role of the public
consultation at this stage of the procedure, and of the relevant information for therecommendation. With regard to the public consultation, it has also been pointed out
in specific cases by stakeholders that the three-month period foreseen in Article 58(4)is not sufficient to be able to provide comments. In that regard it should be pointed outthat stakeholders should already be aware, at the stage of the public consultation
based on Article 59(4) with a view to the identification of a substance as a SVHC, thatthe substance may be included in the candidate list (if it meets one of the intrinsic
properties listed in Article 57) and thereafter be subject to the process laid down in
Article 58. In other words, stakeholders should see the identification of a substance asa SVHC as an “early warning”, to start gathering information with a view to the nextstage of the process. Still in relation to public consultation on the draft
recommendation, it should be noted that the progressively higher number ofsubmissions by third parties has started to create some challenges to the managementof the overall procedure and the capacity of the ECHA Secretariat and of the MSC toassess and digest any additional information provided and to fairly reflect it in therecommendation. The Commission services support ECHA’s commitment to issue arecommendation for inclusion in Annex XIV every year as it increases thepredictability of the process. Nevertheless, the Commission services would suggest to
ECHA, based on the experience gained, to review its internal procedures to ensurehigh quality recommendations.
Application for authorisation
An application for authorisation must be submitted to ECHA, whose Committee for
Risk Assessment (RAC) and Committee for Socio-economic Analysis (SEAC) are
required to adopt opinions on the application, and to send them to the Commission fora final decision to grant or refuse authorisation.
An important step in the implementation of Title VII was the adoption of the
Guidance on the preparation of an application for authorisation136 and the Guidanceon socio-economic analysis - Authorisation137, both aimed at assisting applicants for
135

The Operation of REACH and CLP 2011, European Chemicals Agency, 2011, p. 35.

136

Guidance on the preparation of an application for authorisation, Version 1, European Chemicals
Agency, January 2011.

137

EN

Guidance on the preparation of socio-economic analysis as part of an application forauthorisation, Version 1, European Chemicals Agency, January 2011.

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authorisation to prepare the application and the socio-economic analysis supporting
the application.
A question has arisen with regard to the applicability of the substitution planrequirement laid down in Article 62(4)(f) of REACH to applications for authorisation
based on Article 60(4) (the so-called “socio-economic route”). In that regard theCommission services recognise that substitution is the ultimate objective for bothroutes to authorisation (i.e. the so-called “adequate control route” laid down in Article
60(1) and the “socio-economic route” foreseen in Article 60(4)). The Commission
services are currently evaluating the appropriate procedure to reflect this requirement.
In the meantime, the Guidance on authorisation application138 clarifies that therobustness of the analysis of alternatives, and in particular the information provided
on research and development activities on alternatives, will be key in determining thelength of the review period of the authorisation. The Guidance also recommends that
"if there is a suitable alternative available on the market but not yet ready for an
immediate substitution (i.e. within the "sunset date") or another operator in the same
market has already or will switch in the short future to alternatives, the applicantsshould explain as part of analysis of the alternatives the actions that would be
required, as well as the time-lines, to switch to an alternative substance/technique."139
A question has also been raised, concerning whether an only representative (OR) is
legally entitled to apply for authorisation. In the Commission services’ view, even ifthat possibility has not been expressly foreseen in REACH, based on the principle ofnon-discrimination, an OR should not be deprived of this right. As a result of thisinterpretation, ECHA has communicated on its website that applications for
authorisation may also be submitted by an OR.
ECHA is preparing the procedures for the handling of applications for
authorisation140, and the Commission services are setting up its internal procedures forthe handling of the ECHA opinions and the decision-making to grant authorisations.
In particular, questions concerning the confidentiality of information, the format ofthe decisions and the internal Commission procedures to handle a potentially highnumber of application dossiers are being addressed.
Interface between authorisation and restrictions
In accordance with the provisions of Article 58(5) to (7), in principle there is no legal
obstacle in REACH preventing the authorisation and restriction processes from being
conducted in parallel for the same substance. However, ECHA141 acknowledges that,even where it is legally possible to launch the two processes in parallel, there may be

EN

138

Guidance on the preparation of an application for authorisation, Version 1, European Chemicals
Agency, January 2011.

139

Guidance on the preparation of an application for authorisation, Version 1, European Chemicals
Agency, January 2011, p. 25.

140

The Operation of REACH and CLP, European Chemicals Agency, 2011, p. 32.

141

The Operation of REACH and CLP, European Chemicals Agency, 2011, p. 33.

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other reasons not to do so, such as the effective use of resources by authorities andindustry, legal clarity and predictability. While sharing this view, the Commission
services acknowledge that there may be cases where it is appropriate to launch thetwo processes in order to target different uses. In particular it is evident that if asubstance poses an unacceptable risk that needs to be addressed on an EU-wide basis,the restriction process must be used through an amendment of Annex XVII to
REACH. The possibility for both the authorisation and restriction processes to takeplace in parallel reinforces the need for communication and coordination of theactivities of CAs, the Commission and ECHA in preparing proposals for identificationof SVHCs and for restrictions, in order to seek a common view early in the process on
the most appropriate risk management option for a specific substance.
In view of the above, the Commission services intend to launch a reflection with CAs
and ECHA on how to improve the coordination of work in the implementation of theauthorisation and restriction processes, with a view to ensuring that legal certainty andpredictability of the legal requirements is fully respected.
Annex XIII to REACH
Annex XIII was amended in 2011142 as a result of the review carried out pursuant to
Article 138(5) of REACH. The new Annex XIII has not yet been applied for the
purpose of identifying PBT and vPvB substances as SVHCs under Article 59. For the
purpose of registration of substances, a two-year transitional period was provided in
the Commission Regulation amending Annex XIII143, in order to allow registrants
sufficient time to update the registration dossiers.
Recommendations
7.1. The Member States and ECHA are encouraged to continue discussing and sharing at an earlystage RMOs analysis with the view to coordinate activities in relation to identification of SVHCs,
including "substances of equivalent concern" for which no guiding criteria are available yet.
7.2. The Commission services in cooperation with ECHA will in the short term increase its efforts for
identifying additional relevant SVHCs and will draft a roadmap in the framework of the RMO
process to include all relevant, currently known SVHCs in the candidate list by 2020
7.3. The Commission services and ECHA will consider information activities to facilitate theunderstanding of the authorisation process among all actors, including DUs and consumers.
Member States are encouraged to do the same.
7.4. Discussion should continue in order to obtain a common view on the use of the candidate list for
objectives other than the eventual inclusion of substances in Annex XIV.
7.5. ECHA should conduct information activities to improve the quality and the appropriateness of theinformation submitted during the public consultation on the draft recommendation for inclusion in
Annex XIV.

142

143

EN

Commission Regulation (EU) No 253/2011 of 15 March 2011 amending Regulation (EC) No
1907/2006 of the European Parliament and of the Council on the Registration, Evaluation,
Authorisation and Restriction of Chemicals (REACH) as regards Annex XIII, OJ L 69, 16.3.2011,
p. 7.
Ibid.

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8.

Restrictions

RESTRICTIONSThe REACH restriction process establishes clear deadlines for the adoption of
EU-wide measures to control and manage unacceptable risks posed to humanhealth and the environment.

The restriction process (Title VIII) sets up a "safety net" to manage unacceptable risks
to human health and the environment which are not adequately controlled by industry
and need to be addressed at EU level. The decision-making lies with the Commission,
which is empowered to adopt EU-wide restrictions concerning the manufacture, use
and/or placing on the market of substances on their own, in mixtures and/or in articles
under the comitology procedure, by amending Annex XVII. Restriction measures
could take the form of a total ban of a substance, or other measures to control andreduce the exposure and risk from the use of a chemical. They apply equally to all
products put on internal market, regardless of their origin, thereby being fair andtransparent to both non-EEA and EEA manufacturers.
REACH establishes clear deadlines which, especially when compared with theprevious legislative framework, were expected to considerably shorten the time fromthe moment the risk is identified to the adoption of the EU-wide measure to reduceand control such risk, resulting in a net gain in risk reduction. An EU-wide restriction
process was already introduced by Directive 76/769/EEC, in order to address risks at
Community level while removing the obstacles to trade created by different nationalrules concerning the marketing and use of chemicals, which affected theestablishment and functioning of the internal market. Regulation (EEC) No 793/93144
established rules in order to evaluate the risks of existing substances to human healthand the environment. However this process had led to very long timelines, stretchingover a number of years, from the initial risk evaluation until the adoption of therestriction. REACH addresses those shortcomings by streamlined procedures, inwhich ECHA plays a central role by coordinating the scientific and technical aspectsof the restriction process, as well as by setting strict deadlines in which the different
stages have to be accomplished by the different actors.
Moreover, transparency is expected to greatly improve, as the public is informed
through ECHA’s Registry of Intentions which substances are under scrutiny forpotential submission to the REACH restriction process. Once the process has started,
public consultation is also required at different stages of the procedure.
Finally the restrictions adopted under the previous legislative framework were takenover in Annex XVII of REACH145.

EN

144

Council Regulation (EEC) No 793/93 of 23 March 1993 on the evaluation and control of the risksof existing substances, OJ L 84, 5.4.1993, p. 1.

145

Following the adoption of REACH, Regulation (EC) No 552/22009 was adopted with the aim, inparticular, to incorporate amendments to the restrictions adopted under Directive 76/769/EEC from
1 June 2007 as well as to adapt the “old” restrictions to the terminology used by REACH.

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The standard route
Initiating the restriction process
Under the REACH restriction process, the Commission (Article 69(1)) or a Member
State (Article 69(4)) shall initiate the process leading to the adoption of restriction
measures, whenever they consider that the manufacture, placing on the market or useof a substance on its own, in a mixture or in an article poses a risk to human healthand/or the environment that is not adequately controlled and needs to be addressed.
In the case of substances on Annex XIV, under certain conditions, after the relevantsunset date ECHA has to initiate the restriction process (Article 69(2)). However, thisprovision has not been applied so far, as no sunset dates have passed yet.
The specific procedure set up by REACH in which, in addition to the Commission,
Member States as well as ECHA are given responsibility in initiating restrictions
constitutes a novelty approach. This approach is designed to ensure that, bycooperation between Commission, Member States and ECHA, the identified
unacceptable risks to human health and the environment are adequately assessed andaddressed at the appropriate level.
The Commission has the responsibility under Article 69(1) to initiate the restriction
process, in particular in cases where a specific risk to human health and/or theenvironment is identified under EU legislations or mechanisms or when an existing
restriction needs to be completed or updated.
Member States have similar obligation under Article 69(4). Consideration on risk
might be triggered, for instance, by the registration dossier or substance evaluation(Articles 42 and 48 of REACH), as well as by any other concerns identified on anational basis that would indicate the need for restricting the manufacture, placing on
the market and/or use of a substance. Once an uncontrolled risk has been identified,
Member States have to proceed under Title VIII. The obligation for Member States toinform ECHA and prepare an Annex XV dossier under Article 69(4) ensures that anassessment is done prior to introducing a restriction on the EU or national level, inorder to avoid a distortion of the internal market as well as to address the risk at theappropriate level.
Since the entry into effect of Title VIII in June 2009, four Annex XV dossiers havebeen prepared by Member States146 and one has been prepared by ECHA upon requestof the Commission147.
In essence, the factor triggering the restriction process is similar to that underDirective 76/769/EEC, i.e. an assessment of the inadequately controlled risk arisingfrom the use of a substance and of its need to be addressed at EU-wide level.
However, there is much more information available to perform such an assessment

EN

146

Dimethylfumarate and lead in jewellery (France), five phenylmercury compounds (Norway) and
four phthalates (Denmark).

147

Mercury in measuring devices.

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under REACH than within the previous legal framework. In fact, the registration
dossiers and chemical safety reports (CSRs) provided by industry have to containextensive information on substances and their uses, allowing a targeted risk
assessment and providing a more extensive set of information as support to the
propose risk management measures.
In addition, further data may be obtained through the stakeholders' involvement in the
preparation of an Annex XV. The Guidance on Annex XV for restrictions148 calls on
the involvement of stakeholders as early as possible when preparing the Annex XV
dossier, in order to facilitate the collection of the relevant data and improvetransparency.
The conformity check
The Annex XV dossier is submitted to ECHA and, if declared conform by ECHA's
Committees for Risk Assessment (RAC) and Socio-economic Analysis (SEAC) (bothdiscussed in [Title 10]) in line with Article 69(4), it is published on ECHA website
for the public consultation (Article 69(6)).
Regarding the conformity check, based on the experience gained with the fivedossiers submitted so far, it has become clear that for some cases this step is not easy
to fulfil for the Committees. In fact, in some cases the lack or the insufficient level of
information provided in Annex XV dossiers has caused problems to the Committees
in concluding on the conformity of the dossiers. ECHA has developed explanations on
conformity checks. However, the Commission services note that diverging views still
exist in relation to the level of information required for the conformity (or not) of thesubmitted dossiers and ways to address this issue should be explored.
ECHA Committees' opinion-making, interaction of the two Committees
The RAC and SEAC undertake their analysis as described in Articles 70 and 71. The
risk assessment is performed by RAC which represents under REACH the risk
evaluation body for chemicals, as explained in [Title 10].
REACH expressly requires taking into account the socio-economic impact when
adopting a restriction decision under the standard route.
Opinions of RAC and SEAC may diverge from each other or from the original
proposal included in the Annex XV dossier. It is important that opinions clearly
explain and justify why they present a different conclusion. This should be ensured bymore interactions between the committees during the opinion making process.
The socio-economic analysis can be part of the Annex XV dossier prepared by
Member States with the potential involvement of stakeholders. In any event, theinterested parties have the possibility to submit relevant information or even a socioeconomic analysis during the mandatory consultations, as detailed below.

148

EN

Guidance for the preparation of an Annex XV dossier for restrictions, European Chemicals
Agency, June 2007.

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Public consultations
Public consultations are needed at different stages of the process to ensure theinvolvement of all interested parties as well as greater transparency.
The Annex XV dossier is open to public consultation for a period of six months(Article 69(6)), allowing stakeholders to submit their comments, as well as additional
information in particular on risk assessment, availability of alternatives and socioeconomic data.
To improve the efficiency of the system, ECHA has suggested shortening the first
consultation period from six to three months. However, the Commission services
acknowledge that some industrial sectors are fragmented and collecting information
can be a long and difficult process for industry associations as well as for otherstakeholders. Also, the six-month period can be seen as very short when specificstudies would need to be launched by stakeholders. In that context, it appears evident
to the Commission services that a time period of six months is the minimum needed
to allow stakeholders to gather data and compile them. This has to be seen also in
relation to the situation experienced under the previous legislation, when stakeholders
were consulted and participated in the Commission working groups where therestriction measures were discussed and that, in most of the case, well beyond a sixmonth period.
A second public consultation then takes place on the draft SEAC opinion (Article
71(1)).
The consultation under REACH is conducted with full transparency with regard to thecomments submitted and the way they are taken into account by the dossier submitteror RAC or SEAC, respectively. In addition, ECHA becomes the central point ofcontact and coordination for all key players.
Restriction decision and comitology
The final restriction decision is taken by the Commission through the comitology
procedure. Given that it is based on the SEAC opinion, the performance of an impact
assessment is not applicable. Until now, the Commission draft Regulations have notdiverged from the opinions of the Committees.
Simplified procedure for restrictions of CMR substances for consumer uses
Article 68(2) provides for a simplified procedure where the Commission proposes
restrictions for a substance on its own, in a mixture or in an article classified as CMR
category 1A or 1B which could be used by consumers. In such cases, the standard
procedure following Article 69 of REACH (including the involvement of both
Committees and preparation of Annex XV dossier) does not apply. The simplified
procedure should allow a streamlined process to address risks to human health.
Such an approach is not new for substances and mixtures classified as CMR category
1A and 1B which, since 1994, were not allowed to be sold to the general public. For
the case of newly classified substances and mixtures that could be used by consumers,a continuation with the practice of the past is suggested as a general line. This isjustified by the potential wide exposure, possible misuse that could result from a

EN

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CMR substance or mixture made available to consumers and possible combined
exposure from different sources. Also in the case of existing information
demonstrating that, for a specific application, the risk is negligible, a time-limited
derogation may be considered with the view to provide an incentive for industry to
use alternatives. The Commission has already used that legal basis and adopted theRegulation No 109/2012 amending Annex XVII, entries 28 to 30149.
The novelty concerns the application of this simplified procedure to CMR substancesin consumer articles. At the moment, the Commission services are of the view that thesimplified procedure of Article 68(2) as applied so far to CMRs on their own and in
mixtures should not be applied in an identical way to CMR in consumer articles. Thismeans that the application of this provision should not result in a systematic
prohibition of the sale of all articles containing any newly classified CMR substances
to the general public. In addition, the Commission has the sole right of initiative forthese cases.
The Commission services are still exploring possible options to define prioritisation
criteria that would ensure that Article 68(2) is implemented in a pragmatic andproportionate way, taking in full account the need to preserve a scientific-based
decision-making process.
Transitional measures
In addition, Article 137 of REACH provided for transitional measures to allow the
work initiated under Directive 76/769/EEC to be finalised. This permitted theadoption of two amendments to Annex XVII concerning acrylamide150 andcadmium151 in 2011.

Conclusions
The Commission services have drawn the following conclusions with relation to theexperience gathered in the implementation of the restrictions:– The REACH restrictions enable a faster processing of risk management activities
on chemicals that are identified as giving rise to risks requiring action at the EU

EN

149

Commission Regulation (EU) No 109/2012 of 9 February 2012 amending Regulation (EC) No
1907/2006 of the European Parliament and of the Council on the Registration, Evaluation,
Authorisation and Restriction of Chemicals (REACH) as regards Annex XVII (CMR substances),
OJ L 37, 10.2.2012, p. 1.

150

Commission Regulation (EU) No 366/2011 of 14 April 2011 amending Regulation (EC) No
1907/2006 of the European Parliament and of the Council on the Registration, Evaluation,
Authorisation and Restriction of Chemicals (REACH) as regards Annex XVII (Acrylamide), OJ L
101, 15.4.2011, p. 12.

151

Commission Regulation (EU) No 494/2011 of 20 May 2011 amending Regulation (EC) No
1907/2006 of the European Parliament and of the Council on the Registration, Evaluation,
Authorisation and Restriction of Chemicals (REACH) as regards Annex XVII (Cadmium), OJ L
134, 21.5.2011, p. 2.

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level than the previous legal framework. It has therefore a high potential to deliver
health and environmental benefits.
– Although there is a net gain in risk reduction that can be attributed to REACH
restrictions, it is still limited at this stage of the REACH implementation.
– With REACH, transparency has greatly improved; stakeholders are informed ofwhat is going on under the restriction process through ECHA’s Registry of
Intentions and website. They can also provide input through the public
consultations required at different stages of the procedure.
– Diverging views still exist in relation to the information required for theconformity (or not) of the submitted dossiers.
– Coordination between RAC and SEAC opinions should be clarified and improved.
– Implementation of Article 68(2) still needs further work.
– Based on the review findings, the Commission services recommend the following
actions or measures to improve the degree to which the restriction process of
REACH is delivering its intended benefits:
Recommendations
8.1. The Member States are encouraged to increase their participation in the preparation of restrictions
dossiers and further coordinate their activities and ECHA is invited to continue supporting activities
for Annex XV dossier submitted by Member States.
8.2. Based on needs also identified in other legislative areas than REACH, the Commission services
will enhance efforts to identify and prioritise substance and their uses that should be subject torestrictions under Article 69(1).
8.3. The current timeframe for public consultation to ensure high transparency and stakeholders'involvement will be maintained.
8.4. RAC and SEAC should improve their coordination.
8.5. The criteria for the practical implementation of Article 68(2), in particular in cases of consumer
articles containing CMR substances will be considered.

EN

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9.

ECHA

9.1.

Process, internal structure and operations
ECHA is overall effective. ECHA prioritised effectiveness, i.e. delivering thenecessary output. In the Commission services’ view this was the right choice
for an Agency with a central role in an ambitious new piece of legislation.
Due to the focus on delivering output, efficiency was not maximal. In theCommission services’ view this reflects a justifiable prioritisation by ECHA.
However, the Commission services believe that the time has now come forconsolidation and learning from the experience of the start-up period, for
ECHA to become more efficient.

