Guidance on requirements for
substances in articles

May 2008
Guidance for the implementation of REACHLEGAL NOTICEThis document contains guidance on REACH explaining the REACH obligations and how to
fulfil them. However, users are reminded that the text of the REACH regulation is the only authentic legal reference and that the information in this document does not constitute legal advice. The European Chemicals Agency does not accept any liability with regard to the contentsof this document. © European© European Chemicals Agency, 2008
Reproduction is authorised provided the source is acknowledged.

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GUIDANCE FOR ARTICLESPREFACEThe main objectives of this guidance are to:!

Assist the REACH actors in deciding whether or not they are manufacturers or importersof substances (on their own or in preparations) or article suppliers!

Assist article suppliers (article producers, article importers and/or distributors/retailers ofarticles, as well as only representatives of non-EU companies exporting articles to the EU)
in deciding if they have to fulfil registration, notification and/or communication requirements related to substances in their articles

The meeting of the REACH Member State Competent Authorities (REACH-CA meeting) of 19-20
December 2007 could not reach consensus on some elements of this guidance on requirements for
substances in articles and the Commission decided to transfer the finalised text, being endorsed by
the majority of Member State Competent Authorities, to ECHA for publication. The positions weremaintained at the REACH-CA meeting of 27-28 March 2008. Hence ECHA sought the advice of its
Management Board in its meeting of 23-24 April 2008. At this occasion the majority of the members of the Management Board supported the publication of the guidance document in its current
state. However, dissenting views with regard to the application of the 0.1 % threshold were upheldby a significant number of Management Board Members and have been notified to ECHA in writing by 6 Member States (Austria, Belgium, Denmark, France, Germany and Sweden). In line withthe consultation procedure on guidance (MB/30/2007 final dd. 29/02/2008) a reference to the notified dissenting positions has been added to the relevant parts of the guidance document.
This guidance document is part of a series of guidance documents that are aimed to help all stakeholders with their preparation for fulfilling their obligations under the REACH regulation. These
documents cover detailed guidance for a range of essential REACH processes as well as for somespecific scientific and/or technical methods that industry or authorities need to make use of under
REACH.
The guidance documents were drafted and discussed within the REACH Implementation Projects(RIPs) led by the European Commission services, involving all stakeholders: Member States, industry and non-governmental organisations. These guidance documents can be obtained via the websiteof the European Chemicals Agency (http://echa.europa.eu/reach_en.asp). Further guidance documents will be published on this website when they are finalised or updated.
This document relates to the REACH Regulation (EC) No 1907/2006 of the European Parliamentand of the Council of 18 December 2006 1.

1

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 of Chemicals (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 396, 30.12.2006); amended by Council Regulation (EC) No 1354/2007
of 15 November 2007 adapting Regulation (EC) No 1907/2006 of the European Parliament and of the Council on theRegistration, Evaluation, Authorisation and Restriction of Chemicals (REACH), by reason of the accession of Bulgaria
and Romania (OJ L 304, 22.11.2007, p. 1).
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GUIDANCE FOR ARTICLESCONTENT
1 GENERAL INTRODUCTION ............................................................................................................................... 11
1.1 Who is this guidance for? ............................................................................................................................... 11
1.2 Why this guidance is needed and how to use it .............................................................................................. 12
2 REQUIREMENTS FOR SUBSTANCES IN ARTICLES UNDER REACH ........................................................ 14
2.1 Registration according to Article 7(1) (and 7(5)) ........................................................................................... 15
2.2 Notification according to Article 7(2) ............................................................................................................ 16
2.3 Obligations according to Article 33 ................................................................................................................ 16
2.4 Restrictions ..................................................................................................................................................... 17
2.5 Timelines under REACH................................................................................................................................ 17
2.6 Other relevant legislation ................................................................................................................................ 19
2.7 Packaging and containers ............................................................................................................................... 20
2.8 Documentation ............................................................................................................................................... 20
3 DECIDING WHAT IS AN ARTICLE UNDER REACH ...................................................................................... 21
3.1 The function of an object ................................................................................................................................ 21
3.2 The shape, surface and design of an object .................................................................................................... 22
3.3 Workflow for deciding if an object is an article or not ................................................................................... 22
3.3.1 Borderline in the sequence of processing natural or synthetic materials to final articles .................... 23
3.3.2 Borderline between substances/preparations in special containers / on special carrier materials andsubstances/preparations being (integral) parts of an article ................................................................. 25
3.3.3 Requirements for objects which are substances/preparations in containers ........................................ 29
4 INFORMATION VIA THE SUPPLY CHAIN....................................................................................................... 30
4.1 Obtaining standardised information from suppliers ....................................................................................... 30
4.2 Requesting non-standardised information up the supply chain ...................................................................... 31
5 CHEMICAL ANALYIS OF SUBSTANCES IN ARTICLES ................................................................................ 35
5.1 Chemical analysis in the context of substance registrations ........................................................................... 36
5.2 Chemical analysis of substances on the candidate list for authorisation......................................................... 37
6 REGISTRATION AND OR NOTIFICATION REQUIREMENTS ....................................................................... 39
6.1 Workflow on identification of potential requirements related to articles ....................................................... 40
6.2 Substances intended to be released from the article ....................................................................................... 41

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GUIDANCE FOR ARTICLES
6.3 Substances on the candidate list for authorisation .......................................................................................... 41
6.4 Time of checking compliance ......................................................................................................................... 41
7 SUBSTANCES INTENDED TO BE RELEASED FROM ARTICLES ................................................................ 42
7.1 Workflow on checking if registration is required ........................................................................................... 42
7.2 Screening at article level - checking the total tonnage of articles ................................................................... 43
7.3 Screening at preparation level ........................................................................................................................ 44
7.3.1 Volume of substances/preparations in articles is known ..................................................................... 44
7.3.2 Volume of articles is known ................................................................................................................ 45
7.4 Identification of substances intended to be released ....................................................................................... 46
7.5 Checking whether the substances are exempted from registration ................................................................. 46
7.6 Checking for existing registration for that use ................................................................................................ 47
7.7 Total amount of each substance intended to be released ................................................................................ 47
7.7.1 Calculation of the total amount of a substance intended to be released contained in articles ............. 48
7.8 Registration of substances intended to be released from articles .................................................................... 49
8 CHECKING IF ARTICLE 33 AND ARTICLE 7(2) APPLY ................................................................................ 51
8.1 Obtaining information about substances of very high concern on the candidate list ...................................... 51
8.2 Determining whether the article contains substances of very high concern ................................................... 51
8.3 Workflow for checking whether forwarding information and notification are required................................. 53
8.4 Determination of the concentration of SVHC – focus on articles with different components........................ 54
8.5 Check for an intended release of the SVHC ................................................................................................... 55
8.6 Check for an existing registration for that specific use................................................................................... 55
8.7 Determine the total amount of substances on the candidate list in all articles ................................................ 56
8.8 Can exposure be excluded during normal or reasonably foreseeable conditions of use ................................. 56
8.8.1 Use and function of the substance and the article................................................................................ 57
8.8.2 Potential for release ............................................................................................................................. 57
8.8.3 Exposure to humans and the environment ........................................................................................... 58
8.9 Forwarding information according to Article 33 ............................................................................................ 58
8.10 Notification of a substance in articles ............................................................................................................. 60
9 CHECKING WHETHER A SUBSTANCE IN AN ARTICLE HAS BEEN REGISTERED FOR THAT USE.... 62
9.1 Information in the supply chain ...................................................................................................................... 63
9.2 Information requests to the Agency ................................................................................................................ 63

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GUIDANCE FOR ARTICLESTABLES
Table 1 Timelines for article suppliers ......................................................................................................................... 19
Table 2 Availability of information in the supply chain ............................................................................................... 32
Table 3 Requests for information in the supply chain .................................................................................................. 48
Table 4 Information types for communicating on SVHC in article - Example ............................................................ 60

FIGURES
Figure 1 Article suppliers: producers, importers and distributors of articles ............................................................ 12
Figure 2 Decision taking on the article definition..................................................................................................... 23
Figure 3 Deciding on borderline between substances/preparations in special containers / carrier materials or as
integral part of articles .................................................................................................................................................. 26
Figure 4 Identification of requirements for substances in articles ............................................................................ 40
Figure 5 Workflow for checking if registration is required ...................................................................................... 43
Figure 6 Checking the requirement to notify and to forward information on SVHC ............................................... 54