ECHA is a decentralised agency: it draws up opinions so that the Commission canenact legislative proposals (e.g. in the restrictions area) or take specific decisions (e.g.
granting or refusing authorisations). It has, in addition, own decision-making powers
allowing it to adopt individual decisions needing a defined technical expertise, underclearly and precisely defined conditions and without discretionary power (e.g. in thearea of evaluation); however, it is not allowed to adopt legislative measures of generalapplication. The range of powers given to ECHA is in line with the principles of the
EU legal order which impose constraints on the scope of the powers that can be given
to Agencies152.
ECHA was the first Agency to be immediately established in its definitive location;other comparable Agencies had started up at Commission premises in Brussels andmoved to their definitive location after some degree of organisational maturity had
been reached.
In ECHA’s start-up period, the initial team consisted of 38 seconded staff from theCommission selected for their special skills and/or relevant experience; some of themstayed on in the Agency as temporary agents. In addition, while the final stages of theco-decision process on REACH were ongoing, around 30 contract staff and 6 national
experts joined the Commission and worked on the so-called REACH Implementation
Projects (RIPs) referred to in the recitals of REACH, contributing to such essential
preparatory activities as developing the draft guidance which was subsequently madeavailable to ECHA, setting up the IT systems and preparing ECHA’s operational
structures. A number of these contract agents and national experts joined ECHA
afterwards. The overall level of preparedness and ability to transfer relevant
experience were some of the key factors contributing to ECHA’s speedy and effective
start-up.

152

EN

COM(2002)718 final, 11.12.2002, p. 8; COM(2008)135 final, 11.3.2008, p. 5.

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ENPart I.
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The study supporting the ECHA review153 confirms ECHA’s raison d’être, andaccordingly the Commission services recommend to maintain ECHA’s current role
under REACH and CLP.
The following observations can be made on ECHA’s internal structure:
The Management Board
All EU Agencies have a main governing body having a supervisory role, with general
responsibility for budgetary and planning matters as well as for reporting the
Agency’s activities to the EU institutions. ECHA’s Management Board appoints the
Executive Director, the accounting officer and the members of the Board of Appeal
and the Committees and exercises disciplinary authority over the Executive Director.
In addition, it adopts the internal rules and procedures as well as the financial rules of
ECHA and ECHA’s work programmes and general reports. It plays a key role in thebudgetary procedures of the Agency, including adoption of the final budget before thebeginning of the financial year. Finally, it may approve appropriate co-operation withstakeholders, third countries and international organisations. In this sense it exercises
overall authority over the functioning of ECHA and provides strategic direction, but is
not called to engage in regulatory chemicals policy.
ECHA’s Management Board comprises 27 Member State representatives nominatedby the Council, three Commission representatives, three stakeholder representatives
appointed by the Commission, two independent persons appointed by the European
Parliament and two representatives from EEA EFTA States (Norway and Iceland).
Since the signing of the Accession Treaty with Croatia, the Management Board has
decided to grant Croatia observer status and to invite a representative of Croatia toattend the meetings of the Management Board and the Committees. After having
worked under a more intense meeting schedule in ECHA’s start-up period, theManagement Board now meets quarterly. It has established a two-level governancestructure with six working groups which look into particular issues and meet
independently and the plenary meetings of the Management Board. This is consistent
with recommendation 10 of the Common Approach on decentralised agencies.
Despite overall performance being satisfactory, several suggestions have been madeto increase cost-efficiency of the functioning of the Management Board154, such as
reducing its size (including by not requiring all Member States to be represented) andfocusing on the management of ECHA rather than issues related to the day-to-day
running of ECHA or regulatory chemicals policy, as well as more detailed practicalsuggestions. However, the quality of decision-making was not put into doubt. For
most of these suggestions, it is for the Management Board itself to consider theirusefulness and to decide whether to act upon them. As for the suggestion to reduce
the size, this would necessitate an amendment of Article 79(1) REACH. Although
there are examples of EU Agencies with smaller Management Boards (especially

EN

153

Study “Review of the European Chemicals Agency”, PwC, funded by the European Commission,
March 2012, p. 8-9

154

Ibid., p. 45.

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EFSA), the predominant model is that of representation of all Member States which
has however been criticised as unnecessary, costly and ineffective155.
The Commission services encourage the Management Board and the ECHA
Secretariat to explore ways to increase cost-efficiency of the Management Board’sfunctioning, but at this stage sees no need to change the composition of theManagement Board through an amendment of REACH.
The Executive Director
All EU Agencies have an Executive Director who acts as their general day-to-day
manager. ECHA’s Executive Director represents ECHA, supports the Management
Board including by submitting to it draft work programmes, draft general reports anddraft documents relevant for budgetary procedures, deals with staff matters, manages
ECHA’s resources, ensures the various parts of ECHA function well and in a timely
manner, and where appropriate rectifies ECHA decisions following an appeal. The
Executive Director is supported by an Executive Office.
The Management Board appoints the Executive Director on the basis of a list of
candidates proposed by the Commission. In the start-up period of ECHA, and inrecognition of the fact that a general manager was necessary even before the selectionof candidates by the Commission and the Management Board’s establishment, which
both necessarily took time, the Commission appointed an Interim Executive Directorin accordance with Article 134(2)(a) of REACH as part of the Interim Strategy
towards ECHA operability. The fact that the Management Board saw this Interim
Executive Director as the most suitable candidate and appointed him to the position of
Executive Director allowed for a considerable degree of continuity in ECHA’s
management in the first years of its operation.
A complaint was filed with the Ombudsman regarding the first selection process forcandidates for the position of Executive Director conducted by the Commission. The
complainant felt that by proposing only two candidates to the Management Board, theCommission did not provide enough choice for the Management Board. After
examination, the Ombudsman closed his inquiry with a critical remark, finding an
instance of maladministration in that the Commission’s failure to document thereasoning underpinning the establishment of the shortlist of candidates made it
impossible to verify that the Commission did not unduly and arbitrarily restrict therange of candidates for the post of ECHA Executive Director and did not abuse its
discretion in the matter.
The Commission services acknowledge the role of the Executive Director and his
staff in the successful start-up and operation of ECHA. The Commission services
also acknowledge the central role and active interest of the Executive Director in theestablishment and working of the Directors Contact Group156. The Commission

EN

155

Study "Evaluation of the EU decentralised agencies in 2009". Rambǿll management,
commissioned by the European Commission, December 2009.

156

See [Sub-Title 3.2].

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intends to continue applying the highest standards in any future selection ofcandidates and encourages the Management Board to do the same in any futureappointment process.
The Secretariat
ECHA’s Secretariat currently comprises more than 500 staff members under theleadership of the Executive Director and divided over seven Directorates. They deal
with REACH tasks related to registration, pre-registration and data sharing,evaluation, authorisation, restrictions, establishment and maintenance of databases,
dissemination and communication, provision of technical and scientific guidance, (IT)tools and formats, technical and scientific support to Member State authorities andhelpdesks, technical and scientific support to international co-operation (at the requestof the Commission) and notification of ECHA decisions. In addition, they also deal
with CLP tasks related to classification and labelling and dissemination. The lists of
REACH and CLP tasks show that the role of the Secretariat is not purely
administrative but goes deeply into technical-scientific issues; in that sense the name
“Secretariat” may be a little limitative The Secretariat also has finance, humanresources, corporate services and legal departments. Specific to REACH, theSecretariat also assures the secretariat for the Committees and the Forum.
Currently, the Secretariat’s staff is mainly composed of temporary agents on five-year
contracts which can be prolonged157. There are limited numbers of contract agents(mainly support staff) and seconded national experts158.
The location of ECHA in Helsinki is reported to pose a particular challenge forstaffing159. In spite of considerable, and highly appreciated, efforts of Finland and theCity of Helsinki to create a welcoming environment for staff members and theirfamilies, promising candidates have been reported to turn down offers of employment
for reasons linked to the climatic conditions, the remoteness of the location comparedto the rest of the EU, and difficulties for spouses and partners to find attractive
employment.
The combination of the high workload and the difficulties to recruit sufficientnumbers of highly qualified staff may well require particular attention, and possibly a
strategy, from ECHA management to ensure that sufficient resources can be attracted
and can be sufficiently motivated to stay.
A continuing factor which has required reallocations of staff from other tasks has been
the slower than planned progress in developing and implementing the IT system. Thishas meant that on the one hand work needed to be done with less IT support than

EN

157

The establishment plan of ECHA has 456 temporary agent posts of which 447 were filled as of
31/12/2011.

158

92 contract agents and 5 seconded national experts were part of the staff as of 31/12/2011.

159

Study “Review of the European Chemicals Agency”, PwC, commissioned by the European
Commission, p. 65.

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planned and that more resources need to be dedicated to the development andimplementation of the IT systems..
The ECHA Secretariat will be entrusted with new responsibilities under the newBiocidal Products Regulation, and under the upcoming recast of the Regulation onexport and import of dangerous chemicals. This upcoming extension of theSecretariat’s tasks is testimony to the credibility and authority that ECHA built up
with the EU Institutions in the short years of its existence.
The Commission services commend the achievements of ECHA which were possible
thanks to the dedication and strong commitment of its staff and encourages ECHA’s
management to continue seeking ways to optimise the allocation of available staff totasks.
ECHA has identified a need for heightened internal co-ordination within ECHA toensure coherence in the activities160. The Commission services share this analysis andinvites ECHA to focus on pragmatic means of co-ordination, avoiding the need for
additional structures and horizontal services.
The Forum
No other EU Agency has a body comparable to ECHA’s Forum for Exchange ofInformation on Enforcement. The increased responsibility of operators for the safeuse of chemicals, a shift in mindset, that is at the very core of REACH, meant thatenforcement of the legislation needed to be strengthened at EU level. In this light it
was considered appropriate to provide a more formal framework for the co-operation
among enforcement authorities which had emerged under the previous chemicals
legislation161.
The Forum consists of 27 members, each appointed by their Member State, who haverelevant expertise and maintain contacts with their Competent Authorities (CAs). In
addition there are three members appointed by Iceland, Liechtenstein and Norway(EEA EFTA States) respectively. All of them are supported by the scientific andtechnical resources of their CA and ensure appropriate co-ordination with the work of
their CA. However, Member States cannot give instructions to Forum members
which are incompatible with their individual tasks or the tasks of the Forum.
Although the Forum currently has no co-opted members, its expertise is broadened by
the advisers that generally accompany members to Forum meetings. The Forum has
invited stakeholders’ organisations to attend some of its meetings. The secretariat of
the Forum is ensured by the ECHA Secretariat. The role of the Forum is discussed in
more detail in [Title 12].
ECHA has continuously increased the personnel in ECHA Forum Secretariat; theCommission services welcome this and invite ECHA to continue supporting improved
cooperation between the CAs and the enforcement authorities.

EN

160

The Operation of REACH and CLP, European Chemicals Agency, 2011, p. 80-81.

161

CLEEN – the Chemicals Legislation European Enforcement Network.

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ENPart I.
Operation of REACHECHAThe Board of Appeal
Only decision-making EU Agencies, which are a minority among the total number of
EU Agencies, have a Board of Appeal which decides on appeals against the Agency’s
decisions. ECHA’s Board of Appeal has strong similarities with its equivalents in
EASA, ACER, CPVO and OHIM. ECHA’s Board of Appeal provides a possibility oflegal redress which is quicker, less formal and less expensive than an action to the
Court of Justice of the European Union. Its composition of three members comprises
not only lawyers but also at least one technically qualified member, which allows
taking the technical-scientific aspects of each case into account where appropriate.
The Board of Appeal is supported by a Registry, which is part of the Secretariat. A
party not satisfied with a Board of Appeal decision can seek second tier legal redressby bringing an action to the Court of Justice.
Having a Board of Appeal organisationally within an Agency, and at Agency
premises, in charge of dealing with appeals against that same Agency’s decisions
poses specific challenges: not only must the Board of Appeal, and its Registry, be
independent from that Agency in its assessment and decision-making, but it also must
be seen to be independent. Both the Board of Appeal itself as well as ECHA havetaken organisational measures to guarantee the requisite independence and the ECHA
review showed that the Board of Appeal is perceived as a credible, independent
organisation.
In accordance with REACH requirements, the Commission has laid down thequalifications for the members162 and the rules of organisation and procedure163. The
Board of Appeal currently has one chamber of three members, but its rules oforganisation allow the necessary flexibility for it to be able to draw on additional
members to cope with any peaks in appeal numbers.
As of 15 April 2012, nine appeals against ECHA decisions had been filed with theBoard of Appeal. Two appeals were withdrawn by the appellants; three led torectifications of the ECHA decision by the Executive Director and were therefore nottreated on substance by the Board of Appeal; two led to extensively motivateddecisions of the Board of Appeal (one finding for ECHA, one finding for theappellant); two cases are pending. As a measure of good record, it should be notedthat no actions against Board of Appeal decisions have been brought to the Court ofJustice.
The Board of Appeal assists potential appellants through the publication of practicedirections and other useful documents on a special dedicated section of the ECHA
website, where appeal announcements and decisions are also published. Appropriate

EN

162

Commission Regulation (EC) No 1238/2007 of 23 October 2007 on laying down rules on thequalifications of the members of the Board of Appeal of the European Chemicals Agency, OJ L
280, 24.10.2007, p. 10.

163

Commission Regulation (EC) No 771/2008 of 1 August 2008 laying down the rules of organisationand procedure of the Board of Appeal of the European Chemicals Agency, OJ L 206, 2.8.2008, p.
5.

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modalities are in place to ensure the requisite confidentiality of parts of theinformation. In this way, an open but balanced approach to transparency is ensured.
In the framework of its review of the rules of organisation and procedure, theCommission consulted the Board of Appeal as well as stakeholders represented in
CARACAL to identify possible points for improvement. Some suggestions were
made, which have been further examined in the review of Regulation (EC) No
771/2008. As for other aspect relating to the Board of Appeal, the very limited
experience so far does not allow drawing definitive conclusions. Nevertheless, theCommission services acknowledge the fact that an appropriate framework is in place
to ensure the Board of Appeal’s independence from the rest of ECHA and shares thereported stakeholders’ assessment that it is a credible appeal body164.

9.2.

Committees
The ECHA Committees have been successfully established with active
participation from MS and EEA EFTA State and have provided the expected
input to the REACH and CLP processes.

Risk assessment is a matter for scientific experts, who are called to formulate an
independent scientific opinion, based on scientific evidence. The imposition of EUwide risk management on the other hand is a matter for those bearing politicalresponsibility, as it involves decisions regarding acceptability or non-acceptability ofrisk. The separation is organically established in most EU legislation designed toaddress risks, by entrusting the risk assessment role to scientific committees or theirequivalents, and the risk management role to a decision-making authority, generally
the Commission.
Under pre-REACH chemicals legislation, the idea of separation and independentscientific advice was already applied to some extent: EU risk assessment reports
prepared in accordance with Regulation (EEC) No 793/93 were evaluated by aTechnical Committee of New and Existing Substances composed of Member Stateauthorities’ representatives. Where appropriate, the Commission invited the ScientificCommittee on Health and Environmental Risks (SCHER) to give an opinion, not only
for chemicals under Regulation (EEC) No 793/93, but also for other questions relating
to examination of the toxicity and ecotoxicity of chemicals, biochemicals andbiological compounds whose use may have harmful consequences for human healthand the environment.
ECHA’s Committees are today’s conceptual equivalents of the Scientific Committees
managed by the Commission (e.g. SCHER, SCENIHR, SCCS) or the Committees andPanels operating in the context of comparable Agencies (e.g. EMA’s Committee for
Medicinal products for Human Use, EFSA’s Panel on plant protection products and

164

EN

Study “Review of the European Chemicals Agency”, PwC, commissioned by the European
Commission, p. 40.

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their residues). Nevertheless, specific aspects of the REACH system imply that
ECHA’s Committees present some original features compared to other known
committees. As explained below, the Member State Committee (MSC) falls nearlycompletely outside the classic committee paradigm.
Members of the Committee for Risk Assessment (RAC) and of the Committee forSocio-economic Analysis (SEAC) are appointed by the Management Board, uponnomination of candidates with relevant experience by Member States. At least one,and no more than two members nominated by each Member State can be appointed inthis way; the RAC currently has 41 members, the SEAC 30 members. Members of
the MSC are appointed directly by the Member States, each appointing one member;also Norway as an EEA EFTA State has appointed one member.
All Committee members are supported by the scientific and technical resources of
their Member State, who must provide them with adequate scientific and technicalresources. All Committee members ensure appropriate co-ordination with the work of
their CA, who facilitate the Committees’ activities. However, Member States cannot
give instructions to Committee members which are incompatible with their individualtasks or the tasks, responsibilities and independence of ECHA. The secretariat of theCommittees is ensured by the ECHA Secretariat.
The close link, embedded in REACH, between Committee members and CAs may
appear unusual. The members of Scientific Committees like SCHER, SCENIHR and
SCCS or EFSA’s Panels are nominated following a call from expressions of interest,
without link to Member States. On the other hand, the ECHA model for Committee
membership is closely related to that of some of EMA’s Committees, whose members
are nominated by Member States and supported by the scientific resources of CAs.
The ECHA model was chosen deliberately, to ensure the best possible combination
between ECHA independence, reliance on experience with the previous chemicals
legislation, and avoiding draining national authorities’ resources towards ECHA.
Nevertheless, it is reported that some of the interventions in RAC and SEAC appear
conditioned by the respective national chemicals policies, although this seems to havebeen somewhat mitigated as the Committees gained maturity165.
In addition to the tasks discussed below for RAC and SEAC specifically, REACH
envisages the possibility for those two Committees to draw up opinions on any otheraspects concerning the safety or use of substances on their own, in mixtures or inarticles, at the request of the Executive Director. This possibility was prevailed upona first time to request RAC to evaluate new scientific evidence regarding the use ofboron compounds in photographic applications. Such evaluation was needed in orderto justify any derogation from the ban of boron compounds classified as CMR andsupplied to the general public. More use of such possibility may be envisaged in the
future to support the Commission decision-making process.

165

EN

Study “Review of the European Chemicals Agency”, PwC, commissioned by the European
Commission, p. 38.

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ECHAAll ECHA Committees attach great importance to transparency and have invitedstakeholders’ organisations to attend and intervene in their meetings, although parts ofmeetings where issues of a confidential nature are discussed are held behind closed
doors. Criteria for the identification of relevant stakeholders were laid down by theManagement Board in accordance with Article 108 of REACH and are being applied.
The Committee for Risk Assessment
The RAC’s core competence and expertise – risk assessment - come closest to thoseof other Scientific Committees and Panels, although the fact that it plays roles ofdifferent nature under different pieces of legislation (REACH and CLP) is unusual.
Its main responsibilities include opinions on authorisation applications and on
proposals for restrictions as well as for harmonised classification and labelling (thelatter under CLP). The RAC‘s opiniopns are prepared by a rapporteur, possibly
assisted by a co-rapporteur, appointed among its members. CAs are paid for
rapporteurs’ work (except in the case of harmonised classification and labelling) inaccordance with Article 74(4) of REACH and Article 14 of Regulation (EC) No
340/2008166. The rapporteur’s draft opinion is discussed in a working group and thenpresented to the plenary meeting and the final opinion adopted, where possible byconsensus, otherwise by majority, recording any minority position, and taking into
account stakeholders’ comments in line with the applicable REACH or CLP
provisions.
In ECHA’s start-up phase, opinions of RAC were not called for very often and thisgave the Committee ample time to discuss its working procedures and approaches,and debate in details all aspects of opinions. With the exception of the authorisation
process, other REACH processes where RAC plays a role and the process fordelivering opinions on proposals for harmonised classification and labelling under
CLP are now more or less at cruising speed. This has meant a continuous increase in
the RAC’s workload which is anticipated to continue167. The workload combinedwith the legal deadlines for delivery of opinions creates pressure on the RAC whichneeds to continue looking for more efficient ways of working and must be able to relyon strong support from the Member States towards their RAC members in particularfor opinions concerning harmonised classification and labelling under the CLP
Regulation. Proposals for improvement are being examined and will need to be
implemented in the future.
The procedures and timetables were introduced by REACH with the intention toaccelerate the procedures as compared to pre-REACH and pre-CLP experience
Therefore the Commission services believe that at this stage, the most promising way
of dealing with the identified workload issues appears to lie in improved working

EN

166

Commission Regulation (EC) No 340/2008 of 16 April 2008 on the fees and charges payable to theEuropean Chemicals Agency pursuant to Regulation (EC) No 1907/2006 of the European
Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction ofChemicals (REACH), OJ L 107, 17.4.2008, p. 6.

167

Study “Review of the European Chemicals Agency”, PwC, commissioned by the European
Commission, p. 54.