EXAMPLES
Example 1
Example 2
Example 3
Example 4
Example 5
Example 6
Example 7
Example 8
Example 9
Example 10
Example 11
Example 12

Substances / preparations in a container - Toner Cartridge .................................................................... 28
Substances/preparations on a carrier material - wet wipes ..................................................................... 29
Substances/preparations as integral part of an article ............................................................................. 29
Identification of substances intended to be released - fragranced T-shirt ............................................... 37
Example - releases from a scented eraser ............................................................................................... 41
Preparation intended to be released - smelling eraser ............................................................................. 45
Substance intended to be released - smelling eraser ............................................................................... 46
Reduction of substance volume to be registered..................................................................................... 49
Registration of same substance in several articles .................................................................................. 49
Registration of substance intended to be released ................................................................................ 49
Calculation of a concentration .............................................................................................................. 55
Calculation of the total amount of a SVHC used in production or imported ........................................ 56

List of Appendices
Appendix 1: Definitions and Explanations
Appendix 2: Borderline cases of substances/preparations in special containers/on special carrier materials or as integral
parts of articles
Appendix 3: Examples on deciding the borderline in the sequence of processing natural or synthetic materials into final
articles, in particular deciding on 'semi-finished products'
Appendix 4: Illustrative cases for checking if requirements under Article 7 and article 33 may apply
Appendix 5: Information sources on substances in articles
Appendix 6: Information sources on restrictions and methods for determination of substances released from articles
Appendix 7: Legislation restricting the use of substances in articles

7GUIDANCE FOR ARTICLESABBREVIATIONS/y

Per yearCAS

Chemical Abstract Service

CMR

Carcinogenic, mutagenic and toxic for reproduction

Conc.

Concentration

DU

Downstream User

EIF

Entry Into ForceEINECS

European Inventory of Existing Commercial Chemical Substances

ELINCS

European List of Notified Chemical Substances

ELVs

End of Life Vehicles

ES

Exposure Scenario

eSDS

Extended Safety Data Sheet

ESIS

European chemical Substances Information System

EU

European Union

F

Formulator

GC-MS

Gas Chromatography – Mass Spectrometry

GHS

Globally Harmonised System for Classification & Labelling

ID-no

Identification number

ID number

Identification number

IUPAC

International Union of Pure and Applied Chemistry

M

Manufacturer

M/I

Manufacturer/Importer

PBT

Persistent, Bioaccumulative and Toxic

P/I

Producer/Importer

Prep.

Preparation

REACH

Registration, Evaluation, Authorisation and Restriction of Chemicals

RIP

REACH Implementation Project

RMM

Risk Management Measures

RoHS

Restriction of the Use of certain Hazardous Substances in Electrical and Elec-9

GUIDANCE FOR ARTICLES
tronic Equipment
SCCNFP

Scientific Committee on Cosmetic Products and Non-food products intended forConsumers

SDS

Safety Data Sheet

SIEF

Substance Information Exchange Forum

SMEs

Small and Medium-Sized Enterprises

Subst.

Substance

SVHC

Substances of Very High Concern

TGD

Technical Guidance Document

Vol

VolumevPvBvery Persistent and very Bioaccumulative

WEEE

Waste Electrical and Electronic Equipment

w/w

Weight per weight10

GUIDANCE FOR ARTICLES

1GENERAL INTRODUCTION

This guidance interacts with several other REACH guidance documents. As a general principle, thecurrent document will not repeat what is in other guidance documents, unless found absolutely necessary for the purpose of this guidance. Consequently, there are several references to other guidance documents and tools, which can be found (now or in the near future) on the web-site of theEuropean Chemicals Agency: http://ec.europa.eu/echa/.

1.1

Who is this guidance for?

This guidance document is addressed to producers, importers and suppliers of articles located in the
EU as well as only representatives of non-EU suppliers of articles.
The main objectives of this guidance are to:!