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practices and Member State support, rather than extending the legal deadlines which
are already perceived by some stakeholders as excessively long.
Another concern that ECHA is invited to address relates to the need to improve theclarity for industry and other stakeholders on when and how they can provide input
into the processes and in what way ECHA reports on how this input is taken into
account.
The Committee for Socio-economic Analysis
No other Scientific Committees or Panels in ECHA deal with matters within thecompetency and expertise of the SEAC – socio-economic analysis. Its main
responsibilities include opinions on authorisation applications and on proposals for
restrictions. The SEAC's opinions are prepared by a rapporteur, possibly assisted by aco-rapporteur, appointed among its members. CAs are paid for rapporteurs’ work inaccordance with Article 74(4) of REACH and Article 14 of Regulation (EC) No
340/2008. The rapporteur’s draft opinion is discussed in a working groups and thenpresented to the plenary meeting and the final opinion adopted, where possible byconsensus, otherwise by majority, recording any minority position, and taking into
account stakeholders’ comments in line with the applicable REACH provisions.
Like the RAC, the SEAC had a relatively calm start-up period with time to discuss
working procedures and approaches as well as detailed aspects of opinions, but its
workload has increased and this trend is expected to continue168. The workload
combined with the legal deadlines for delivery of opinions and consultations, andespecially the interface with the RAC opinions and their timing, creates pressure on
the SEAC which needs to continue looking for more efficient ways of working andmust be able to rely on strong support from the Member States towards their SEAC
members.
Like for the RAC, the Commission services believe that at this stage, the mostpromising way of dealing with the identified workload issues for the SEAC appears tolie in improved working practices and Member State support. Additional help could
come from a better balance of the members' expertise accumulated within theCommittee in order to reduce risks of crossing into the domain of Risk Assessment
Committee.
The Member State Committee
The MSC’s role and nature are not only very different from traditional ScientificCommittees and Panels, but also from RAC and SEAC. Its main responsibilities
include consensus-building on draft evaluation decisions, proposals for identificationof substances of very high concern (SVHCs) to be subjected to authorisation andopinions on the ECHA recommendation for the inclusion of SVHCs in Annex XIV.
With regard to evaluation, its role is not limited to providing an opinion; it also brings
together in one assembly authorities from the Member States with a view to reachingconsensus on a draft decision to be taken by ECHA in case one or more of the CAs

168

EN

Ibid., p. 54.

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commented on the draft decision, in a field that under previous legislation belonged tothe core competences of the CAs. Similarly, with regard to decisions on identificationof SVHCs, it is called to reach consensus among the authorities from the Member
States, in case one or more of them commented on the proposed identification,
allowing ECHA to include substances into the so-called candidate list.
Where the consensus aimed for cannot be achieved, ECHA does not take anevaluation decision, for the first case, nor does it include the substances in thecandidate list, in the second case. Instead, the matter is referred to the Commission
who takes the decision in accordance with the comitology procedure. This referral to
the Commission for decision is another illustration of the extraordinary role andnature of the MSC which leads MSC members to some, perhaps too large, extent toengage in policy discussions rather than scientific-technical discussions. The MSC
has so far achieved consensus in nearly all cases; in the future it may need to consider
accepting that consensus is sometimes not possible and allowing the matter to bereferred to the Commission.
The MSC plays an important role also in the process of recommending SVHCs forinclusion in Annex XIV. Despite the fact that in this case the Committee does not takedecisions but gives only an opinion to ECHA, this stage is fundamental to assess thereaction of the Member States to the information provided by the stakeholders during
the public consultation, which is discussed in more detail in [Title 8]. The increasing
number of comments received and the difficulties encountered to get unanimity within
the MSC for supporting ECHA recommendations indicate a need to continue theefforts of working in an efficient way but also possibly the need to increase thedialogue and the early information of the stakeholders to improve the quality and theappropriateness of their involvement into the public consultation process.
Draft evaluation decisions prepared by the ECHA Secretariat are submitted to theCAs for comments; the draft decision only comes to MSC when amendments areproposed, otherwise ECHA takes the decision in accordance with the draft. However,as the evaluation as well as the authorisation process reach cruising speed, following
the first registration deadline, the upcoming adoption of the first CoRAP and thefourth round of recommendations for inclusion in Annex XIV, the workload for the
MSC can be expected to increase like for the other Committees. Also here there is aneed to continue looking for more efficient ways of working, e.g. by communicatingin more detail the rationale for decisions to CAs, so that comments are only triggeredin truly necessary cases169.

169

EN

Ibid., p. 54.

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9.3.

ECHA

Fees and charges
Since 2010, ECHA is fully financed by fees paid by enterprises. The amountsof the fees to be paid by enterprises should not be prohibitively expensive,
especially for SMEs.

In principle, ECHA activity under REACH and CLP are set up to be largely financed
from fees paid to it by operators. An EU subsidy is integral part of its budget, but thisis a balancing subsidy essentially meant to cover the start-up, when no or insufficientfees were coming in, as well as any income gaps caused by fee income fluctuations
due to no- or low-income periods between registration peaks (although these should
largely be mitigated by ECHA’s responsible management of the large incomesreceived during registration peaks). Following this system, ECHA has been selffinanced since 2010. The original Legislative Financial Statement published with theCommission’s REACH proposal foresaw a very simple fee structure (registration fees
for below and above 100 tonnes/year and authorisation fees)170. The European
Parliament and the Council introduced a number of individual fee items and also
important reductions and waivers for specific cases such as SMEs and consortia,
leading to a Revised Legislative Financial Statement171.
ECHA is expected to receive a balancing subsidy for REACH and CLP as of 2014.
The Commission proposal for the Multiannual Financial Framework 2014-2020
foresees rigorous cost savings and maximum efficiency at all levels. This also applies
to EU Agencies. Only the global amount per heading of the Multiannual Financial
Framework was included in the documents adopted by the Commission on 29 June
2011.
Taking into account the decision on the MFF and the experience gained from theoperation of the Regulation, the long-term resource planning as established by theLegislative and Financial Statement of the REACH Regulation may also need to be
examined
The principle that ECHA is supposed to be largely self-financing is further laid downin the requirement that the structure and the amount of the fees take account of thework to be carried out by the authorities and be fixed at a level ensuring that therevenue from fees combined with other sources of revenue, covers the cost of services
to operators, in accordance with Article 74(3) of REACH.
At the same time, there is a need to ensure that the amounts of the fees to be paid byoperators in order to gain or maintain market access do not become prohibitively
expensive, notably for SMEs. Another element is that fees can be used to promotecertain policy goals, such as in the case of REACH the aim of joint submission of

170

171

EN

Commission Staff Working Paper, [REACH] Extended Impact Assessment, COM(2003)644 final,
29.10.2003, p. 246.
Communication From The Commission To The European Parliament […] concerning theCommon Position of the Council on the adoption of [REACH], 12.7.2006, {SEC(2006)924}, p. 30.

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registration information. Both the promotion of SMEs and of joint submission ofregistration information are equally part of Article 74(3) of REACH.
A balanced approach combining all the above elements was the guiding principle for
the Commission in adopting Regulation (EC) No 340/2008 as well as Regulation(EU) No 440/2010172 (on CLP fees). Both Regulations provide for different fees fordifferent types of submissions and actions, and provide for reductions for medium,small and micro enterprises (who can benefit from reductions of 30%, 60% and 90%
respectively), as well as, in the case of REACH fees, for joint submissions of
information; moreover, no fees are due for registrations for substances in the 1-10
tonne range where all the information required by Annex VII to REACH is provided.
Special guidance has been made available allowing companies to verify if they are
eligible for SME reductions173. Nevertheless, when special reductions are possible,
the risk of abuse or accidental misuse is always present. To ensure that the special
facility benefits those and only those for whom it is meant, namely SMEs, throughsignificant reductions, Article 13 of Regulation (EC) No 340/2008 and Article 5 ofRegulation (EU) No 440/2010 foresee the possibility for ECHA to demand the full fee
as well as an administrative charge in case a company claims SME status but is unable
to prove entitlement. The legality of Article 13 of Regulation (EC) No 340/2008 is
being contested in the Court of Justice of the European Union.
Registration fees are levied through an invoicing system: operators are only required
to pay when they receive an electronic invoice from ECHA. ECHA conducts theinvoice process for registrations in parallel to the technical completeness check. Firstan initial deadline for payment is set – generally 14 days or 30 days for pre-registeredsubstances less than two months before the applicable registration deadline. If no
payment is received within the deadline, a second deadline is set. If no payment isreceived within the second deadline, the process to reject the dossier is initiated, as
Article 20(2) of REACH requires payment of the registration fee for a registration
dossier to be complete, but a short waiting period for verification is always allowed,
to ensure that ECHA does not reject registrations because of delays in banktransactions. If a registration is rejected because missing information was not
submitted or because the registration fee was not paid within the deadlines set, the fee
is not refunded or credited, in accordance with Article 3(7) of Regulation (EC) No
340/2008.
Late payments of registration fees have been the object of two decisions of ECHA’s
Board of Appeal. Both decisions concerned cases where the registration fee had been
paid after expiry of the second deadline set and, accordingly, the registration rejected.
In the first case, the appellant requested that ECHA’s decision be annulled, aregistration number assigned and the registration fee accepted, arguing that it had

EN

172

Commission Regulation (EU) No 440/2010 of 21 May 2010 on the fees payable to the European
Chemicals Agency pursuant to Regulation (EC) No 1272/2008 of the European Parliament and of
the Council on classification, labelling and packaging of substances and mixtures, OJ L 126,
22.5.2010, p. 1.

173

See [Title 3].

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fulfilled its obligations but had paid the fee too late due to an internal mistake. The
Decision of the Board of Appeal of 7 October 2011 confirmed that ECHA had acted
correctly in rejecting the registration. In the second case, the appellant challenged thedecision to the extent that ECHA decided not to reimburse the registration fee paid.
The Decision of the Board of Appeal of 10 October 2011 found that ECHA had notprovided clear enough information to the registrant on the deadline for payment of thefee, and ordered the refund of the registration fee. Meanwhile ECHA has undertaken
to carefully review its communications in the light of the latter decision, to make thedeadline for payment absolutely clear as well as the consequences of late payment.
REACH fees may be adapted to inflation. The Commission had proceeded to annual
reviews to decide whether an amendment of the amounts was due; up until now, noneed was identified to adapt amounts to inflation, taking into account the relatively
low inflation rate and the policy of the Commission to support economic operators, inparticular SMEs in times of economic downturn.
In line with Article 74(4) of REACH and Article 14 of Regulation (EC) No 340/2008,
a proportion of the fees collected by ECHA is transferred to CAs for work related to
substance evaluation and rapporteurs' work in the RAC and the SEAC. The
framework of these transfers is defined by a decision of ECHA's Management Board.
The scale of payments is based on Eurostat data using price level index (25%) andgross annual earnings in industry and services (75%). This system is currently underreview by the Management Board as the Board has observed a large variation between
Member States in the scale of payments and the data used might not reflect correctly
the average salary of scientific staff in Member States.
ECHA has provided the following suggestions related to fees174: (1) establishing a
specific inquiry fee to avoid inquiry free riding; (2) requiring separate payments fordifferent confidentiality claims; (3) ensuring remuneration under CLP for rapporteursfor harmonised classification and labelling proposals that are based on registration
dossiers; (4) achieving a desired degree of self-financing for the Board of Appeal
through appeal fee revenue; and (5) ensuring sufficient coverage of all regulatory
resources needed for processes for which no subsidy is assumed to arrive. Although
the Commission services are still considering these suggestions in detail, it is asserted
that changes in the fee regime do not justify a revision of REACH. In any event, theCommission is in the process of reviewing Regulation (EC) No 340/2008 by 1
January 2013, with a view to amend it, if appropriate, taking into account in particular
the costs of the Agency and the related costs of the services provided by thecompetent authorities of the Member States.
The Commission services acknowledge the contribution of SMEs to the EU economy,
including in the chemicals fields, and recommends to continue providing them special
status through significant fee reductions.

174

EN

The Operation of REACH and CLP, European Chemicals Agency, 2011, p. 21, 24, 65, 68 and 81.

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Recommendations
9.1. ECHA has completed the transition to a mature organization; it now has to enhance its resource
efficiency.
9.2. The Committees of ECHA need to continue looking for more efficient ways of working and must beable to rely on strong support from the Member States.
9.3. The review of the Fee Regulation needs to consider the suggestions made in the ECHA report.

EN

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10.

Competent Authorities

COMPETENT AUTHORITIES
Comptetent Authorities are important players in the implementation of
REACH. All Member States have appointed Competent Authorities, andfulfilled their tasks, although concerns have been raised in relation toadequacy of resources committed by MS.

Article 117(1) of REACH states that “Every five years, Member States shall submit to
the Commission a report on the operation of this Regulation in their respective
territories, including sections on evaluation and enforcement as described in Article
127. The first report shall be submitted by 1 June 2010.”
This section summarises the responses received from the Member States and EEAEFTA States by 1 June 2010. However, although several Member States have morethan one Competent Authority (CA), the responses received were from one CA per
Member State. As a result, in most instances the information related mainly to theactivities of the respondent CA, with only limited information on the roles andactivities of other CAs within the same Member State.
Given that this was the first reporting activity under this obligation, the Commission
will discuss how future reporting can ensure that information on the entirety ofactivities performed by all CAs within a Member State is captured.
Competent Authorities: Coordination, cooperation and information exchange
There are 40 REACH CAs operating in the EU Member States and EEA EFTA States(in this title collectively referred to as “Member States”), reflecting that seven of theMember States have more than one CA. This section presents a summary of theanalysis of the information from the first set of Article 117(1) reports submitted to theCommission by CAs.

Industry andEconomyCompetition

Employment

Regional
Development

Food andAgriculture

Health and
Safety

16
14
12
10
8
6
4
2
0
Environment

Number of CAs

Figure 2. Areas of responsibilities of national institutions nominated as CAs.

Notes: Up to 3 main areas of responsibilities have been identified per individual CA. Only EU CAs have been taken into
account.

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Competent Authorities

The “Competent Authorities for REACH and CLP (CARACAL)” is a Commission
expert group that brings together all CAs to facilitate cooperation between CAs, andbetween CAs and the Commission and ECHA, on the implementation and functioningof REACH and CLP in their respective areas of responsibility.
CARACAL is working effectively. Some Member States provide more resources thanothers, but this in some cases is simply a reflection of the resources available within
Member States for their CA(s).
However, the 15 CAs that provided comments expressed concerns that the resources
allocated to them are inadequate or limited due to:– an insufficient number of employees; and– inappropriate skill sets (e.g. particular emphasis was placed on the lack of expertisein socio-economic analysis and risk communication and of senior toxicology
experts).
The Commission services take note of this finding and intend to explore this further
with Member States.
Member States also have obligations in relation to ECHA Committees. In addition,
there is a range of other bodies designed to facilitate the coordination, cooperation,and information exchange related to specific functions of REACH (e.g. the Forum175
and HelpEx176).
ECHA, the CAs and the Commission services are positive about the quality of theirinteractions overall, both formal and informal. According to the reports the work of
the Committees was considered by CAs to be above average and ECHA is largely
positive regarding their communication with the Commission. CAs in general felt theeffectiveness of communication and collaboration to be average or above, between
themselves and (number of CAs expressing this opinion):– CAs of different Member States (28);– ECHA (28);– the Commission (30); and– the ECHA Committees (30).
Operation of REACH
Member States were asked to report their experience in the following areas:

EN

175

See [Title 12].

176

HelpNet Exchange - a secure web-based discussion platform set-up by ECHA which allows
members of the helpdesk network to discuss difficult questions, to cooperate and to support one
another on a daily basis

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Competent Authorities– Risk Communication Network: a voluntary body of CAs organised by ECHA tosupport the cooperation obligation as set in Article 122 of REACH, the Risk
Communication Network (RCN) focuses on risk communication to the generalpublic. The six CAs that commented on the RCN felt that this was a well organised
body that was an important and valuable venue for sharing expertise/experiences of‘risk communication’ between Member States, as well as a source of training(information volunteered by CAs and not asked in Member State questionnaire).
– Duty-holders (registrants): 12 CAs provided estimates of the total number of likely
duty-holders for each of the years 2007 and 2008 and 15 CAs provided estimatesfor 2009. The remaining CAs submitted either a blank response or stated that suchdata were not maintained/collected. However, there are reasons to suppose that thedata provided may not relate to a common metric, a view supported by the fact thatCAs had not been provided with guidance on how these estimates should be
calculated. Hence no sound conclusions could be drawn.
– Information in the supply chain: Member States were not asked to report on theactivities of duty-holders regarding the supply and movement of information in the
supply chain. However, in their responses regarding helpdesk support provided toindustry, it is clear that advice was provided by Member States on downstream
user obligations, the operation of SIEFs and safety data sheets.
– Annex XV dossiers (authorisation): The identification of Substances of Very High
Concern (SVHCs) is the key requisite for triggering the authorisation provisions of
REACH. 21 CAs indicated that their Member State had been involved in someAnnex XV dossier-related activity for the identification of SVHCs. Activities
range from developing full dossier to commenting on a dossier prepared by anotherMember State or ECHA.
In general, CAs felt that they did not have the experience to comment on the“reasonableness” of the time spent following up Member State dossiers or acting as
co-rapporteur. However, the Danish and Swedish CAs predicted that Annex XV
dossier work would not be resource-demanding but stated that the time/resources
requirements varied significantly between dossiers. These comments applied to all
Annex XV dossiers, not just those for the identification of SVHCs.
Eight CAs indicated that industry was involved in the preparation of Annex XV
dossiers for SVHC identification within their Member State. However, the level ofindustry contribution varied greatly between Member States.
– Effectiveness of RAC and SEAC: The views on the effectiveness of the Committee
for Risk Assessment (RAC) and the Committee for Socio-economic Analysis(SEAC) were mixed, with respondent CAs commenting on the usefulness of thesecretariats and procedures whilst also raising concerns regarding the workload andavailability of resources of the Committees.
– Annex XV dossiers (restriction): 13 CAs indicated that their Member State had
been involved in some Annex XV dossier-related activity. However, the activity
may have only involved commenting on a dossier prepared by another Member
State or ECHA.

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Competent Authorities– Dossier and substance evaluation: Nine CAs reported having been involved in
substance evaluation. However, several CAs noted that as substance evaluation
has not yet begun, they had not been involved.
– Alternative testing: Responses from all CAs indicate that 20 Member States havemade contributions to EU and/or OECD work on the development and validationof alternative test methods by participating in relevant committees.
17 CAs provided data on overall public funding for national research and thedevelopment of alternative testing methodologies, with nine CAs reporting
expenditure of more than € 100 000 per year each. However, from comments
provided by CAs it is possible that the expenditure reported for some Member
States includes not only funding of national research projects but also contributions
to EU and/or OECD work.
Enforcement
Administrative structures differ between Member States and often more than one
authority plays a role in the enforcement of REACH, which can bring differing
challenges. Co-operation between CAs and enforcement authorities also differs
between Member States. According to Member States reports five of them have asingle CA and a single enforcement authority and nine have several CAs and multiple
enforcement authorities (national, regional, local). The rest typically has a single CA
and several enforcement authorities.
However, issues related to this area are discussed in [Title 11].
Guidance and support– Helpdesk organisation and resources: All CAs manage their REACH helpdesks
internally, except for the Netherlands, which still, however, retains the control over
the Member State helpdesk. A further six CAs indicated that they outsourced atleast some helpdesk enquiries. The greatest number of enquiries was received bye-mail and then by telephone with a small minority of Member States not having
both of these options available. 22 Member State helpdesks also handle enquiries
relating to CLP and 18 helpdesks provide specific advice to small and mediumsized enterprises (SMEs). No helpdesks receive funding outside of Member State
governments.
– Member State helpdesk activities: The number of inquiries received by helpdesks
varied significantly. However, two-thirds of the Member States receive between
100 and 1 000 inquiries per year. The greatest number of inquiries related toregistration or pre-registration, the majority from SMEs. 64% of inquiries wereconsidered to be straightforward with 36% described as complex. On average,
straightforward inquiries received a response within one week (and often within aday) while complex inquiries were dealt with within two weeks.
– Cooperation between Member State helpdesks: For the majority of Member States,
the level of cooperation within the REACH Helpdesk Correspondents' Network(REHCORN, now renamed Helpnet) was significantly greater than the level ofcooperation outside of REHCORN. However, six CAs felt that there was no

EN

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difference. 19 of the 30 helpdesks make use of REACH Helpdesk Exchange
Platform (RHEP, now renamed HelpEx) at least weekly.
– Awareness-raising activities: In general, CAs employed a wide range ofawareness-raising activities, with the greatest level of activity focused on the entry
into force of REACH. CAs found speaking events, telephone contact and leaflets
most effective at awareness-raising.
– Member State websites: All Member States except Austria and Greece have a
REACH-specific website or webpage(s). Ten Member States have single
webpages dedicated to REACH and the remaining 18 Member States have multiple
such webpages as part of their website. Topics of interest comprised REACH
news/updates, company obligations, (pre-)registration, exemptions fromregistration, authorisation, socio-economic assessment (IT only), classification andlabelling and FAQs.
– REACH guidance documents: Effectiveness of Partner Expert Groups (PEGs): Themajority of Member States had actively participated in PEGs. A minority of CAs
was supportive of the organisation of PEGs although with some reservations.
REACH aims: Protection of human health and environment– Article 129 of REACH: No MS indicated that they had made use of the safeguardclause of Article 129 REACH.
– Effectiveness of REACH for the protection of human health and environment:
With the exception of Italy, all CAs felt that the effectiveness of REACH inprotecting human health and the environment was best assessed at the level of the
EU rather than at a national level.
REACH aims: Enhancing competitiveness and innovation and the single market
All CAs except Italy stated that enhancing competiveness and innovation should beassessed at the EU, not the national level.
Suggestions for improving Article 117(1) reporting
Responses from CAs (within and separate from Article 117(1) reports) and the legal
requirements for Member States reporting set out in REACH were analysed with theintention of identifying possible improvements to the content and format of future
Article 117(1) reports.
On the basis of this first reporting experience and a technical analysis177 theCommission services see a need to improve the reporting process and will consider
how this can be best achieved.