Assist the REACH actors in deciding whether or not they are manufacturers or importersof substances (on their own or in preparations) or producers/importers of articles

Assist article suppliers (article producers, article importers and/or distributors/retailers ofarticles, as well as only representatives of non-EU companies) in deciding if they have tofulfil registration, notification and/or communication requirements related to substances intheir articles
A company has the role of an article producer, if it produces articles within the EU, regardless of
how it is produced and where the article is placed on the market. An article importer is any company located inside the EU which imports articles from countries which are located outside the EU.
An article supplier is a company which produces, imports or distributes articles and/or places themon the EU market. Retailers are also article suppliers. Further explanation and the definitions ofthese roles are included in Appendix 1 of this guidance.
!

Non-EU producers of articles may appoint “Only Representatives” to fulfil all obligations of theimporters of their articles into the EU. In this case, Only Representatives shall fulfil all obligations
for substances in articles, including pre-registration and registration of substances with an intended
release (Article 7(1)), notification of Substances of Very High Concern on the so-called “candidatelist” 2 under Article 7(2), provision of information under Article 33 and ensuring compliance withany restrictions in Annex XVII. Details on the role and obligations of Only Representatives can befound in the Guidance on registration and Guidance on data sharing.
This guidance mainly describes how a company can check whether it has to fulfil any requirements
under Article 7 and Article 33 of REACH.
Please note that if article producers use substances and preparations (bought on the EU market) in
the production process of the article, they also have to fulfil downstream user requirements. Support
is provided in the Guidance for Downstream Users. If the article producer also is the importer ofsubstances/preparations into the EU, he is also a substance importer and may have to fulfil a number of other REACH requirements for these substances, including registration requirements under
Article 6 of REACH, unless as indicated above his supplier outside the EU has appointed an only
representative to fulfil the importer obligations.

2 Explained further in Section 2.2.

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GUIDANCE FOR ARTICLESIn general, companies are advised to identify their roles and check their obligations by running theNavigator on the web-site of the European Chemicals Agency, where other final guidance documents can also be found.
Non-EUEU

Article producer& Article supplier

Article importer
Non-EU
Article&Producer/supplier
Article supplier

ArticleArticle importer
Article supplier

Article distributor
retailer& Article supplier
ArticleNon-EU

Figure 1

EU

Article suppliers: producers, importers and distributors of articles

When determining if and which requirements apply, the first step is to check whether the produced
or imported objects are considered articles or substances/preparations under REACH.

1.2

Why this guidance is needed and how to use it

The specific aim of this guidance is to assist suppliers of articles in assessing which requirements
have to be complied with related to the production, import and supply of articles. It provides guidance for answering the following questions:!

Do I need to pre-register and register substances under REACH?

!

Do I need to notify substances in articles under REACH?

It guides article suppliers (including producers and importers) to answer the question:!

Do I need to forward information on substances in the articles to my customers?

The workflow in Section 6.1 directs the user of the guidance to the chapters which are relevant inrelation to these requirements.

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GUIDANCE FOR ARTICLES
However, it is advised to first read the general guidance on issues relevant for all actors covering:!

Overview of requirements for substances in articles and related requirements (Chapter 2)!

Guidance on what is considered to be an article (Chapter 3)!

Communication about substances in the supply chain (Chapter 4).

!

Chemical analysis as an option to identify and quantify substances in articles (Chapter 5)

The Appendices provide further information and examples.

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GUIDANCE FOR ARTICLES2REQUIREMENTS FOR SUBSTANCES IN ARTICLES UNDER REACH

Four types of requirements exist for producers, importers and other suppliers of articles: to register(1) or notify (2) substances contained in articles to the Chemicals Agency, to communicate specificinformation related to the content of some specific substances to the customers (3) and to comply
with any community wide restriction (4). These obligations only apply under certain conditions,which are specified in Article 7, 33 and the entries in Annex XVII of REACH. Article suppliers,
which are only supplying (i.e. not themselves producing or importing the articles), only have tocomply with Article 33.
The following parts of REACH are of particular relevance for producers, importers and other suppliers of articles:!

Article 3(3): Article definition.

!

Article 7: Registration and notification of substances in articles. Defines under which circumstances article producers and importers are to register or notify (see sections 2.1 and 2.3).

!

Article 23, 28-30: Deadlines for pre-registration and registration of phase-in substancesand participation in Substance Information Exchange Fora (SIEF). Article producers andimporters who have to register substances intended to be released should make a pre-registration
to benefit from the transitional provisions for phase-in substances.

!

Article 57 and 59: Criteria for substances of very high concern (SVHC) and procedure for how
they are placed on the candidate list.

!

Article 33: Duty to communicate information on substances in articles. Producers, importers and other suppliers of articles containing substances on the candidate list may have to forward required information available to them down the supply chain (Article 33(1) and to consumers on request (Article 33(2)).

!

Annex XVII listing the conditions of restrictions, which may pertain to certain substances in
produced and imported articles.

Substances being (an integral) part of imported articles cannot be subject to authorisation. However,
if an EU-based producer of an article incorporates a substance as such or in preparation into thearticle, that use of the substance may have to be authorised (if the substance is listed in REACH
Annex XIV). If such a substance is acquired from the EU market, the supplier has to give this information in section 16 of the safety data sheet or via information according to article 32. If the article
producer imports such substances himself, he has to apply for an Authorisation for continued use.
Details on the Authorisation procedure, notifying the use of authorised substances etc. can be foundin the Guidance for Downstream Users (Chapter 12 on authorisation), Guidance on Annex XIV inclusion (substances subject to authorisation) and the Guidance on authorisation application.
As already noted, producers of articles using substances/preparations may also have other importer
and/or downstream users obligations under REACH.
In general, it may be helpful for article producers/importers/suppliers to understand more of theoverall legislative system, e.g. to understand the possibilities of obtaining information in the supply
chain and to get a full overview of their REACH obligations. Please refer to the web-site of the

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GUIDANCE FOR ARTICLESEuropean Chemicals Agency (http://ec.europa.eu/echa/) for further general information on REACH
and the roles and obligations of the various actors.

2.1

Registration according to Article 7(1) (and 7(5))

A registration (Article 7.1) of substances in articles is obligatory for an article producer or importer
only if the following conditions are met:!

The substances are intended to be released from the produced or imported article(s) during normal and reasonable foreseeable conditions of use!

The total amount of the substance present in the articles with intended releases produced and/or
imported by that actor exceeds 1 tonne per year per producer or importer.

The amounts intended to be released as well as the amounts which are not (intended) to be released
need to be taken into account. Furthermore, if more than one type of article with intended release isproduced/imported, the quantities of that substance in all articles with intended releases have to besummed up 3.
The amounts of the same substance produced or imported as such or in preparations do not have tobe taken into account, as they would be covered by registration obligations under Article 6 of
REACH.
Even if the above criteria are met for a substance in an article, the substance does not have to beregistered by the article producer or importer if it has already been registered for that use (Article
7(6)). Guidance on this is provided in Chapter 9.
If an article producer or importer has to register a substance, he should also make a pre-registrationin order to benefit from the later registration deadlines of the phase-in scheme (see Section 2.5 andthe Guidance on pre-registration and Guidance on registration for further information). It will befurther explained in Section 2.5, why a producer/importer who thinks that the substance intentionally released from his article will at a later stage be registered for his use (and therefore he will atthat point in time be exempted from registration via Article 7(6)), should also seriously consider
pre-registration.
According to Article 7(5), the Agency may decide that an article producer or importer must submit
a registration for any substance contained in an article if the amount of the substance exceeds 1
tonne per year and if there is a suspicion that the substance is released from the article resulting inrisks to human health or the environment. This may apply to any substance which has not yet beenregistered for that use under Article 6 or Article 7.1 (see Chapter 9).

3 Example: If a company X imports three articles A, B, and C with 60 tonnes of the substance present in each but: inarticle A, the substance is not intended to be released, in article B, 40 out of 60 tonnes are released under normal conditions and in article C 10 out of 60 tonnes are released under normal conditions, the company X will need to register the
total volume of the substance in article B and C: 120 tonnes, i.e. in the 100-1000 tonnes band.

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GUIDANCE FOR ARTICLES
Notification according to Article 7(2) 4

2.2

Notification of substances in articles is required when all conditions of Article 7(2) are met:!