177

EN

Study “Technical assistance to prepare the Commission report on the operation of REACH”, RPA
and Ökopol, commissioned by the European Commission, 2012

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Conclusions and recommendations
The reporting of the Member States provides a first snapshot of the functioning of
REACH. Recommendations and conclusions on specific aspects e.g. authorisation,
are provided at those corresponding sections of this document.
The Commission services acknowledge the challenges faced in this first reporting
round and the efforts made by the CAs to fulfil this obligation.
Recommendations
10.1. The Member States should improve the reporting quality by exploring ways in which more robust
information can be provided through the questionnaire. It will be examined how the reporting
process (including IT tools used and reporting format) can be made more user-friendly for theMember States.
10.2 The Member States should explore if the resource constraints that appear to be acting on the CAs
can be addressed by improved ways of working e.g. wider sharing of best practice across Member
States.
10.3. Further assistance to Member States and the CAs will be explored e.g. through development oftools for assessment of competiveness and innovation.

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11.

Enforcement

ENFORCEMENT
A strong and harmonised approach towards enforcement in the Member States
is vital for delivering objectives of REACH and CLP Regulations. Achieving
this is a challenge and Member States are actively cooperating within the
Forum to enhance compliance.

The aim of the national enforcement systems is to ensure the implementation of
REACH. A strong and uniform enforcement of REACH throughout the EU members
and EEA EFTA States (in this title collectively referred to as “Member States”) is
vital for delivering its objectives
REACH places different enforceable obligations on duty-holders. They can begrouped according to the main REACH processes: registration-related duties, supply
chain-related duties, authorisation and restrictions.
Related to the obligations prescribed by REACH, CLP imposes additional obligations
including the basic obligation of classification and requirements to label and package
substances and mixtures according to hazard.
The enforcement of REACH and CLP lies with the Member States. The
harmonisation of enforcement amongst Member States was a key issue during thedevelopment of REACH. The REACH preamble stresses the importance ofstrengthening enforcement178. The Forum (an ECHA body) was created to coordinate
a network of Member State authorities responsible for the enforcement of REACH179.
It is a unique body and may serve as an example for other legislation.
Enforcement in Member States
In order to enable REACH to operate effectively in practice, Member States are
obliged to establish the necessary arrangements for its implementation. REACH
therefore requires the Member States to:– maintain “a system of official controls” and other activities as appropriate to thecircumstances (Article 125);– lay down the provisions on penalties applicable for infringement of REACH andtake all measures necessary to ensure that they are implemented (Article 126);– regularly report on enforcement (Article 127).
The Commission as the "guardian of the Treaties" oversees the fulfilment of theseobligations.
As reported in [Title 10], the administrative structures of enforcement authorities
differ from one Member State to another and often more than one national

EN

178

Recital (105) of REACH.

179

Article 76(1)(f) of REACH.

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Enforcement

enforcement authority plays a role in the enforcement of REACH. For example in the
Czech Republic the Czech Customs Administration checks the duties of importers,
focusing on safety data sheets, and the Regional Public Health Authorities checks theduties of manufacturers, importers, downstream users and distributors. However, theenforcement arrangements in many Member States, such as Germany, Spain and theUK, are more complex.
Since CAs have the scientific and political knowledge and national enforcement
authorities the necessary practical experience in implementation, a proper cooperationand information exchange between CAs and national enforcement authorities is
crucial to ensure the effective implementation of REACH.
The Forum
The Forum coordinates the network of Member States authorities responsible for
enforcement of REACH. It is required to spread good practice, identify enforcement
strategies, set up harmonised enforcement projects and joined inspections, provide
certain types of support to inspectors and liaise with industry and other stakeholders.
In addition to these activities which came into play "downstream" for provisions
already adopted, the unique expertise of the Forum is called to contribute to thequality of provisions still to be adopted through the Forum's upstream advice on
enforceability of restrictions proposals.
The formal structure of the Forum is further described in [Title 9]. While ECHA has
no direct enforcement responsibilities, it does have a number of tasks that at first sightappear to be enforcement, and in particular the completeness check and compliancecheck of the registration dossiers. ECHA may indicate to Forum members issues ofconcern and stimulate Member States to undertake enforcement actions to ensurecompliance with REACH. The Commission services welcome the initiative of ECHA
to inform Forum members on enforcement issues of concern (for example in case of
QOBL or registration of intermediates). The Commission services encourage ECHA
to establish a more systematic and regular information exchange on enforcement
issues between the Forum and other parts of ECHA.
The Forum conducts many of its activities through Working Groups addressing
particular enforcement issues; until now 14 such working groups have been set up andbenefit from the strong commitment of the vast majority of Member State
enforcement authorities.
The Forum requires national enforcers, some of whom had no previous experience
with coordination work at the EU level, to discuss with their counterparts in otherMember States and jointly come to harmonised projects and strategies, thus increasing
consistency in REACH implementation across the European Union. So far theForum's work appears to have had limited influence on the practice in Member Stateswith strong traditions of chemical legislation enforcement, but it appears to be
bringing real added value in others. Workload appears an issue for all members, who
conduct their Forum work on top of their “day jobs”.
Since its formation, the Forum has developed several documents illustrating its
approach of enforcement. The main ones are:

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Enforcement– the strategies for enforcement of REACH and CLP;
– the minimum criteria for REACH and CLP inspections;– the documents related to Forum's EU/EEA EFTA harmonised enforcement projects(REACH-EN-FORCE projects) to check compliance with REACH.
To ensure proper cooperation and information exchange between national CAs andnational enforcement authorities, the Forum has established a working group to
analyse the interlinks between ECHA, CAs and national enforcement authorities forthe different REACH processes. The Commission services welcome and encourage
the Forum initiative on this important issue.
The Forum’s workload is increasing and its members should receive full scientific,
technical and administrative support from Member States. Further prioritisation
efforts of enforcement and inspections across the European Union is needed in orderto target the limited resources of national enforcement authorities and maximise thebenefits from compliance activities.
The work already performed by the Forum is highly appreciated by the Commission
and CAs. The Commission services are encouraging the Forum to further strengthen
its efforts and focus on delivering its core tasks, which are pursuing harmonised
enforcement projects, joined inspections, exchange of inspectors and practical help to
local inspectors. The Forum should also consider facilitating exchange programmes
between Member States to allow for the dissemination of best practice and increase
harmonisation of enforcement activities.
Information exchange on enforcement
The key element of coordination of enforcement activities within and between
Member States is the exchange of information. For this the Forum and the Member
States have developed different systems. Some examples are:
– The information in REACH–IT databases, e.g. on companies and substances, isneeded for enforcement purposes. For this reason, in June 2011 ECHA establisheda REACH information portal for enforcement authorities (RIPE) containing a
selection of the most essential information for the purpose of enforcement. Before
RIPE was operational, some enforcement authorities had significant difficulties in
the planning and execution of their duties because of lack of a direct access torelevant data. Currently almost all Member States (except two) have access to the
REACH-IT system and can use it e.g. for enforcement activities.
– Ten CAs reported receiving enforcement referrals from other Member States.
However, in each case these were few in number.
– The most common mechanism used to share information (formal or informal)
within Member States is the organisation of meetings between CAs and national
enforcement authorities (e.g. Austria holds two per year). Furthermore, many CAs
provide oversight to the activities of the enforcement bodies and most CAs provide
training. The Commission services recommend sharing these practices among
other Member States.

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Enforcement– Information exchange on products posing a serious risk within Member States andbetween Member States is also ongoing via the notification by the authorities under
the Community Rapid Information System for non-food dangerous products(known as “RAPEX”), as required under Regulation (EC) No 765/2008180.
Enforcement activities
Enforcement strategies
A proper enforcement strategy should allow the enforcement activities to be mosteffective, i.e. providing for the greatest output with regard to compliance by using thesame amount of Member States resources. The Forum developed in 2008 a document
on enforcement strategy concerning REACH and subsequently updated it (in 2011) toincorporate the CLP requirements as well.
In their Article 117(1) reports, 24 of the 30 Member States indicated that they had(an) enforcement strategy(ies) that were in line with those devised by the Forum. Six
national enforcement strategies were not fully in line but two were very close to it and
one was reported to be revised to meet the Forum strategy. Each Member State
enforcement strategy was unique so as to better fit with different administrative
structures and based on their own experience from enforcing chemical legislation.
The Commission services consider the enforcement strategies would become more
effective by giving priority to assessing compliance of the exposure scenarios,
information in the supply chain (safety data sheets) and substances in articles. This
would allow enforcement authorities to assess compliance with registration,authorisation, restriction and classification and labelling requirements.
The information generated by the different REACH requirements can be relevant in
the enforcement of other EU legislation, including worker health and safety, industrial
pollution control, product requirements, market surveillance and customs. Therefore,
to improve efficiency of enforcement, the combination and/or coordination of
REACH enforcement activities with those under other EU legislation should beconsidered. This approach is also confirmed by the recent study on inspection
requirements for REACH and CLP181.
Inspections and investigations
For reporting purposes Member States were asked for data on the number ofinspections or investigations undertaken during 2007, 2008 and 2009 “in which
REACH was discussed or enforced”. However, it was clear that Member States use
inspections and investigations in very different ways within their overall enforcement
strategies and the Member States reports showed a high degree of variation between

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180

Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008
setting out the requirements for accreditation and market surveillance relating to the marketing ofproducts and repealing Regulation (EEC) No 339/93, OJ L 218, 13.8.2008, p. 30.

181

Study "Inspection requirements for REACH and CLP”, Millieu Ltd, commissioned by theEuropean Commission, 2012.

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them. Some Member States undertook tens of thousands of such actions per year andothers undertook less than ten, regardless of the size of the Member State. It would
appear likely that different Member States have different interpretations of the scopeof investigations.
Furthermore, a lack of consistency in the answers given to Article 117(1)questionnaires showed that it was not possible, e.g., to carry any type of statisticalanalysis on the inspection burden to duty-holders of different types and sizes.
However, from the most recent data available (2009), the main focus for inspection
activities up to that time would appear to have been on small and medium-sizedenterprises (SMEs). For all these reasons, the Commission services see as a priority
the development of European REACH Enforcement Indicators which would help tobetter know how REACH is implemented, help the Forum in fulfilling their tasks andhelp Member States in fulfilling their reporting obligations. For this exercise, theForum can play an important role.
The REACH-EN-FORCE-1 (REF-1), a Forum harmonised enforcement project,found that approximately 4% of the companies inspected were not complying with
their registration requirements. Furthermore, the Forum reported that 9% ofcompanies did not have safety data sheets available for inspection while the safety
data sheets provided by 16% of companies did not meet the requirements prescribedfor safety data sheets. Overall, the Forum found that 20% of companies were not infull compliance with the obligations checked in REF-1. The ongoing REF–2
harmonised enforcement project is focusing on the obligation of downstream users –formulators of mixtures. The scope of the planned REF-3 project will include theregistration obligations for importers, manufactures and only representatives (ORs) as
well as close cooperation with customs and compliance of ORs with their duties. The
Commission services are of the view that all Member States should participate in andreport to these harmonised enforcement project.
Also with regard to restrictions under REACH, it is to be noted that the enforcement
activities varies among Member States, which reflects the different priorities ofMember States authorities with regard to certain restrictions over others. In theCommission services' view, Member States should further improve prioritisation of
enforcement actions, exchange of information among enforcement authorities andcooperation with customs. These finding are confirmed by the recent Commission
study on enforcement of restrictions182.
Sanctions
The Article 117(1) reports and the findings of the harmonised enforcement projects of
the Forum (REF) describe a wide range of enforcement sanctions that are available tonational enforcement bodies. This include the prohibition to a company to place its
products (substances, mixtures or articles) on the market, large fines and/or prison
sentences, and the confiscation of illegal goods for those found guilty of breaching

182

EN

Study “Implementation and enforcement of restrictions in Member States”, Milieu Ltd,
commissioned by the European Commission, 2012.

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Enforcementa(some) provision(s). Enforcement actions and possible sanctions are assessed on acase-by-case basis.
The Member State systems typically describe a mixture of administrative and criminal
measures available to their enforcement authorities but some enforcement bodies have
only administrative measures available. The punitive measures described above are
typically preceded by non-punitive measures designed to bring companies into
compliance.
Stakeholders
Stakeholders, at a first instance, can approach their Member State enforcement
authorities to discuss their concerns. Furthermore, they can regularly attend Forummeetings where they can bring enforcement issues for discussion at the EU level.
Duty-holders have the possibility to address, as well, their national REACH and CLP
helpdesks which also have their regular meetings in ECHA. Furthermore, theCommission and ECHA regularly organise conferences or ad-hoc meetings forstakeholders where enforcement issues are also discussed (for example, theCommission Conference on REACH and CLP Enforcement held in Brussels on 1
March 2012).
The survey on industry183 found that 45% of companies had as yet no experience of
REACH inspection or enforcement. The remaining companies were positive overall
regarding their experience of such activities by regulators.
Stakeholders commented on the significant differences in approach between Member
States with regards to inspection requirements, penalties and the role of customs,
without specifying the degree and experienced impacts of these differences. The
Commission services are closely following these issues and addressing theappropriate issues at the appropriate level. Comments were also received regarding
the lack of resources for inspection and/or enforcement available to authorities insome Member States.
Conclusions
A strong and harmonised approach towards enforcement of REACH throughout the
EU/EEA EFTA is vital for delivering its objectives. The enforcement of REACH lies
with the Member States. In order to enable REACH to operate effectively in practice,Member States are obliged to establish the necessary arrangements for its
implementation.
The practical arrangements for enforcement vary between one Member State toanother, allowing Member States to operate the system that best fits with theiradministrative structures or legal cultures. Enforcement authorities typically have a
mixture of administrative and criminal measures at their disposal.

183

EN

CSES was commissioned by the Commission to conduct an industry survey with the aim to study
industry impacts of REACH. More than 1500 companies participated in the survey which ran overthe period of July to September 2011.

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The coordination of enforcement activities within Member States in order to integrateother EU legislation is considered essential to maximise the effectiveness of theexisting resources.
The work already performed by the Forum has shown that the Member States foundthis network very useful. The Commission services encourage Member States toenhance their support to Forum members by providing full scientific, technical andadministrative assistance. Further prioritisation of enforcement and inspections acrossthe EU is needed to focus the limited resources of national enforcement authorities inorder to achieve the most benefits as regards compliance and objectives of REACH.
The Forum is encouraged to further strengthen its efforts and focus on delivering its
core tasks, which are pursuing harmonised enforcement projects, joined inspections,exchange of inspectors and practical help to local inspectors. The Forum should also
consider facilitating exchange programmes between Member States to allow for the
dissemination of best practice and increase harmonisation of enforcement activities.
Despite the fact that according to the reports available, Member States are undertaking
their tasks entirely, and in most of the cases through common strategy(ies), a
harmonised enforcement of REACH across Member States continues to be achallenge.
More consistent and comparable data from Member States on implementation of
REACH would allow having better overview and assessment of the actions to betaken. The Commission services consider that it will therefore assume a yet stronger
overview role in the development, use and analysis of the European enforcement
indicators, thus leading to a more in-depth examination of meeting the requirements
set up by REACH.
Recommendations
11.1 Member States should further focus their inspection/enforcement activities across the EU totarget limited resources where most benefit is to be expected.
11.2 Member States should improve coordination of their inspection and enforcement activities under
REACH/CLP and other EU legislation.
11.3 Enforcement indicators will be developed in liaison with the Forum. This will help to a) have betterknowledge of the implementation of REACH, b) Forum to better fulfil their activities and c) achievea more harmonised and systematic approach concerning the collection of information andreporting.
11.4 The Member States should consider the Forum as a single point of discussion, collation andcompilation of information on REACH / CLP enforcement activities.
11.5 ECHA is invited to make more systematic use of information from all relevant ECHA activities tobetter enable targeted enforcement activities by the Member States.

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12.

Information

INFORMATION
Through ECHA’s dissemination activities the world is being transformed into“a world of a lot of knowledge on chemicals.” However, it took time for
ECHA to get to this stage.

ECHA’s dissemination activities
REACH is designed to lead to an unprecedented level of collection and generation of
information on chemical substances. Compiling a registration dossier and sending it
to ECHA does not mean that the information is buried in a data cemetery, only to bemined if and when the desire or need of Competent Authorities, ECHA or
Commission arises. As explained in [Titles 2 and 6], the information is to lead tobetter management of chemical risks by registrants and downstream users themselvesin the first place. In addition, however, REACH aims to provide EU citizens with freeand easy access to basic data on chemicals held in ECHA’s database, so as to allow
them to make informed decisions about their use of chemicals (recital (117)). Article
119 of REACH lists the information to be published by ECHA; in the case of
information listed in Article 119(2), companies can make justified requests for the
information not to be published. Information listed in Article 118(2) is not publishedby ECHA, but can be disclosed when urgent action is essential to protect humanhealth, safety or the environment. PPORD information is not published under Article
9(9).
In the first years of ECHA's operation, its website was not generally perceived to beuser-friendly. It was criticised for lacking clarity in the routing, making it sometimes
difficult to find documents fast, and for its limited search facilities184. The ECHA
website was revamped towards the end of 2011185, improving its transparency andaccessibility.
ECHA’s current website (www.echa.europa.eu) has different tools and facilities tosearch for information on substances. The public database on registered substances
was launched in December 2009186 and allows searching for substance properties andother information from registration dossiers. As per 16 March 2012, information on
4 326 substances could be consulted187. The Classification and Labelling Inventory
foreseen by Article 42 of CLP took longer to publish than expected, including by
ECHA itself188, and this raised concerns, but since February 2012 it is available forsearching. Data on candidate list substances in articles can be consulted as well, and

EN

184

Study “Review of the European Chemicals Agency”, PwC, commissioned by the European
Commission, p. 25 and 35.

185

The Operation of REACH and CLP 2011, European Chemicals Agency, 2011, p. 24.

186

Idem, p. 22.

187

Current registration figures are available on ECHA website (www.echa.europa.eu)

188

Study “Review of the European Chemicals Agency”, PwC, commissioned by the European
Commission, p. 41.

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is based on notifications submitted under Article 7(2) of REACH and on registration
dossiers.
In addition to the dissemination of basic data on chemicals, there are also publication
activities as part of ongoing REACH processes. The list of pre-registered substances
was made available at the end of 2008, in accordance with Article 28(4); see also
[Title 6]. Consultations through publication of testing proposals according to Article
40(2) are part of the dossier evaluation process; see also [Title 4]. The first CoRAP
was published on 29 February 2012 in accordance with Article 44(2), launching thefirst substance evaluations as further detailed in [Title 7]. Three recommendations forpriority substances to be included in Annex XIV were published so far under Article
58(4) and the publication of the candidate list itself is regularly updated in accordancewith Article 59(4); see also [Title 8]. Notices regarding the preparation of Annex XV
dossiers are published in accordance with Article 59(4) for authorisation, Annex XV
dossiers are published in accordance with Article 69(6) for restriction, as areproposals for harmonised classification and labelling under Article 37(4) of CLP189.
ECHA also publishes information to assist companies in the fulfilment of their
obligations under REACH. The results of the screening highlighted in [Title 6],
which aimed at gaining an overview of substances intended to be registered by the2010 deadline to enable planning of downstream users (DUs), were made available
before the 2010 registration deadline. Similarly, a list of substances identified forregistration by 31 May 2013, compiled based on responses from individual companies
to a survey, is available for consultation so as to allow planning of manufacturers,
importers and DUs towards this upcoming deadline. Finally, ECHA also publishes
the Registry of Intentions, the role of which is further discussed in [Titles 2, 5 and 9],
not only to facilitate timely preparation of interested parties for commenting in thelater stages of Annex XV dossier preparations, but also to avoid duplication of workand encourage coordination between Member States.
The Commission services welcome the progress made in ECHA’s dissemination
activities and encourage ECHA to continue finding new and improved ways to delivertransparency on chemicals information, so as to benefit all stakeholders – consumers,
the general public, industry and downstream users alike.
Policy about information published on ECHA's website
Publishing large amounts of information related to chemical substances entails a riskthat the publication of some of that information might be detrimental for thesubmitting company, as it is sensitive from a commercial or intellectual property
viewpoint. On the other hand, there is an interest for society as a whole, including
many companies that information is made publicly available. The inherent tension
between both interests, that of confidentiality and that of transparency, led to
discussions during the legislative process and resulted in the wording of Articles 118
and 119, as well as references to them in several other articles of REACH (e.g.,

189

EN

Before the adoption of CLP, the format for such proposals was outlined in Annex XV to REACH.
Accordingly, these proposals are also commonly referred to as “Annex XV dossiers”.