The substance is included in the candidate list 5 for authorisation (Article 59(1)) and!

The substance is present in all articles produced or imported by one actor in an amount totalling over 1 tonne per year (per producer or importer)!

The substance is present in articles above a concentration of 0.1% weight by weight (w/w)

If, however, one or both of the following conditions are met, no notification is required:!

The producer or importer can exclude exposure of the substances to humans or the environment
during normal or reasonable foreseeable conditions of use including disposal (Article 7(3)).

!

The substance has already been registered for that use according to Article 7(6) (see Chapter 9).

The substance concentration threshold of 0.1 % (w/w) applies to the article as produced or imported. It does not relate to the homogeneous materials or parts of an article, as it may in someother legislation, but relates to the article as such (i.e. as produced or imported).
Only substances with specific properties can be identified as substances of very high concern on thecandidate list for authorisation. The properties are defined in Article 57 and include substances
which are: carcinogens, mutagens or toxic to reproduction (CMRs category 1 and 2), persistent,
bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) or for which
there is evidence for similar concern. Inclusion of substances in the candidate list is preceded by aformal procedure (see Guidance on Annex XIV inclusion).
The obligation to notify substances in articles also applies to packaging materials, which may be
produced or imported separately as packaging of imported goods. Packaging is to be assessed separately from any object it contains.
A notification is not required for a substance in articles which have been produced or imported before the substance has been included on the candidate list for authorisation.

2.3

Obligations according to Article 334

The aim of Article 33 is to ensure that sufficient information is communicated with articles to allow
their safe use.
Producers, importers and other suppliers of articles containing substances of very high concern(SVHC) included on the candidate list for authorisation in a concentration above 0.1% (w/w) haveto provide respective information available to them to the recipients6 of the articles and as a mini4 Dissenting views (http://reach.jrc.it/docs/guidance_document/dissenting_en.pdf), questioning the application of the

0.1 % threshold to the entire article have been notified by 6 Member States (Austria, Belgium, Denmark, France, Germany and Sweden) and publication of this part of the guidance document was not endorsed by these Member States.
5 A separate list will be established according to the procedures of Article 59 with substances which are identified as

candidates for the authorisation procedure. This list will be published on the website of the European Chemicals
Agency.
6 Note that the term “recipients’’ does not include consumers under REACH.

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GUIDANCE FOR ARTICLES
mum the name of the substance. This information is to be provided ‘automatically’ (Article 33(1).
NB! There is no tonnage trigger for this obligation (i.e. it also applies below 1 tonne/a) and the obligation cannot be exempted neither via Article 7(3) (exclusion of exposure) nor via Article 7(6)(already registered for that use).
Information available to the article supplier necessary to ensure safe use of an article has to be provided also to consumers upon request (Article 33 (2)). Consumers have to be provided with information within 45 days of the request, free of charge.
As for the article 7(2) requirements, the substance concentration threshold of 0.1 % (w/w) applies tothe article as produced, imported or supplied.
For example, if imported buttons for jackets contain such substance in concentrations of 0.5%(w/w), this needs to be communicated to the recipient. If these buttons are imported as part of jackets the concentration of the substance in relation to the imported article (the jacket) will probably belower than 0.1% (w/w) and in that case no information would have to be communicated.
The obligation to forward available information on substances of very high concern on the candidate list also applies to packaging materials. This packaging material is always a separate ‘article’.
Thus, if the imported buttons or the imported jackets were packaged in plastic packaging material,
the content of such substances in this packaging material would have to be assessed separately.
The obligation to provide available information on substances of very high concern to the recipientsof the articles applies as soon as a substance has been included on the candidate list for authorisation. The obligations also apply to articles which were produced or imported before the substance
was included on the candidate list and are supplied after the inclusion. Thus, the date of supply of
the article is relevant.

2.4

Restrictions

Restrictions (Annex XVII): The content of substances in articles can be restricted or banned under
the restrictions procedure. Article producers and importers have to follow the conditions outlined in
Annex XVII of REACH from June 1, 2009. Until then, the directive on marketing and use of dangerous substances (76/769/EC) is still in force. Details on compliance with restrictions are given in
the Guidance for Downstream Users (Chapter 13). Further detailed guidance will not be given inthis guidance document.