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Articles 64(2), 69(6) and 77(2)(e)). The application of Articles 118 and 119 hasraised various issues in practice.
First of all, several interpretation questions have been clarified: (1) The name of theregistrant can be published by ECHA, unless a justified confidentiality request has
been made and accepted, as the registrant’s name is contained in the safety data sheet(SDS) and thus falls within the remit of Article 119(2)(d). (2) ECHA, when dealing
with confidentiality requests regarding the registrant’s name, must duly take into
account any use made of the possibility to omit the part of the registration number
referring to the individual registrant in the SDS. (3) If a third party representative wasappointed pursuant to Article 4 of REACH, ECHA has no discretion to refuse
confidentiality requests regarding the registrant’s name. (4) Article 119(2)(b) requires
the publication of the sum of the individual tonnages for which registration dossiers
have been submitted, expressed as tonnage band. (5) Confidentiality requests
regarding tonnage data to be omitted from the publication of the total tonnage band
are to be assessed case-by-case, but are likely to succeed when the company
requesting confidentiality is the only registrant for a given substance or, depending on
the market structure, when there are a limited number of registrants.
Secondly, issues related to confidentiality of and access to information generated an
unexpectedly high workload for ECHA190. Rules needed to be defined to decide
which of the fields in a IUCLID dossier could be made available on the internet, andmanual intervention for publication was needed until March 2011, when automateddissemination was achieved191. By March 2011, ECHA had received some 1 300
confidentiality requests foreseen by Article 119(2), all of which ECHA aimed toassess by the end of 2012. ECHA’s Management Board adopted in 2008 a Decision
establishing remedies for reviewing rejections of confidentiality requests pursuant to
Article 118(3) of REACH192. In addition, a strategy was developed and implemented
to ensure that, in cases where the IUPAC name of the substance is kept confidential
under Article 119(2)(f) and (g), a suitable “public” name for the substance is provided
by the registrant to allow dissemination of substance information and consultation on
testing proposals.
Non-industry stakeholders are reported to perceive ECHA as too stringent when it
comes to releasing registrants names for dissemination purposes193. The Commission
services believe that as long as the clarification of the related interpretation questions
was pending, the approach taken by ECHA was the correct one under thecircumstances, and takes note of the fact that ECHA is now working in accordancewith the clarification provided. Non-industry stakeholders moreover are reported tobelieve that ECHA is too cautious when it comes to confidentiality of company data

EN

190

The Operation of REACH and CLP, European Chemicals Agency, 2011, p. 78.

191

Idem, p. 22.

192

Document MB/17/2008, amended by MB/17/2011 [available on www.echa.europa.eu]

193

Study “Review of the European Chemicals Agency”, PwC, p. 25 and 42; note that the cut-off for
the review period was and 2010, when interpretations questions (1) to (3) were not yet resolved.

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Informationand is not evaluating all confidentiality requests made due to resource constraints, but
the Commission services found no evidence substantiating this claim194. The
Commission services note ECHA’s intent to assess by the end of 2012 all 1 300
confidentiality requests received by March 2011.
The Commission services note that significant progress has been made andencourages ECHA to continue on its path of dissemination and transparency, while
taking due notice of the various interests to be balanced as laid down in Articles 118
and 119 of REACH.
Cooperation with OECD and third countries
International co-operation on REACH remains an important component of the EU's
work.
At the multilateral level, the main focus has been on strengthening cooperation with
the OECD195. The Commission, in association with the OECD, has further developed
the International Uniform ChemicaL Information Database (IUCLID) enabling theexchange of data on intrinsic and hazard properties of chemical substances. IUCLID
is the key data exchange tool under the OECD's Cooperative Chemical's Assessment
Programme. In addition, ECHA has cooperated closely on two major OECD projects,
namely the eChemPortal (Global Portal to Information on Chemical Substances) andthe QSAR Toolbox. The Portal now provides free public access to information on
chemical substances (including those published on ECHA's website). This is asignificant contribution to identify and make information on chemical properties
available to citizens. The QSAR Toolbox ensures that (Q)SAR technology is readily
accessible, transparent and less demanding in terms of infrastructure costs. It fills
gaps in the (eco)toxicity data needed for assessing the hazards of chemicals andprovides a common framework for the chemical industry (see also [Title 4]).
Cooperation with the OECD extends beyond project development to include also
participation in the implementation of the OECD Programme on High Production
Volume Chemicals.
At bilateral level, much investment has been made to increase the knowledge andunderstanding of REACH. Numerous meetings and workshops have been convened
within and outside the EU in an effort to ensure that candidate countries, potential
candidate countries and countries within the European Neighbourhood as well as third
countries are informed about REACH implementation. In addition, several visits areorganised annually in Brussels and Helsinki involving third country governments,
industry representatives and academia. REACH has also frequently been on theagenda of EU bilateral high-level meetings (Australia, Brazil, Canada, China, Japan,
India, Russia and USA), while every effort has also been made to address third
country concerns in other fora (notably WTO-TBT meetings).

EN

194

The Operation of REACH and CLP, European Chemicals Agency, 2011, p. 47.

195

Organisation for Economic Co-operation and Development.

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In recent years ECHA has further extended bilateral scientific and technicalcooperation. It signed Statements of Intent with Japan and the United States andMemorandums of Understanding with Canada and Australia.
Recommendations
12.1. ECHA is encouraged to continue finding new and improved ways to deliver transparency inchemicals information to the benefit of all stakeholders, while taking due notice of the various
interests to be balanced as laid down in Articles 118 and 119.
12.2. ECHA is encouraged to continue its fruitful cooperation with the OECD. ECHA is also invited toassess its general international activities taking into account its broader commitment and theadded value of its involvement and the international activities undertaken by the EU. Where
justified ECHA should consider reassigning the related resources to other commitments.

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ACHIEVING REACH OBJECTIVES
1.

HUMAN HEALTH AND ENVIRONMENT

1.1.

Background and Introduction

The EU industrial chemicals acquis started in 1967 and grew over the decades into asystem of Directives and Regulations. In the late 1990s it was recognised that existingchemicals legislation needed to be improved to address the growing concern for thenegative impacts chemicals had on human health and the environment. REACH wasadopted in 2006 replacing the previous regulatory system where one of the objectives
was to ensure a high level of protection of human health and the environment. The
appropriate implementation of its provisions are also the key elements of the EU'scommitment towards the implementation plan adopted at the 2002 World Summit on
Sustainable Development (WSSD) which aims to achieve that, by 2020, chemicals areproduced and used in ways that lead to minimisation of significant adverse effects onhuman health and the environment.
The REACH objective of Environment and Health Protection was to be achieved by
identifying suitable risk management measures based on a systematic collection or
generation of information on the hazards of chemicals, including testing. For
substances at or above 10 tonnes registrants must perform a chemical safetyassessment to check if additional risk reduction measures are necessary, beyond thoserequired by the hazard classification. Through registration the registrants confirm theimplementation of the necessary risk management measures and document theirdecisions. This comprehensive approach would not only improve the control where
this was needed, it would also identify those substances which needed no further oreven less controls. The REACH restrictions process was designed to control risks
which were not adequately controlled by measures already in place. The cumulative
result of industry and authority risk management measures are expected to reduce therisks to the environment and human health, including workers, consumers and thegeneral public via the environment. The authorisation process aims at assuring thatrisks from substances of very high concern (SVHCs) are properly controlled and thatthese substances are progressively replaced by less dangerous alternative substancesor technologies where these are economically and technically viable.
Protection of human health and the environment, including wildlife, should bebalanced against the use of animals in laboratory experiments. Therefore, REACH
provides for promoting the development of alternative methods for the assessment of
hazards of substances.
The health and environment objective of REACH is expected to be achieved through(1) better knowledge on the properties and uses of chemicals which results in better
safety and control measures, reducing exposure and hence, the negative impacts onhuman health and the environment; and (2) the use of less dangerous alternatives tothose substances of very high concern.

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Human Health and Environment

In 2003, the Commission carried out an impact assessment of its REACH proposal,
where potential health and environment benefits were assessed196.
First, it concluded that the main benefits of REACH arise from the application of
appropriate risk reduction measures – by industry in the first instance and mandated
by authorities in the second - enabled by a systematic generation of information on
hazards and uses of chemicals.
Second, the impact assessment provided an illustration of the potential scale of the
expected long term health benefits due to these risk reduction measures. It was
anticipated that the positive effects of REACH on public health would start to occur
10 years after the start of REACH implementation, i.e. effectively from 2018, andwould be fully observed after another 20 years, with total health benefits due to
REACH in the order of magnitude of € 50 billion over the 30 years period (after
discounting). The long-term benefits of REACH on the environment were estimatedby another study to be up to € 50 billion over the 25 years period (after
discounting)197. Notwithstanding the methodological difficulties the overall
conclusion was that the benefits of REACH far outweighed the costs.
The studies launched by the Commission in the framework of this review haveconfirmed that 5 years after the entry into force of REACH, it is still too early toquantify human health and environment benefits. This review therefore looks at initial
trends based on the examination of qualitative information and a representative set ofquantitative indicators198 + 199.
Assessment of the degree to which the health and environmental objectives of
REACH have been achieved started with the identification of the drivers of benefits
within REACH, where these are the set of legal provisions which are expected totrigger direct or indirect human health and/or environmental benefits; and theenhancers of these drivers, which are those provisions that help to realise the benefits
through support, control and enforcement and thus assist or ensure compliance withthe main obligations.
The Commission reviewed those key drivers which are already operational and ofparticular relevance to the generation of human health and environment benefits,
namely registration, requirements concerning information through the supply chain,authorisation and restrictions. The key enhancers of these benefit drivers (dossier

EN

196

Commission Staff Working Paper, [REACH] Extended Impact Assessment, 29.10.2003{COM(2003)644 final}.

197

Study “The impact of REACH on the environment and human health", DHI, commissioned by theEuropean Commission, September 2005.

198

Indicators reported on by the REACH Baseline Study: 5 Years Update, Progress Report IV, OkoInstitut, FoBiG, DHI and INERIS, commissioned by European Commission - Eurostat, December
2011.

199

Study “Assessment of health and environmental benefits of REACH” RPA, commissioned by theEuropean Commission, April 2012.

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evaluation, provision of guidance, inspections and enforcement activities) were also
looked at. It is also important to note that a number of key drivers were not consideredin this review as they have only just started or are still to come (e.g. registration
deadlines of 2013 and 2018, substance evaluation in 2012; first applications for
authorisation in 2012).

1.2.

Registration

Registration under REACH requires collection, generation and assessment of hazard
and exposure data, risk assessment and the identification of risk management
measures to ensure the safe use of chemicals. In particular, the following elements are
the key drivers for the control and reduction of harmful impacts on human health andthe environment:– The preparation of Chemical Safety Assessments (CSAs) for substances whichhave hazardous properties should create benefits through a reduction in unsafe use.
– The systematic collection of data and, where necessary, the generation of new(test) data should lead to improved information on the properties of chemicals,
improved reliability of classifications and thus improved information on safe use
and handling. It should also improve the information base for the implementationand enforcement of other legislation.
– The requirement to carry out a PBT assessment200 as part of the CSA should help
ensure that substances are identified as potential SVHC and can be made subject tomore detailed evaluation, authorisation or restriction.
– The requirement to register substances will create benefits for human health andthe environment where a substance is no longer supported by registrants due to its
hazardous properties as well as the availability of suitable alternatives, and istherefore withdrawn from the market.
In addition, the evaluation of dossiers should act as an enhancer of benefits if it helps
registrants to learn how to improve their registration dossiers. Guidance should also
act as an enhancer by providing tools for assessing safe use. Similarly, inspection andenforcement should act as enhancers by ensuring there is an incentive to comply withthe registration provisions.
From work carried out specifically for the REACH benefits study201 on a sub-set of 71
substances being reviewed as part of the REACH baseline study, it is clear that the
information being generated from REACH is resulting in changes in classification,with the majority of these being more restrictive classifications. This is particularly

EN

200

Assessment of persistency, bioaccumulation and toxicity of substances.

201

Study “Assessment of health and environmental benefits of REACH”. RPA, commissioned by theEuropean Commission, April 2012.

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noticeable for endpoints such as acute toxicity, sensitisation, reproductive toxicity andaquatic toxicity. Overall, the percentages classified after registration increased acrossall of the endpoints being considered. This suggests that classifications are becoming
more reliable as more and improved information on substances properties is generated
and as registrants harmonise classifications. These findings are important asclassifications drive the need for the development of exposure scenarios within the
CSA and, in response to these, for registrants to put forward recommended risk
management measures in their extended safety data sheets (eSDS). There are someoutstanding issues, such as the continued existence of multiple self-classifications
which is giving rise to problems for formulators, but these should reduce over time as
more substances go through registration.
With respect to the duty to prepare a CSA, the findings202 confirm that this should
lead to safer use as new or more stringent risk management measures than thosecurrently in place are being recommended by registrants to their downstream supply
chains. This should lead to benefits for workers, to the environment (through reduced
emissions) and to the general public through reductions in environmental exposures,
particularly as the substances produced and/or imported in less than 1000 tonnes per
year go through registration.
With regard to substance withdrawal, there is evidence that substances have been
“dropped” from the market or otherwise not registered due to their properties (inparticular CMRs203) and/or the potential costs of supporting them throughauthorisation as well as registration204. It is also clear though that substancewithdrawal may be taking place as part of the rationalisation of product portfolios.
The exact extent to which substances that have been withdrawn are replaced by a lesshazardous alternative is not known at this stage of REACH implementation but itwould be worth investigating in future research in order to avoid unwanted
withdrawal of substances that would lead to no additional benefits to human healthand the environment.
There is a need for all actors to increase efforts to improve the quality of registration
dossiers. The quality of information submitted by industry in registration dossiers has
indeed been identified by ECHA205 as being of concern, leading to many dossiers
being found non-compliant or whose quality should be improved, as already describedin [Title 6 of Part I]. An analysis of a sub-set of registered substances also suggeststhat registrants have not fully responded to the need to provide a clear assessment of
PBT and vPvB properties. A preliminary conclusion is that bringing the registration
dossiers already submitted into compliance is a priority. An appropriate scrutiny islikely to become even more important in the next registration phases, as in the past the
202

EN

Idem.

203

Carcinogenic, mutagenic, toxic for reproduction.

204

Study “Assessment of health and environmental benefits of REACH”. RPA, commissioned by theEuropean Commission, April 2012, .

205

Evaluation Under REACH, Progress Report 2011, European Chemicals Agency, 2012

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lower volume substances had generally less data available on their properties thanthose registered in the first phase. It is therefore evident that without increasing
industry efforts with respect to the fulfilment of the REACH registration
requirements, as well as ECHA and Member States not ensuring the compliance withlegal requirement through the dossier evaluation and the enforcement inspections, thefulfilment of the health and environmental objectives of REACH will be jeopardised.
The Commission services in liaison with ECHA will gather further practical evidence
on how to provide the best possible basis for the identification of substances anddetermination of "sameness". This will take into account experience gained from thecurrent registration dossiers. Once there is a solid evidence basis the Commission may
come forward with a proposal which could be legal measures, such as for instance
implementing legislation on the identity of substances, in order to improve thecompliance with REACH requirements.
Finally, it has to be noticed that the monitoring of REACH performance carried out by
Eurostat206 relating to the quality of the data publically available for chemicals
assessment, for the substances already registered, shows a marked increase in thequality of available data if compared with the pre-REACH situation.
1.3.

Requirements concerning information in the supply chain

Effective supply chain communication is essential for the functioning of REACH bothin terms of registrants relying on information for the assessment of risks and ofdownstream users relying on good information to implement safe use. Manufacturers
and importers of hazardous substances are required to provide hazard, exposure andrisk management information to their recipients, primarily via the eSDSs. In addition,
suppliers of articles containing chemicals identified as SVHCs have obligations(under Article 33) to provide information down the supply chain and to consumers, toenable the safe use of those articles.
For these provisions, the health and environmental benefits are generated throughthree main mechanisms:– The communication of information through SDS and eSDS creates benefits
because new information is passed to downstream users enabling them to checktheir handling and use of chemicals.
– The requirement to communicate information upstream on operating conditions orrisk management measures (RMM) creates benefits because new and appropriate
RMMs are identified and included in updated safety assessments and the overall
quality of SDS is improved.
– The need for article producers to communicate the presence of a SVHC on thecandidate list in an article leads to benefits by helping to ensure the safe use ofarticles, triggering requests from retailers for the phase-out of SVHCs in articles,

206

EN

REACH Baseline Study: 5 years update. Contribution to the Report of the Commission, European
Commission – Eurostat, 2012.

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and enabling consumers to take the presence of an SVHC into account in theirpurchasing decisions.
The findings of the Commission services confirm that the new obligation onregistrants to set out safe operating conditions (OCs) and RMMs as well as to provide
such information to downstream users have already generated benefits during this firstphase but is likely to be even more important for those substances about which there
is currently less knowledge.
Additionally, the monitoring activities conducted by Eurostat on reference substances
show a marked decrease in the nominal risk associated with those already registered,
due largely to REACH207.
With respect to the quality and value of SDS and eSDS, the findings are twofold. The
quality of SDSs have improved because the information on classification (and hencelabelling) contained within them is regarded as more reliable. In addition, theinformation being provided on DNELs208 is useful for workplace safety assessments(as a substitute for an OEL209) and can contribute to better targeted RMMs. However,there are problems with regard to the content and format of eSDS as currently being
provided in supply chains.
Formulators have an essential role in supply chain communication with regard to theinformation on safe use, because they have to provide their safety data sheet in a waythat it gives orientation to the downstream user on what to actually do. It has beenreported that both suppliers of substances and formulators of chemical mixturescompile large amounts of information in their eSDS which sometimes leads toconfusion. Hence, there is a need for ECHA, in cooperation with industry, to progress
their work on CHESAR210 and derive from that the core information structure forcommunication on uses in order to facilitate respective supply chain communication.
Structures such as CHESAR should be used by industry to develop their softwaretools to provide safety data sheets. There is also a need for a revised format of the
exposure scenario for supply chain communication which should be provided in astandardised IT format.
Industry continues working on standard phrases for conditions of use and RMMs.
However, it appears that more commitment is needed. Downstream users should be
encouraged to provide information on conditions of use in ECHA information
structure in a targeted way.
At the same time, players at the bottom of the supply chain, such as article producers,
have still already benefited from an increased level of knowledge on the properties

207

EN

Idem

208

Derived No-effect Levels

209

Occupational Exposure Level

210

CHEmical Safety Assessment and Reporting tool

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and/or the possible uses of chemical substances. This can only have been the result of
supply chain communication requirements. The same is true for end-users, who
confirmed through the surveys conducted under this review that REACH has
increased their level of knowledge on the properties and/or the possible uses ofchemicals.
With respect to communication on SVHCs through the supply chain, substitution
would be promoted through the “announcement effect” associated with the candidate
listing of SVHC and the duty to provide information on SVHCs in articles containedin concentrations above 0.1% to users of articles. Indeed, the candidate listing isleading to an early action towards substitution by formulators and demands for
substitution within their supply chains by article producers. Thus, it could be expectedthat the use of SVHCs will gradually reduce, particularly in consumer goods.
Article producers and retailers are putting in place the necessary information systems
to manage the necessary supply chain communication and in particular to undertakethe necessary compliance checks through product and supplier inspections. It is
important that these efforts are intensified to avoid supply disruptions as the candidate
list grows in size.
One of the problems identified relates to the 0.1% concentration threshold for SVHC
present in articles. These are addressed in greater details in [Title 5] of Part I.

1.4.

Authorisation and restrictions

The authorisation provisions within REACH are aimed at ensuring that risks from
SVHCs are properly controlled, and that these substances are progressively replacedby suitable alternative substances or technologies where these are economically andtechnically viable. The identification of SVHCs is a hazard based concept, although
the prioritisation of SVHCs does take into account factors such as production volumes
and whether there is wide-dispersive use of the substance as proxies for potential
risks.
REACH also includes a separate provision allowing restrictions on the manufacture(or import), placing on the market and/or on specific uses of either a substance,
mixtures and/or articles (subject to some exemptions), where these can be shown topose an unacceptable risk to human health or the environment that should be
addressed on an EU-wide basis. The restriction provisions are not dissimilar to thoseestablished under the earlier combination of Regulation (EC) No 793/93 and Directive
76/769/EEC. However, the restriction process under REACH is expected to speed up
the time taken for measures to be adopted and implemented as well as to allow for
more targeted assessments.
At the time of writing, 82 substances had been entered onto the candidate list, with 36
substances prioritised for authorisation. From the information obtained in this review,
it is clear that Annex XIV and candidate listings are having their desired effect:

EN

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substances placed on the lists are being withdrawn from use and downstream users are
moving to substitutes where possible211. Thus, this process is beginning to deliver
benefits associated with removals of SVHCs from use in the EU. As anticipated,
substance withdrawal is taking place because some manufacturers and importers are
reluctant to register a substance that may be subject to Authorisation, which would
lead to further costs associated with having to make applications for continued use.
Although an important increase in the number of substances included in the candidate
list in 2011 and 2012 has been observed, there is still a need for more effort to achieve
the target proposed by the Commission. This is that all relevant currently known
SVHCs will be included in the candidate list and so contribute to the 2002 WSSD
goal that, by 2020, chemicals are produced and used in ways that do not lead tosignificant adverse effects on human health and the environment. This suggests that
inadequate resources are provided to maintain the candidate list process. The
Commission is striving to mobilise efforts in Member States to achieve the long-term
objective as well as a mid-term target of 136 SVHC on the candidate list by end of
2012.
Achieving these targets should also be seen in the context of the Roadmap to a
resource-efficient Europe which was adopted by the Commission on 20 September
2011212. The roadmap sets an agenda for competitiveness and growth based on using
fewer resources when we produce and consume goods and creating business and job
opportunities from activities such as recycling, better product design, materials
substitution and eco-engineering. Phasing out and substituting dangerous chemicals
with safer alternatives can help protect key resources like soil and water, and makeothers, like materials, safer, easier and less costly to recycle and reuse.
On the other hand, a need for increased transparency in the judgements underlying thedecision-making of Member States and the Commission when deciding which
chemicals should have dossiers prepared and then which should be the ones
prioritised has been reported. Further explanation and justification could, therefore,
help address this issue and build understanding and trust between the regulators andthe regulated.
Moreover, there have been concerns reported that potential substitutes to SVHC listed
already on the candidate list may not necessarily be better from a human health orenvironmental perspective. In this respect, groups of substances with similar
properties should be considered together when assessing substances for entry onto thecandidate list to avoid downstream users of these chemicals shifting to unsuitable
alternatives. There may also be a role here for ECHA in undertaking work to help
identify substitutes, following listing or for other types of support to be given tosmaller companies.

EN

211

Study “Assessment of health and environmental benefits of REACH”. RPA, commissioned by theEuropean Commission, April 2012.

212

Communication from the Commission […] Roadmap to a Resource Efficient Europe, European
Commission, 20.9.2011, {SEC(2011) 1067 final},

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Under REACH, four dossiers concerning risks to human health and the environment
were proposed by Member States, Norway and ECHA (dimethylfumarate, lead in
jewellery, mercury in measuring devices and phenylmercury compounds) and theCommission will adopt restriction measures and amend Annex XVII.
Other Annex XV dossier for restriction proposals have been submitted to ECHA,
mainly targeting human health concerns. These target the use of chromium (notably
an allergic and irritant substance) in leather articles and the use of phthalates in indoor
applications and some articles.
Particular attention continues to be paid to substances that are carcinogenic,
mutagenic and toxic for reproduction (CMR). As under the previous legal framework,
the Commission adopted Regulation (EU) No 109/2012 (under Article 68(2)) whichbans the sale to the general public of substances that were newly classified under CLP
as CMR category 1A or 1B and of mixtures containing them.
The restriction procedure provides a structured and transparent procedure to tackle
unacceptable risks to human health and environment which need to be addressed on
an EU-wide basis. The initiation of the process is a shared responsibility among
Commission and Member States, and further efforts should be undertaken toencourage initiatives in this area with the view to maximise the potential benefits ofthis measure.
1.5.

Conclusions

As detailed in the chapter above, some progress towards meeting the human healthand environment objectives of REACH is materialising. This trend is expected toaccelerate as the remaining key benefit drivers and their associated enhancers become
operational, conditional on the legislation being appropriately applied and adequately
enforced.
On that basis, the Commission services conclude that:– Increased information is resulting in changes in classification, with the majority
becoming more restrictive. This is valid across all hazard classes, but particularly
noticeable for acute toxicity, sensitisation, reproductive toxicity and aquatic
toxicity.
– The overall quality of available data for the chemical assessment of registeredsubstances has generally increased if compared with the pre-REACH situation.
– Increased information passed along the supply chain and the obligation to set out
safe operating conditions and risk management measures is resulting in improved
SDS, making them better risk management tools.
– Increased information in the supply chain has benefited end-users, such as article
producers.
– Increased obligations on SVHCs through the candidate listing and authorisation
provisions has in some cases led to their withdrawal.

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The Commission services also identified a number of key shortcomings hindering theachievement of the health and environment objectives and in particular the
improvements set out above. These can be summarised as follow:– ECHA identifies the quality of information submitted by industry in registration
dossiers as being of concern leading to many dossiers found non-compliant.
– Analysis carried out for the human health and environment study on selected
registration dossiers suggests that registrants need to improve their assessment of
PBT and vPvB properties.
– Industry indicates problems with regard to the content and format of the eSDS.
Although it is too soon to have a complete picture of the extent of the benefits
generated by the first implementation phase of REACH, the data collected so far
verifies the general hypothesis that REACH will deliver human health andenvironmental benefits. Nevertheless, there are areas where improvements should bemade if the expected benefits are to materialise. The Commission services havedeveloped the following recommendations on actions or measures that could be taken
to improve the degree to which REACH is delivering human health andenvironmental benefits.
Recommendations
I.1.
I.2

I.3

EN

The Industry should improve the quality of dossiers to ensure that the information they submit
adequately documents how they ensure the safety of their substances.
Based on evidence gathered by ECHA relating to the identification of substances anddetermination of "sameness", the Commission services will consider options to improve thesituation, including legal measures.
In order to progress towards achieving the WSSD goal that by 2020 chemicals are produced
and used in ways that lead to minimisation of significant adverse effects on human health andthe environment, identification and phasing out of SVHCs as well as restrictions should both beencouraged.

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2.

Single Market, Competitiveness and Innovation

SINGLE MARKET, COMPETITIVENESS AND INNOVATIONREACH regulation affects all sectors of the economy where chemical substances areproduced or used. Businesses that manufacture or import (from outside the EU) 1
tonne or more of any given substance each year (with limited exemptions) are subject
to registration. Any business using chemicals will have to apply appropriate risk
management measures for any use of the substance and respond to other actors onother aspects of REACH. Whilst acknowledging the wide and varied impact across all
the economy, the Commission services have decided to focus an analysis on one
sector which will be affected first and by all processes of REACH – the chemicals
sector as a representative for all roles and types of impacts.

2.1.

Background
The EU chemical industry performed well during the past decade, but its
global presence decreased from ~30% to ~21% of the world’s chemicals
market share as a result of vey high and continuous growth rates in emerging
economies.

The chemical industry is one of the largest EU industrial sectors and an importantsource of direct and indirect employment in many regions of the EU. In 2009, the EU
chemical industry comprised some 29 000 enterprises that employed around 1.2
million employees representing 4% of the total employment in the EU manufacturingsector. 96% of the companies in the sector are SMEs – 61% with less than nine
employees. They account for 28% of sales and 35% of employment of the sector.
With a total production value of € 491 billion in 2011, the chemical industry's
contribution to the EU gross domestic product amounted to 1.1% representing about
7% of the EU manufacturing sector total.
Between 2000 and 2010 the chemical industry production experienced an average
growth rate of 0.7% – slightly higher than the 0.2% average growth rate for total EU
manufacturing. The economic crisis of 2008 and 2009 has sharply decreased theoutput to the levels last seen a decade ago but it recovered vastly in 2010 and with agreater pace then the rest of the manufacturing sector.
In 2000 (when the preparation of the White Paper that led to REACH began), the EU
was regulating a market of close to 30% of global chemicals production. Together
with NAFTA and Japan, where environmental and industrial policies also are closely
observed and mirrored – these jurisdictions regulated 70% of global chemicals market
sales.
A decade later, the global economic outlook has changed dramatically. The centre ofgravity in world manufacturing and chemical industry alike has shifted eastward: in
2010, the Asian market was double that of the EU, which share of global sales
decreased to ~20%, despite growth in absolute numbers. REACH as a regulatorymodel has consequently a somewhat reduced impact worldwide, even though the

EN

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generated data and technology changes remain important for chemical safety also
outside the EU. Also, some emerging economies were inspired by the REACH
approach and are adopting similar regimes213.
Figure 3. World sales of chemicals by dominant markets

30

world sales %

2000

2010

20

10

0

EU

NAFTA

Japan

China

Others

Source: CEFIC: Facts and Figures 2011, www.cefic.eu

The position of the EU chemical industry seems to be very solid, but when coupledwith the changing dynamics of global competitiveness over the course of the past
decade, it is important to review how the economic objectives of REACH have been
met so far.

2.2.

Single market
REACH has increased the harmonisation of the EU chemicals market, andtherefore contributed to increased intra-EU trade, but in a rather limited scaleat this stage as other important barriers still exist.

The single market, with 500 million consumers, 220 million workers and 20 million
entrepreneurs, is a key instrument in achieving a competitive industrial EU. The
single market has been one of the main motors of economic growth in the EU over thelast 20 years. It has provided EU industry with considerable reductions in cross-border
trading costs, increased competition, and provided considerable economies of scaleand scope from the availability of an EU-wide market. However, as the market isconstantly evolving, new barriers emerge and add up to the already identified barriers
as well as to those yet to be discovered.

213

EN

The South Korean Ministry of the Environment conducted public consultations on a draft “Act on
the Registration and Evaluation of Chemicals”. The new act will overhaul the current Toxic
Chemicals Control Act and will regulate both new and existing substances. In many dimensions is
inspired by REACH and is often referred to as 'Korea REACH'. The legislation is expected tocome into force in 2013.

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REACH was designed to attempt reducing the number of barriers for intra-EU tradeof chemicals and provide the Commission with tools preventing future fragmentation.
Recital (2) provides that “[t]he efficient functioning of the internal market for
substances can be achieved only if requirements for substances do not differ
significantly from Member State to Member State".
REACH also provides a set of unified tools for EU-wide distribution of chemical
products:– a single registration process with unified guidelines and unified fee structure,
implemented by a single authority (ECHA);– a single and directly applicable list of restrictions on marketing and use; and– a single list of substances subject to authorisation.
Complying with these administrative requirements (which are necessary for marketingin a company-based market), shall give, in the Commission's intent, an instantadministrative green light to distribute EU-wide – therefore being completelytransparent with regard to the single market.
Figure 4. Composition of EU chemical sector sales by destination
600

billion euro

500
400

Extra-EU300

Intra-EU

200

Domestic

100
0

1995

1998

2001

2004

2007

2010

Source: Eurostat and Cefic Chemdata International

This can therefore be seen as a success of REACH. The data on intra-EU trade show
an uninterrupted increase of the intra-EU trade as a share of the total EU market size
over the past 15 years. Although the direct impact of the introduction of REACH
cannot be detectable yet, the fact that intra-EU trade has been growing faster than theoverall rate of the manufacturing industry already gives a solid reassurance that
REACH has met its expectation in preventing regulatory fragmentation.

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To verify this claim, companies were asked a question in a survey214 on their opinionof the role of REACH in entering other markets within the EU. About 10% answeredthat it already was (or would be in the future) a positive factor – which is a non-trivial
share, given the relatively early stage in the implementation of REACH.
However, the exact mechanisms by which REACH impacts intra-EU trade are notevident to companies at this stage. For example, 91.5% of companies' respondents
could not identify any particular contribution of REACH in relation to trade. Thismight be explained by the fact that companies answered this question only on thebasis of their direct experience with the registration process and that registration did
not unify any pre-existing fragmented process (with regard to phase-in substances215),
as it rather established a unique and new process. Its contribution should thus beperceived as a measure to prevent market fragmentation in anticipation of possible
future similar schemes introduced by various legislations within the EU.
Furthermore, some important harmonisations happened on less visible levels of
implementation. Enforcement is key for the credibility of any legal framework. It
fosters an equal level playing field for all economic operators and in all EU Member
States. Therefore, it enhances the single market and increases the credibility of the
responsible industry. The establishment of the Forum has allowed enforcement
authorities to intensify their cooperation, as well as exchange best practices andmutual benchmarking. Transparency in their mutual performance via reports and joint
projects established a sense of common goal and spurred creative imitation.
In addition, Article 122 obliges Competent Authorities (CAs) to cooperate with eachother in the performance of all of their tasks under REACH. This happens, forinstance, through the work of the Commission expert groups (e.g. CARACAL216) andthe ECHA Committees. All of these platforms have facilitated information flow about
new concerns in Member States, and helped disseminating best identified approaches
to assess risks and select the most appropriate risk measure. In result, the risk ofnational risk management measures being sought by Member States was greatly
reduced, but unfortunately, not completely eliminated217.
Finally, some important harmonisation impacts come from the restrictions process –which only recently got operational by having the first case of a substance restriction
fully handled under REACH218. Restrictions are a known and well-recognised risk

EN

214

CSES was commissioned by the Commission to conduct an industry survey with the aim to study
industry impacts of REACH. More than 1 500 companies participated in the survey which ran overthe period of July to September 2011.

215

It did establish an improvement for new substances, but the vast majority of the value of thechemicals market constitute phase-in substances.

216

Competent Authorities for REACH and CLP, see [Title 11] of Part I.

217

For instance, in the field of unified approach to the enforcement of Article 33.

218

Regulation (EU) No 412/2012 of 15 May 2012 amending Annex XVII to Regulation (EC) No
1907/2006 of the European Parliament and of the Council on the Registration, Evaluation,
Authorisation and Restriction of Chemicals (REACH), OJ L 128/1, 16.5.2012, p.1.

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management tool. They provide authorities a great flexibility as they may target
substances, specific uses (e.g. in articles), concentration limits, etc. For this reason
they were commonly used by the REACH predecessor Directive 76/769/EEC andnumerous national measures. Harmonisation potential within this domain was
significant. Some solutions were “low hanging fruit” like the direct application of
REACH which reduced the timelag resulting from transposition into national law andeliminated the risk of going beyond that which was legally required. Others required
more elaboration, like the development of common guidance for identification of risks
to ensure that all concerns of Member States’ priorities (which are variable) areaddressed homogeneously.
In conclusion, REACH is leading to harmonisation of the internal market. However,
harmonisation may be further pursued by removing remaining pre-REACH national
measures, differences in administrative cultures, and the enforcement of REACH.

2.3.

Competitiveness
There are signs that the functioning of the market is improving, but in the
short term, the competitiveness of the EU chemical industry has been affectedby the costs of registration which have been higher then expected.

Competitiveness of the single market
The concepts of competitiveness and competitive advantage have traditionally been
discussed on a firm- or industry-base. However, it may also be applied to the“market”, in which case it relates to the efficiency of the given market in allocating
resources. In the literature219, the ideal market is characterised by a very large numberof buyers and sellers, equal distribution of information, lack of barriers for enteringand exiting the market etc. REACH has affected some of these parameters, which are
discussed in more detail below, such as (a) number of market players, (b) distributionof information and (c) barriers to market entry.
With regard to number of market players, the Commission has anticipated an effectof concentration and analysed its potential costs in the original impact assessment. It
was considered to give rise to more than half of all REACH-related costs (€ 2.8-3.6
billion)220. The survey found confirmation of this development. Among suppliers,
around 25% of manufacturers and importers of chemicals stated that they decided toremove one or more substances from the market (usually representing a small share of
their portfolio). Considering the reasons for the withdrawal of substances, by far themost common reason – according to the survey results – appears to be the registration
costs that make the overall trading of the substance unprofitable.

EN

219

Stigler J. G. (1987), "competition," The New Palgrave: A Dictionary of Economics, Ist edition,
vol. 3, p. 531–46.

220

J. Canton, CH. Allen, A Microeconomic Model to Assess the Economic Impacts of the EU's New
Chemicals Policy, DG Enterprise, 2003

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The survey suggests a rather wide variation in terms of the average total costs per
registration (per substance and per registrant), with the most typical value fallingwithin the range of € 50 000-100 000 and 70% in the broader range of € 25 000-€
250 000. For complex registration dossiers (for instance for substances with numerous
uses or forms) the registration costs may go beyond € 1 million221. Analysis of thedrivers of the registration costs reveals that ECHA fees often represent 50% or moreof the total costs, especially in the case of simpler substances and smaller firms. In thecase of more complicated substances, data collection, costs related to SIEF andconsortia (including management and other fees) are the main cost elements, often
exceeding € 100 000.
In global terms, the original impact assessment, and subsequent more detailed
calculations222, have tended to anticipate a cost for the first registration deadline(which passed in November 2010) of around € 1.15 billion (when recalculated into
2011 prices) for the industry. The results of the survey provide an estimate of theeffective cost of that phase with a total of around € 2.1 billion. A large part of thedifference comes from firms reporting also on the sums paid to data holders for accessto existing data. These costs were not considered in the impact assessment as they do
not represent an additional cost from the perspective of society. Nonetheless, as
existing data represented 50% of all data collected in the first registration period (seeFigure 1 in [Sub-Title 3.2] of Part I) this needs to be considered as an important cost
factor from the registrant’s perspective. Another main reason behind the difference issignificantly lower use of (Q)SAR than anticipated as a mean to lower the cost of
acquiring new data.
The Substance Information Exchange Forums (SIEFs) have helped in reducing thecosts – as confirmed by 65% of surveyed companies in the survey - even though avariety of problematic aspects affecting the further realisation of cost savings havebeen identified. E.g., communication and coordination problems were mentioned by
75% of surveyed companies. At the same time, ways of improving communication
have also been identified, e.g. by establishing consortia (30% of consortia members
have positive view of the SIEF functioning, as compared to only 13% of firms who do
not participate in any consortia).
A more crucial point concerns the cost of letters of access223 that often represent morethan 50% of the total costs of the registration and, as revealed by the survey, are often
seen by SMEs as a tool used by large firms to push small competitors out of themarket. In addition the survey analysis suggests that the main problem is the absenceof a transparent approach in presenting the various cost elements and how the price ofletters of access is set. It should be also noted that costs of letters are usually fixed and

EN

221

Study “The REACH contribution to the development, commercialization and uptake of products ofemerging technologies". Gaia, commissioned by the European Commission.

222

Commission Staff Working Paper, [REACH] Extended Impact Assessment, COM(2003)644 final,
29.10.2003.

223

A letter of access is a document issued by a lead registrant (or consortium) granting a company theright to refer to the registration dossier as a member registrant.

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independent of effective volume – in effect causing smaller companies to pay more
per unit of trade. This issue was also brought up in the Directors’ Contact Group(DCG) and some solutions relating to transparency were already suggested to theindustry. Other options relating to the variation of prices of data sharing based on theindicative tonnage band of individual companies remain to be explored.
As for the impact on actors down the supply chain, the analysis of individualcomments to the survey suggests that “experience of withdrawal” usually does notmean complete loss of access to the specific substance, but rather only a switch toanother supplier – be it within the EU or outside the EU. Such a switch must have had
an impact on the costs of supplies because under normal circumstances one has toassume that the previous supplier was the most economic one. For those substancesthat are no longer offered on the market at all, a number of downstream users (DUs)
associations reassured that they had been in the last stages of the substance's
economic lifecycle, and had been expected to be withdrawn regardless of REACH.
For those substances, REACH has only accelerated a natural trend.
For the complete withdrawals, the most common response of firms was to identify
substitutes (53% suggested it as the most common response). Only a small share of
DUs (close to 12%) stated that they had decided to register the relevant substancethemselves, despite the fact that switching to other suppliers can be troublesome. In
the survey, companies referred to substantial resources dedicated to identifying
alternative suppliers of substances and to confirming continued supply in the future.
For certain downstream industries (like aerospace or defence) alternatives need topass internal certification procedures to guarantee performance.
Nevertheless, the general picture is that so far the complete withdrawal of substances
is not a widespread phenomenon and that there are only limited cases where this has
been problematic for firms in terms of their access to essential input substances.
Furthermore, as already mentioned, many of these withdrawn substances weretowards the end of their economic life-cycle and firms were already preparing fortheir phase-out. More important consequences relate to partial withdrawal, which
results in increased concentration and decreased competition among suppliers.
With regard to the distribution of information, the main contribution from REACH
is the provision of data from the chemical safety reports (CSR) via the extended (orstandard) safety data sheets (eSDS). Another contribution comes from ECHA’s publicdissemination of information on substances' intrinsic properties, hazard profiles,
classification and labelling, safe uses and risk management measures associated withthem. On 16 March 2012 ECHA published information on 4'326 substances224. It willtake some time until all actors in the supply chain learn about this new source of
information and take it into account in their market decisions.
However, the flow of information among the chemicals market players has been also
affected by the side-effects of formation of SIEFs and of working lists of substances
pending assessment of the need for future risk management measures.

224

EN

The Operation of REACH and CLP, European Chemicals Agency, 2011, p. 22.

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Through an abuse of the tools available to pre-registering companies, a certain
number of them gained access to previously unavailable platforms to advertise theirservices by using the functionality of SIEF Formation Facilitators, which inconsequence blocked genuine potential lead registrants from taking over the role.
Moreover, the function of the lead registrants has created opportunities to retrieve
information from the market about the structure of the competition. This does not
relate to systematic breach of intellectual property or confidential information (forwhich we have found no evidence whatsoever), but to the fact that participation in a
SIEF provides important business information about the offer and the volume offeredwithin the supply chain. Especially companies who act as lead registrant for a large
number of substances (which constitute their core business) received an
unprecedented access to reliable information about the composition and structure of
their competition.
Finally, the working lists of substances entering the assessment for possible risk
management measures (candidate list, ECHA’s Registry of Intentions) have sent
multiple signals to the market. The intent was to increase the transparency andpredictability of REACH risk management processes, but they have also resulted in ademand to avoid these substances even before their risks have been effectively
assessed by the regulators. This goes beyond legal obligations and has already had atangible impact on the market; it is more a question of psychology rather thanassessment of risks by end-users or customers.
Concerning the barriers for entering the market, the impacts of REACH can beboth positive and negative225. Positive: by the harmonisation efforts, the costs ofexpanding into other EU markets were reduced. Negative: by costs of registration; fornew (and existing) supply-side companies, registration will be mandatory as of a 1
tonne of annual manufacturing or import volume, subject to transition deadlines226.
However, REACH does not seem to constitute a barrier to enter the market forexisting substances. It is rather a potential expansion barrier, since for companies whoare close to the threshold, an analysis of the marginal cost of registration has to beconsidered before companies decide to expand above the threshold227. In case of fast
expansions, the decision may be obvious. But for slow and gradual expansions in lowmargin markets, the registration requirement becomes a trap effectively preventing
firms from continuing their gradual growth as they lack capacity to build a newcustomer base large enough to pass the range of uneconomic volume. The survey

EN

225

The expectations for reducing barriers for expanding to other markets have been already discussed
above [Sub-Title 2.2].

226

Where meeting criteria of Art. 3(20) of REACH.

227

As already mentioned - a typical individual registration through a SIEF membership costs between€ 25 000 euro to € 250 000 euro. In addition, other REACH obligations imply additional work forthe company staff. For SMEs it usually requires 0.5-1 full time equivalent for REACH related
activities. Larger firms have usually established dedicated units with a typical occupancy of 1 to 5
persons.

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revealed that companies who have already found themselves close to the registrationthreshold have opted to downsize rather than expand (which in case of year 2010
could anyway be rather difficult to achieve given the economic crisis) and therefore
delay registration expenses228.
External competitiveness of EU chemical industry
The EU chemical industry has been performing well in the last decade, especially incomparison to other traditional global competitors. Particularly well-performing are
sub-sectors such as specialty chemicals and consumer chemicals which increased theirtrade surplus with most of the EU’s main trading partners229. These two sub-sectors
in 2010 accounted for 70% of the extra-EU chemicals trade surplus. Basic inorganics
experienced a trade deficit of € 1.9 billion – but this is the only sector with a trade
deficit since 1994.
However, there are a number of indicators suggesting that the EU chemical sector isunder increased pressure. Compared to 1999, the EU's share of world chemical sales
has declined by 11 percentage points (from 32.1% in 1999 to 20.9% in 2010). Whilestill in a strong position, the EU has lost its top ranking to Asia, mainly due to the riseof China and of the Middle East.
It appears, therefore, that the EU chemical industry is doing much better ininnovation-driven sub-sectors (e.g. specialty products) than in more cost-orientatedsub-sectors (e.g. commodity products) or sub-sectors for which important downstream
industries have moved a substantial proportion of their activities out of the EU. In
consequence, the competitiveness of the chemical industry is very much dependent on
its capacity to conduct research and development, commercialise the results andensure rapid uptake of innovation results230, as discussed in more detail in [Sub-Title
2.4].

228

End of November 2010 the registration deadline passed for manufacturers and importers placing
on the market 1000 tonnes or more of any substance per year. Those who scaled below 1 000
tonnes will have to undergo the registration process by May 2013 when the deadline passes for all
manufacturers who place on the market 100 tonnes or more per year.
The Commission has also learned that companies from countries outside the EU could have set up
multiple new legal entities within the EU, each of which can take up less than 1 000 tonnes tocircumvent registration requirements.

EN

229

Facts and Figures 2011, CEFIC, [http://www.cefic.org]

230

A. Stajano, Research, Quality, Competitiveness. EU Technology Policy for the Knowledge-based
Society, 2009.

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150
Extra-EU exports

120

Extra EU imports

90
60
30

2010

2006

2002

1998

1994

0
1990

Industry growth (cumulative %)Figure 5. Export / import balance of EU chemical industry in the past decade.

Source: CEFIC, Facts and Figures 2011, www.cefic.org

The positive contribution of REACH to the global position of EU industry lies invarious aspects like better information or well-documented sources of supplies. The
registration and authorisation requirements, and resulting reallocation of R&D231 as
well as, in some fields, impacts on marginal cost structure232 can also be seen as anegative factor for some companies.
Further improvement in the information flow within the value chains will expand EU
industry's competitive advantage with regard to timely response to changing market
needs. The development of more advanced supply chain management practices –including the use of IT tools – has been a response to REACH requirements that canbring important productivity results in the future.
However, at this stage, these benefits are generally outweighed by the costs andchallenges of supply chain communication. For the majority of the survey respondents(close to 70%) REACH has increased the costs of managing information exchange
along the supply chain. Significant human resources and time are dedicated to thedevelopment, handling and extraction of the relevant information included in the SDS
or, if applicable, in the eSDS. The typical costs for the preparation of an SDS isaround € 200 and over € 500 for an eSDS, but can reach up to € 2 500 in the case oftranslations in all EU languages. IT systems are also often purchased by firms to
support the handling of information with costs ranging from a few thousands to morethan a million euro depending on the size of the firm and the extent of integration into
overall resources management systems.
Well-documented source of supplies and reliable information on properties may
provide a marketing advantage on external markets which require high reliability and

EN

231

Discussed in detail in [Sub-Title 2.4].

232

Study “The REACH contribution to the development, commercialisation and uptake of products ofemerging technologies”, Gaia, commissioned by the European Commission, 2012.

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stability with regard to requested properties. There are already firms declaring
business gains by using their compliance with REACH in order to market a productoutside the EU. One survey respondent from the Netherlands explained that REACH
had made the firm re-position its business in the area of environment and safety andadded: “Now we can show that we want to be a forerunner.”
However, the survey responses indicate a considerable level of scepticism towards thepotential of REACH to lead to improved customer confidence, with almost 80% of
respondents disagreeing with the idea that REACH has led to increased customer
confidence in chemicals in the EU.
With regards to the negative contribution of REACH, restrictions on uses or the costs
associated with registration and authorisation requirements may result in replacingEU-based production or chemical processes by imported articles (either parts or final
products) which are outside of scope from many provisions of REACH. Feedback
received to the survey revealed already individual cases of such relocation233.
REACH treats imported and domestic products in an equal manner, in line with the
WTO rules. In all respects, EU legislation ensures that when suppliers of chemical
substances are competing on the EU market, they are treated in an equal manner.
However, this does not necessarily create an equal basis for competition outside theEU. Despite export being exempted from many provisions of REACH (such as
restrictions, when related to placing on the market) very few companies are
exclusively trading outside the EU and REACH costs are affecting extra-EU export
activities in the same way as any intra-EU sales.
Most firms and associations suggested that it is still too early to identify long-term
impacts of REACH on their competitive position. In the short term, the financial
situation of most firms was reported to be negatively affected. The severity of this
impact depends on the type of product traded. For firms in highly competitive markets– as is the case for basic chemicals and metals that are treated as commodities –already low profit margins appear to have been further squeezed, as there is limited
capacity to transfer these costs to customers through price increases. In other markets– such as certain segments of the specialty chemicals – firms appeared more confidentof their capacity to increase prices and maintain profit margins without seriously
affecting their overall competitive position.

233

EN

Study “Functioning of the European chemical market after the introduction of REACH”, CSES,
commissioned by the European Commission, March 2012.

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2.4.

Single Market, Competitiveness and Innovation

Innovation
REACH fulfilled its objectives with regard to innovation. However, thepersisting innovation gap compared to US and Japan and increasing pressure
from emerging economies indicate a need for more ambitious objectives in thisarea.

Innovation has been placed at the heart of the Europe 2020 strategy for growth andjobs. It has been noted that in order to address the EU's challenges (like an ageing
population) with strong competitive pressures from rising economies, the EU's future
economic growth and jobs will have to come from innovation in products, services
and business models.
Innovation is a specific function of entrepreneurship, in either existing businesses, or
new ventures. It is a process of creating new wealth-producing resources or improving
existing resources which enhance potential for creating wealth234. On a micro level,
innovation is focused on a change in an economic or social potential of an enterprise,
while on a macro level, this translates into jobs and prosperity. In addition,
innovation, with the support of adequate regulation, can also result in reducing
impacts on the environment, enhancing resilience to environmental pressures by, e.g.,a more efficient and responsible use of natural resources235.
In recent studies it has been demonstrated that Member States with a strong
innovation baseline have coped with the crisis much better than others236. It has also
been demonstrated that innovative companies consistently perform better ingenerating new jobs across all size classes, and are much better in retaining
employment during economic downturns237. In addition, an often overlooked fact isthat young companies generate many more new jobs than established companies. In
the period 2002 to 2010 SMEs generated 85% of all new jobs added to the EU
economy, but established SMEs (older than 10 years), as a group, lost jobs during that
period). This implies that young companies not only added new jobs, but also
compensated for the loss of jobs which happened in the group of establishedcompanies. This indicates that innovation, which is essential to all new businesses, isthe backbone for social prosperity.
Innovating in chemicals
The chemical industry experienced an innovation boom in the middle of the lastcentury on a scale similar to the current one in the IT sector. From 1930 to the early

234

235

236

237

EN

Drucker P. F., The Discipline of Innovation, Harward Business Review, Issue May-June 1985.
Communication from the Commission […] Innovaton for a sustainable Future – The Ecoinnovaton Action Plan (Eco-AP), European Commission, 15.12.2011, {COM(2011) 899 final}, p.
2.
Vroonho P. et al., Do SMEs create more and better jobs?, EIM Business & Policy Research, study
funded by EU Competitiveness and Innovation Framework Programme.
Ibid.

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1980s, there were 63 major (or disruptive) innovations in chemical products238. In
subsequent decades, the pace of innovations gradually declined. Bringing new
products to the market became increasingly difficult in terms of time and resource
requirements. In addition, as the industry was increasingly regulated, it shifted its
focus towards innovating with traditional substances rather then developing disruptive
new ones.
More recently however, there are signs that disruptive innovations may return to thechemical industry, for example, due to a necessity attributed to increased scarcity ofnatural resources and thanks to regulatory changes introduced by REACH.
Efforts to avoid, where possible, use of chemicals that reduce future productivity of
key resources such as soil and water, and make waste materials more costly to recycle
and reuse may help to reduce pressures from increasingly scarce natural resources.
REACH helps to identify opportunities for switching to safer chemicals or
technologies whenever economically feasible. These alternatives will improve thequality of waste streams and thereby enhance recycling and reuse of the raw materials
contained in these streams. These opportunities will have to come from innovation
into new manufacturing processes or chemicals.
The Commission services believe that the EU chemical industry is well-positioned to
face these challenges as it has been strong in innovating and was doing better thanother EU sectors in many aspects. Indeed, an important benchmark comes from a
Patent Asset Index calculated by PatentSight239 which measures the combinedcompetitive impact of all patents in company portfolios and therefore an overall
technology strength. In this ranking, within the top-ten chemical companies five are
EU-based.
Figure 6. Patent Asset Index for leading chemical companies
BASF (EU)
Bayer (EU)
DuPont (US)Dow (US)
Sumitomo (JP)Mitsubishi (JP)DSM (EU)
Solvay (EU)Syngenta (CH)AkzoNobel (EU)
0

15000

30000

45000

Source: PatentSight 2011, [http:// http://www.patentsight.com]

EN

238

Bennett, M. J.; Kline, C. H., “Chemical: An Industry Sheds Its Smokestack Image”, Technology
Review 1987, July Issue, 36-45

239

Ernst, H., Omland, N., “The Patent Asset Index - A New Approach to Benchmark Patent
Portfolios”, (forthcoming)

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This strong position of EU companies indicates that the climate for innovation in the
EU has been favourable.
Innovating in REACH
As has been shown above, innovation in chemicals, in many ways, is different frominnovation in other sectors. Its specificity requires particular attention by public
policies. REACH, in that respect, plays an important role as it can affect (in positive
and negative ways) innovations at all stages of the innovative process. The
Commission has analysed the effectiveness of REACH in achieving innovation
objective at the following three stages of the innovation process:– invention (idea generation and evaluation);– implementation (development/prototype, pilot application, testing); and– marketing (production and market launch, market uptake).
It is questioned by some that business activities driven by REACH mechanisms suchas registration, the candidate list, restriction and authorisation can be considered as
drivers of future growth – an attribute of innovation as pursued by the Europe 2020
strategy240. In support of that view, it is argued that innovation must respond tomarket demands, while restriction and authorisation processes are, in effect, a result oflack of adequate market reactions. However, forced innovations may bring economic
benefit indirectly via improved quality of waste streams, productivity of natural
resources or by minimising external costs assumed by the society.
In addition, it has been brought to the attention of the Commission that 40% of
chemical companies observed a shift of R&D or other innovative practices into health,safety and environmental protection areas that would not otherwise have taken place.
Even more, a fundamental reappraisal of the research orientation had occurred within
5% of surveyed companies241.
Invention
REACH contains a number of mechanisms which impact on the willingness anddetermination to innovate. These are mechanisms which (i) mandate or induce
substitution (like the candidate list), (ii) increase the costs and administrative burden
for companies, (iii) generate new data and help identify customer needs.
Firstly, with regard to the substitution mechanisms, the impact of REACH on theinvention stage relates to the uncertainty around the candidate list. In the most
240

241

EN

Communication From The Commission - Europe 2020 - A Strategy For Smart, Sustainable And
Inclusive Growth, European Commission, 3.3.2010, {COM(2010) 2020}, p. 9: "Smart growthmeans strengthening knowledge and innovation as drivers of our future growth.”
Survey commissioned by the European Commission and conducted by CSES Ltd. in September
2011 on 500 chemical companies from EU (including manufacturers, downstream users and otheractors in the chemical supply chain) – further in the document referred to as an 'Innovation
Survey'.

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Single Market, Competitiveness and Innovationcommon response from the industry it is pointed out that the research on substances tosubstitute identified SVHCs in the candidate list is hindered by uncertainty regarding
the status of potential substitutes which may be included into the candidate list
themselves later on. It is argued that a greater predictability would certainly help.
Secondly, concerning costs of complying with obligations under REACH, theCommission’s original Impact Assessment had identified a concern that therequirements of the REACH regulation could divert resources from other research
activities. Unfortunately, the Innovation survey242 revealed that this indeed happened
as confirmed by more than 60% of respondents. However, nearly half of them also
stated that there was an overall increase in expenditure on R&D to compensate for thecompliance-related activities.
Finally, in the domain of availability of data, REACH introduced industrial
information transfer mechanisms aimed at capturing and disseminating data acrossindustries and throughout the supply chain to support and stimulate the developmentof safe chemicals and practices. This aspect is of particular interest for this stage ofinnovative process and will be looked in more detail below.
The main mechanisms for data capture and dissemination are SIEFs and consortia,
SDS and eSDS, and CSR and the ECHA dissemination portal.
About a quarter of respondents in the Innovation Survey (including adisproportionately large share of SMEs) indicated that they had found the SDS ofvalue in this regard. Registration dossiers with technical dossiers and CSRs were
found useful by one out of six, and SIEFs by one out of ten. This suggests that,
although the overwhelming majority did not find any use in innovative processes forthe new information, a noticeable share of companies did already benefit from thesesources – in particular the SDS which was the most useful tool in this respect. It
should also be noted that the first registration period dealt with large volume
substances which have been in use for a long period of time and whose properties
tended to be well known. More new data are therefore expected to be revealed with
the next registration deadlines when substances which are less well known are to beregistered.
An explanation why not more companies benefited from these additional information
sources may be found in the results of the survey on competitiveness where theexperience from communication along the supply chain was reported as negative by
44% of firms. The main problem, in this respect, appeared to be the absence of astandardised format for eSDS and their size of often more than 100 pages.
With regard to the quality of the information over 70% of participants in the
Innovation survey considered that there had been an increase in access and scrutiny of
the information, and nearly 20% indicated it increased a lot. In addition, nearly aquarter of respondents stated that they had been able to benefit from that increased
openness and scrutiny.

242

EN

Ibid.

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An important stimulus for idea generation also came from the better awareness of theapplication and uses of the substances down the supply chain due to communication
requirements. With the complex structure of the supply chains in the chemical sector,
manufacturers of substances are often separated by a large number of intermediaries
from the final recipient or user of the substance. Specific knowledge on the particularapplicability of specific substances may therefore not have reached manufacturers orimporters and important market opportunities may therefore have remained
uncovered. With the incentive to communicate all uses up the supply chain, themanufacturers got a much better overview of the range of uses for the substances intheir offer, and may react with optimised and improved offer. The Innovation Survey
found important evidence that this is indeed already taking place. Companies
indicated various ways in which they have innovated as a result of these processes: abetter dialogue with major customers and learning new information about substancesfrom the (e)SDS. As a result, new applications can be realised in a better and saferway (for the customers).
Implementation
The implementation stage of the innovation process comes after an invention passes
its initial business evaluation. It involves development of prototypes, testing andpiloting. REACH introduced some changes aimed at supporting this phase of theinnovation process, it: (i) equalised testing requirements for new substances withthose already existing, (ii) established various exemptions (volume, product andprocess oriented research and development, polymers and intermediates) in support ofresearch and development, (iii) allowed read-across of test results that would reduce
costs of testing in general and the need to undertake animal testing in particular.
With regard to equal treatment, REACH levered conditions for both new andexisting (phase-in) substances to undergo testing and safety assessment within theregistration process. This requirement equalised the costs of developing new products
based on new substances with costs of continued use of existing substances. The
Innovation Survey confirmed that this approach is effective: nearly half of the
respondents stated that this was a problem and a third agreed that REACH has
effectively addressed it. However, interviews with the industry indicated that somebarriers for research activity on new substances under REACH still exist. For
example, for non-phase-in substances in the low tonnage band (between 1-10 tonnes
per year) one has to provide the standard test data of Annex VII while there is no suchrequirement for phase-in substances (except if they meet one of the criteria fromAnnex III). But despite these differences, ECHA has received as many registrations243
for new substances as was estimated in the original Impact Assessment, thereby fully
meeting the Commission's projections.
With regard to exemptions under REACH, the most important is the exemption for
substances used in pilot plant or production trials to test the production process or test
the fields of application of the substance (PPORD). It extends to registration,
243

EN

By end of 2011, ECHA received 1670 registrations for non-phase-in substances, which gives anaverage of 477 substances per year (registration obligation under REACH was effective as of 1
June 2008)

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authorisation and restrictions. Until January 2012, there have been around 800
notifications for use of that exception from registration submitted to ECHA. This israther a small number compared to the size of the chemical industry, which may be
explained by the fact that currently only high volume substances have to be registered.
The Innovation Survey also found that 15% of interviewed companies haverecognised this as an opportunity to intensify their R&D activity and applied for
PPORD (of which 75% were large enterprises). At the same time, an important shareof companies reported that the duration was sufficiently long (5 years) to conduct
necessary R&D. Another exemption, from authorisation and restrictions, is available
for substances used in scientific experimentation, analysis or chemical research in a
volume of less than one tonne per year. Feedback from the survey suggests that thevolume exemption may often be too low for the testing required.
As regards exemptions for polymers it should be pointed out that the exemption was
intended to maintain innovation within this domain, and consequently, the majority ofsurveyed companies were of the view that this did not contribute to increased
innovation. A similar response was provided to the exemption which relates toisolated intermediates (on-site or transported)
With regard to read-across and animal testing nearly 50% of survey respondents
indicated that provisions within REACH for the use of read-across as regards research
testing results led to a reduction in the need (and costs) for testing. However, thesurvey responses also took a view that ECHA has used a very strict (precautionary)interpretation of their testing proposals and results, lowering the impact of thismeasure on innovation.
MarketingThis end stage of the innovation process involves the establishment of production,
launch of products and market uptake. The following aspects were identified as
applicable to this stage: intellectual property protection, patenting, registration costs
and market uptake.
The main areas of concern identified with regard the protection of intellectual
property were: (a) information requirements to downstream users through the (e)SDS(potentially leading to the disclosure of critical know-how related to the formulation
technology used); (b) loss of key intellectual property where procedures cannot be (orwere not) patented, and (c) concerns in relation to the required data and information
sharing among SIEF members. In relation to patenting, there were questions as towhether the pre-publication requirements under REACH may result in difficulties inprotecting new developments under patent law.
The Innovation Survey found that some 75% of respondents did not think that there
were conflicts as regards protecting intellectual property and making information
available at registration and throughout the supply chain. Among those that did,conflicts tended to arise mostly in the context of SIEFs, and preparation of the SDS
and CSR. Some 18% of surveyed companies asserted that REACH provided forsufficient protection of intellectual property to promote innovation, but 40% were of
the opposite view (with another 40% having no opinion). A somewhat more positive
assessment was given to the provisions intended to protect confidential business

EN

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information – with nearly 20% of the companies stating that they were sufficient tosupport innovation, versus 35% that had an opposite view.
With regard to registration costs, the feedback from industry points out that new
innovation projects are more highly scrutinised in terms of costs, risks and returns
before it is decided to go ahead with launch and marketing – also further up the
pipeline – than it was before the implementation of REACH. This may be linked to
the fact that over 40% of firms considered time to market as being increased, while
over 10% expected a reduction of this time to market. It seems that some of the larger
firms that would have submitted multiple notifications across several Member Statesprior to REACH have been able to benefit from not having to deal with thisrequirement at Member State level.
With regard to market update, an expected gain has been reported by some 25% of
respondents who indicated that compliance has contributed to a better acceptance of
their new products and technologies by the market.

2.5.

Perspective of SMEs
REACH has increased concentration on the market by various mechanisms.
Greater specialisation among chemical suppliers and new compatible
business models resulted in a need for restructuring the supply chain. This
opens a number of opportunities, but due to financial and organisational
constraints, SMEs are less likely to succeed, if not properly supported.

The population of SMEs is a highly diverse group of firms. They range from microfirms to mini-multinationals, and could fill one or several of the REACH roles. SMEs
also have a different role in the economic structure depending on the economies
involved. And while only 14% of dossiers in the first registration deadline were
submitted by SMES244, many more are expected to participate in the next registration
deadline, or are already now concerned by other obligations of REACH.
REACH has taken into account the specificity of SMEs in a number of ways, like
reductions in registration fees, testing requirements increasing progressively withtonnage band, different registration deadlines depending on the tonnage, etc. But
notwithstanding these measures, the feedback received from SMEs clearly shows thatthey still tend to be disadvantaged by REACH compared to large firms. The
Commission has looked at the effects of REACH on SMES with regards to access tomarkets, innovation and protection of intellectual property.
As regards access to supply markets, the key driver of accessibility is the effect ofregistration costs, whether as a manufacturer, a formulator or a distributor. The
Commission has been informed of SME having problems in financing letters of

244

EN

Dossier Submission Report On 1 December 2010, ECHA, available at www.echa.europa.eu

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access to participate in joint submission, or having to review business relationships
with long-standing suppliers pending appointment of an only representative.
When all registration costs are taken into account, a pattern may be observed
whereby, despite significant fee reductions, micro- and small firms are paying
disproportionately more in relative terms to their sales due to the fixed costs incurred
by REACH compliance (e.g. SDS and eSDS, translations, IT systems, legal services,
letters of access).
In addition, there may be cases where SMEs, would be more impacted due to theirlower abilities to pass on the costs via the increases of the price where dominantmarket players are larger companies. Furthermore, SMEs may not be so wellequipped for the expansion to other customer areas, especially if e.g. safetyassessment requirements between respective regulatory areas differ considerably fromeach other.
As for the situation of “not yet existing SMEs”, it should be recognised that thecomplexity of REACH, manifested by the existence of thousands of pages of various
guidance documents, impacts on entrepreneurship within the chemical sector.
Altogether, these factors may discourage SMEs from starting activities implying
REACH obligations.
However, with regard to innovation, small firms have indicated that they havebenefited proportionately more than larger firms in terms of conception of products
resulting from increased openness, particularly from the SDS. On the other hand,
SMEs reported more often than larger companies that they had experienced a transfer
of resources from market-driven innovative projects to compliance-related work.
They more often saw this shift as permanent and more often reported concerns withregard to protection of confidential business information or intellectual property
protection under REACH. As a consequence, SMEs have so far made less use of theresearch exemptions under REACH than larger firms.
2.6.

Summary and conclusions

REACH maintains its relevance in relation to both objectives of competitiveness andthe contribution to the harmonisation of the single market. Both objectives can beserved by the effective and efficient implementation of REACH on the basis of thepromotion of innovation in chemicals, the minimisation of the implementation costs,
and the pre-emption of the creation of national regulations as regards chemicals that
could lead to a fragmentation of the EU market.
REACH as an EU Regulation is considered by the industry as positive in avoiding a
possible fragmentation from the potential introduction of separate national
legislations. Despite the feedback received pointing to some variation in the way
Member States monitor or enforce REACH, the existing coordination structures

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Single Market, Competitiveness and Innovation(CARACAL, the Forum, enforcement projects and RIPE245) are seen as having a
positive impact.
The compliance requirements of REACH introduced sizeable costs for almost all
firms in the chemicals market. The key drivers of compliance costs are, at this point,
the costs of registration – including data collection and ECHA fees – as well as
communication and exchange of information along the supply chain. The available
data suggest that the costs for the first registration period incurred by suppliers ofchemicals – manufacturers and importers of chemicals – were around € 2.1 billion.
This figure includes amounts paid for access to existing data which is not considered
as a net cost for the industry (and was not accounted for in the Impact Assessment).
However, with regard to the use of (Q)SAR as a low cost data collection method, theinitial estimations were much more optimistic than the actual use by the industry; thiscontributed in part to higher overall cost than anticipated.
So far, it can be concluded that the industry seems able to absorb the additional costs
with, in general, no significant adverse effects on its overall competitiveness and witha general acceptance of the longer-term objectives. There is no evidence available atthis stage indicating sizeable shifts in terms of both imports and exports of chemicals
as a result of REACH.
There are significant deviations in terms of expected impacts and certain firms or
sectors appear more vulnerable than others in the process. The data analysis provided
by the commissioned surveys indicates that small firms, firms in sectors with lessintegrated supply chains, or firms that rely on the use of chemicals on the candidate
list often face greater challenges as a result of REACH. SMEs appear to lose part oftheir market share either as a result of the costs, or as a result of withdrawals of
substances from the market or reduction of production levels. This is because, in
relative terms, the costs of compliance with REACH tend to be partially independent
from the volume (e.g. supply chain communication, or letters of access costs). In
addition, REACH requirements and administrative procedures make their margins
lower in comparison to non-EU competitors with a potential longer term impact intheir capacity to compete inside and outside the EU.
Fortunately, the analysis also indicates that there is significant scope for reducing thecosts of compliance without a detrimental effect on other objectives of REACH. In
addition, further addressing differences in monitoring and enforcement of REACH
could increase the harmonisation effect of the single market.
With regard to impact on other industries, the implementation of REACH does have acertain impact on the availability of chemical substances used by DUs. The
withdrawal of substances is driven primarily by the registration costs, but also, for asmaller number of firms, by the inclusion of substances in the candidate list. There isno evidence at this stage that substance withdrawal has had an impact on final
customers in terms of the variety of final products available or their prices. On thebasis of the above it can be concluded that REACH caused some reduction in the

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ECHA’s REACH Information Portal for Enforcement, see [Title 12].

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Part II.
Achieving REACH objectives

Single Market, Competitiveness and Innovation

number of suppliers of chemicals and, in consequence, is leading to a greater
concentration of the market.
Recommendations:II.1. ECHA and industry associations should reinforce their efforts to reduce the overall costs incurredby the industry in complying with REACH. This should be done by:a. simplifying and optimising guidance for businesses (taking into account costs of adaptationand familiarisation),b. facilitating transmission of best practices between companies,
c. providing information on the age of data in inquiry process,d. further development of QSAR, read across and other alternative hazard assessment
methods, to enable their regulatory acceptability.
II.2. ECHA and industry associations should reinforce their efforts to ensure protection of IP rights
and confidential business information, in particular by simplifying and optimising guidance forbusinesses, in particular for SMEs, about existing possibilities under REACH to safeguard IP
rights and confidential business information
II.3. Provide additional support to SMEs. In particular the following means should be explored:a. by ECHA - more specific guidance on transparency, non-discrimination and fair cost
sharing.
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b. within the scope of the review of the Fee Regulation , consider further rebalancing the
distribution of fees across various company size classes.
c. by national helpdesks and/or ECHA – guidance on effective integration of regulatory
requirements into product development and commercialisation.
II.4. The Enterprise Europe Network will be used to increase awareness of REACH along the supply
chain and to improve the communication within the supply chain.

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Commission Regulation (EC) No 340/2008 of 16 April 2008 on the fees and charges payable to theEuropean Chemicals Agency pursuant to Regulation (EC) No 1907/2006 of the European
Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction ofChemicals (REACH), OJ L 107, 17.4.2008, p.6.

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Part III.
CLP ENFORCEMENT ACTIVITIESIntroduction
The CLP Regulation247 sets the rules for classification, labelling, and packaging ofchemical substances and mixtures at EU level. Its main objectives are to determine
whether a substance or mixture displays properties that lead to a classification as
hazardous and to harmonise the standard symbols, phrases and packaging conditions
that should be used to inform users. The Regulation aligns previous EU legislation onclassification, labelling and packaging of chemicals248 to the United Nations Globally
Harmonised System of Classification and Labelling of Chemicals (GHS). It maintains
the previously existing level of protection of human health and environment andintends to facilitate EU internal as well as international trade in chemicals.
CLP entered into force on 20 January 2009. The underlying principle of thislegislation, which applies to substances from 1 December 2010 and to mixtures from
1 June 2015, is that industry is responsible for classifying and labelling substancesand mixtures. For substances with particularly severe hazards, national authorities orindustry propose harmonised classifications on which the Risk Assessment
Committee (RAC) of the European Chemicals Agency (ECHA) provides opinions.
Based on those opinions, the Commission, if found appropriate, includes the
harmonised classifications into Annex VI to CLP, through which they become
mandatory. When a substance or mixture is classified for one or several hazards, therelevant information is communicated to other actors in the supply chain, including toconsumers, via particular elements on the labels of products placed on the market and,
where relevant, via safety data sheets.
Manufacturers and importers are also obliged to notify the classification and labellingof the substances placed on the EU market after December 2010 to the classificationand labelling inventory (the C&L Inventory) managed by ECHA. It contains entries
for more than 115 000 substances and a public version is available on ECHA’s
website249.

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Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December
2008 on classification, labelling and packaging of substances and mixtures, amending andrepealing Directive 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006(OJ L 353, 31.12.2008, p.1).

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Directive 67/548/EEC of 27 June 1967on the approximation o the laws, regulations andadministrative provisions relating to the classification, packaging and labelling of dangerous
substances (OJ 196, 16.8.1967, p. 1) and Directive 1999/45/EC of the European Parliament and of
the Council of 31 May 1999 concerning the approximation o the laws, regulations andadministrative provisions relating to the classification, packaging and labelling of dangerous
preparations (OJ L 200, 30.7.1999, p. 1).

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http://echa.europa.eu/web/guest/information-on-chemicals/cl-inventory-database

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CLP Enforcement Activities

Enforcement and reporting
Enforcement
In general, enforcement of EU legislation lies within the responsibility of Member
States. In order to ensure an effective implementation of CLP, Member States are
obliged, among others, to:– take all necessary measures, including maintaining a system of official controls toensure that CLP is applied;– introduce penalties for non-compliance with the Regulation and notify them to theCommission;– regularly report on enforcement.
This chapter is mainly focused on the analysis of the Member States' obligation on
regular reporting. Other initiatives that could play a role in CLP enforcement are
mentioned solely to provide an overall picture.
The enforcement of CLP is closely related to the enforcement of REACH. The
classification and labelling of substances is part of REACH registration dossiers andSafety Data Sheets required under the REACH Regulation also have to contain thecorrect classification of chemical substances or mixtures. Furthermore, the activities
of ECHA’s Forum for exchange of information on enforcement also include CLP.
Further information on the Forum's work, information exchange and the Commission
services' recommendations concerning enforcement of CLP and REACH are therefore
to be found in [Title11 of Part I] of this paper.
In addition, the consequences of the classification of chemical substances under CLP
go well beyond the Regulation itself. Classification is often used as a reference totrigger obligations or restrictions under many others pieces of legislation such as thePressure Equipment Directive250, Toys Safety Directive251, Seveso Directive252,
Regulation on the EU Ecolabel253 and Regulation on Cosmetic Products254.
Member States reporting
Article 46(2) of CLP requires Member States to submit a report to ECHA every five
years by 1 July, on the results of official controls and other enforcement measurestaken. The first report had to be submitted to ECHA no later than 20 January 2012.

EN

250

OJ L 181, 09.07.1997, p. 1.

251

OJ L 170, 30.06.2009, p. 1.

252

OJ L 10, 14.01.1997, p.13.

253

OJ L 27, 30.1.2010, p. 1 .

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OJ L 342, 22.12.2009, p. 59.

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CLP Enforcement Activities

ECHA shall in turn make the reports available to the Commission, which shall takethem into account when preparing its general report under Article 117 of REACH.
With this aim, the Forum mandated a working group to develop a template and adocument with common issues on enforcement that should be reported under Article
46(2) of CLP. The reporting template has been the main tool used by Member States
to submit consistent and comparable data. ECHA has reviewed the information
received from Member States and evaluated its usefulness. The results of thoseobservations has been summarised in a report sent to the Commission in March 2012
together with the national reports.
The reports cover national enforcement strategies, describe the co-ordination and cooperation among national authorities and document enforcement activities during thereporting period, which covers the time between the entry into force of CLP (20January 2009) and June 2011.
Enforcement activities encompass a range of actions an authority may undertake inorder to assess, secure or promote duty holders’ compliance with CLP. Activities may
be routine or non-routine and include inspections, investigations, monitoring as well
as formal enforcement (i.e. issuing warnings, bringing legal proceedings by criminalor civil means).
It should be noted that as a consequence of this having been the first reporting and thetemplate having been made available only rather late in the process, it was difficult for
Member States to gather data during the enforcement activities that could then be
easily adapted to the level of detail required in the reporting template. It was also
complex to differentiate between controls of products classified and labelledaccording to the Directive on the classification and labelling of dangerous substances(which was still possible until 30 November 2010, meaning for nearly 22 out of 28
months of the reporting period) and the Directive on the classification and labelling of
dangerous preparations (which is still applicable until 2015) or according to CLP.
Furthermore, CLP-related violations cannot always be distinguished fromenforcement of other specific legislation, such as for toys, plant protection products,
detergents, cosmetics, REACH, etc. Overall 26 Member States submitted reports andmore than a half thereof contained quantified data for the reporting period.
The results of official controls and other measures submitted by the Member States
showed that in the short period that was covered in the first reporting exercise, it was
not possible to carry out any type of statistical analysis on the results. However, fromthe data available some trends may be concluded:– All Member States appointed authority/ies for the enforcement of CLP. The
administrative structures of enforcement authorities differ from one Member State
to another and, often, more than one authority plays a role in the enforcement of
CLP. The level of enforcement differs between Member States but most of theMember States have elaborated specific enforcement strategy/ies that are in linewith the strategy developed by the Forum.
– In most of the Member States there are mechanisms in place to ensure cooperation,
coordination and exchange of information on enforcement of CLP. This is

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CLP Enforcement Activities

achieved via a variety of instruments such as the performance of joint inspections,use of electronic databases (e.g. ICSMS255, REACH-IT, HelpEx256), participationin coordinated Forum projects, cooperation with national Helpdesks, dedicatedworkshops, training and meetings.
– The information provided suggests that the total number of official controls on
products carried out by enforcement authorities in the EU, as a whole, has
increased during the three years covered by the reporting period. From 38.778 in2009 to 46.815 in 2011, with a total of 127.436 official controls or otherenforcement measures during the period 2009-2011. The same increasing trend has
been observed in many Member States.
– Accordingly, also the number of duty holders subject to enforcement has increasedin that period. Downstream users have the largest share in the number of duty
holders subject to enforcement, followed by distributors, importers and finally
manufacturers. The size of duty holders subject to enforcement activities differs
between Member States. In general, mostly small and medium size duty holders
were inspected. Even micro duty holders were the largest targeted group in several
Member States– The official controls addressed the duties concerning the following categories ofissues: hazard classification, hazard communication in the form of labelling,
packaging, harmonisation of classification and labelling of substances, notification
to the C&L Inventory, obligations to maintain information and requests for
information, and other CLP obligations. The main areas where cases of noncompliance were found are the hazard classification and hazard communication in
the form of labelling and packaging.
– In terms of absolute figures, Bulgaria, Estonia, Finland, Greece, Hungary and
Poland were the most active Member States of those who submitted reports withquantified data. The data from Finland have the largest impact on the aggregateddata summarising official controls of products for the Member States for thereporting period. The same Member State also reported the highest number ofcases of non-compliance for all reference years followed by France for the last two
reference years.
– Generally the compliance rates amount to 70%. About 20% of the official controls
resulted in verbal or written advice. Less than 8% of the official controls led toformal enforcement measures such as enforcement notices or administrative
sanctions. Only less than 1% of controls led to legal proceedings. Out of those, fiveended in convictions by a Court.
These figures are the baseline for the future reporting and indicate that there is still
substantial room for improvement of compliance. More comparable data from

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255

Internet-supported information and communication system for the pan-European market
surveillance of technical products

256

Web-based discussion platform for national Helpdesks

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Part III.
CLP Enforcement Activities

Member States are needed in the future. This will be beneficial not only for Member
States but also for the Commission, in order to get a solid basis for further
development of a more harmonised approach of Member States towards enforcementof CLP.
It should also be noted that the number of official controls on notification to the C&L
Inventory, as required by Article 40 of CLP, has played a minor role when comparedto the total number of official controls (around 4% of total controls). However, it is to
be expected that the Inventory will play a bigger role in the next enforcement report tobe received from the Member States in 5 years. The Inventory provides easy access to
information on the hazardousness of a given substance, facilitating the task tocorrectly classify and label substances and mixtures. In case of divergent
classifications for the same substance, industry as well as enforcement authorities
have the possibility to further check whether the classification and labelling on agiven products is correct and companies having notified classification and labelling
for the same substances are obliged to undertake all efforts to come to agreed entries
or to identify the legitimate reasons for diverging classifications.
Conclusions and recommendations
CLP sets the rules for classification and labelling of chemical substances andmixtures. The processes for its implementation are relatively recent. In order to ensure
effective implementation in practice, Member States are obliged to establish thenecessary arrangements for enforcement. Especially a strong and harmonised
approach towards enforcement of CLP throughout the EU is vital for delivering its
objectives. Despite significant efforts of Member States also within the Forum a more
harmonised approach towards enforcement of CLP is still a challenge.
The reports submitted by Member States for the first reporting period (2009 - 2011)
showed large variations in the level of detail and the issues addressed. Differenceswere also apparent in results between the years and depending on the Member State.
Inconsistencies in the reporting by Member States further complicated thecomparative analysis of the data.
However, from the data received, it can be concluded that the total number ofinspections has increased over the last three years but that the compliance rate of the
duty holders with their obligations could be substantially improved. In theCommission services' view, this can be achieved through, among others, harmonised
and targeted enforcement projects focusing on the areas of detected non-compliance
as well as further development and implementation of the Forum enforcement
strategies regarding CLP. Such projects should always incorporate an element ofawareness raising particularly focussed on SMEs, which, in fact, are the vast majorityof duty holders under CLP.
Enforcement is a Member States led activity but having a clear picture about
enforcement of CLP on the basis of consistent and comparable data would be to theadvantage of all. The Commission, alongside with Member States, in the Enforcement
Forum, could have a role in developing enforcement indicators for reporting purposes[Title 11 of Part I]

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CLP Enforcement Activities

The enforcement of CLP is closely related to the enforcement of REACH. Member
States pursue their CLP inspections often jointly with REACH inspections. Therefore
the recommendations related to enforcement of REACH in this paper are also relevant
to CLP.
This applies especially to the Commission's recommendation addressed to Member
States to enhance their support to Forum members by providing full scientific,
technical and administrative assistance, as well as the Commission's recommendationencouraging the prioritisation of enforcement and inspections across the EU in orderto focus the limited resources of national enforcement authorities to achieve the mostbenefits as regards compliance.

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