2.5

Timelines under REACH

Substances intended to be released from articles under normal or reasonably foreseeable conditionsof use are to be registered under Article 7(1) by the same dead-lines that apply to substances as suchor in preparations to be registered under Article 6. Also, the same distinction between phase-in substances and non-phase-in substances applies 7.

7 Phase-in substances are defined in Article 3(20) as substances meeting one of the following criteria (simplified, fordetails see legal text or Guidance on Registration, Section 1.7.1): a) listed in the European Inventory of Existing Commercial Chemical Substances (EINECS) or b) manufactured in the EU but not placed on the market since June 1, 1993or c) substance is a no-longer polymer. All substances not meeting these criteria are non-phase-in substances. For further information, please consult the Guidance on Registration.

17

GUIDANCE FOR ARTICLESThe obligation to register substances in articles applies from 1 June 2008. However, for preregistered substances the transitional registration deadlines of the phase-in scheme apply. Phase-in
substances can be pre-registered 8 in the period between 1 June and 1 December, 2008.
NB! Important in relation to Article 7(6). At the time of pre-registration, few substances will already have been registered. Therefore, a producer/importer of an article with an intended release of
substances should seriously consider pre-registering. If he does not pre-register and if the substancehas not (yet) been registered for his use, he has to cease his production/importation until he has
made a registration as his substances would be considered a non-phase-in substance, or until someone else registers his use (which may take several years)! Please note that the pre-registration dossier is a rather limited dossier.
An article producer/importer who has pre-registered will become member of the Substance Information Exchange Forum (SIEF) for that substance. This may assist in finding another actor who
registers the use in the article and thereby trigger that the article producer/importer can use the Article 7(6) exemption. Otherwise, the article producer/importer will himself have to register. Further
guidance on 'registered for that use' is given in Chapter 9 of this guidance. Note that becoming a
SIEF member may entail obligations related to data sharing. Information on SIEFs can be found in
the Guidance on data sharing.
A non-phase-in substance intended to be released from articles has to be registered after 1 June2008 and before the article is placed on the market. An inquiry has to be made to the Agency toidentify if information is available on the substance that could be shared.
A notification of substances in articles shall be made at the latest 6 months after it has been included
on the candidate list for authorisation but only starting from 1 June 2011. Information on substances on the candidate list contained in articles is to be forwarded to the recipients of article directly after a substance is included in that list. The candidate list will be updated continuously whensubstances have been identified as meeting the criteria of Article 57. Table 1 summarises the deadlines relevant for article suppliers.

8 Separate guidance is available on pre-registration and data sharing.

18

GUIDANCE FOR ARTICLESTable 1 Timelines for article suppliers
Potential obligations for article suppliersTime

Start of obligation to register non-phase-in substances and phase-in substances
which have not been pre-registered, if conditions of Article 7.1 are met

From 1 June 2008

Pre-registration of phase-in substances if they need to be registered according to
Article 7.1 or according to Article 6 (e.g. substances imported in preparations)

1 June 2008 – 1 December 2008

Participation in SIEFs (potential registrants according to Article 6 and 7.1)

1 June, after pre-registration 9

Communication regarding substances on the candidate list in articles according
to Article 33

After publication of candidate list
(first list expected autumn 2008 /beginning 2009)

Notification of substances in articles according to Article 7.2

6 months after substance is included in candidate list. No notification required before 1 June 2011

Registration of pre-registered phase-in substances

By 30 November 2010!

in amounts ! 1000 tonnes per year or more,!

in amounts ! 1 t/a if the are known carcinogens, mutagens or reprotoxic substances (category 1 and 2) and!

in amounts ! 100 t/a substances if they are classified with R50/53

10

Registration of pre-registered phase-in substances in amounts between 100 and1000 tonnes per year

By 31 May 2013

Registration of pre-registered phase-in substances between 1 and 100 tonnes per
year

By May 2018

2.6

Other relevant legislation

The restrictions on the marketing and use of certain dangerous substances and preparations 11 in the
Annex I of Directive 76/769/EEC will be repealed on 1 June 2009 and included in Annex XVII of
the REACH: “Restrictions on the manufacture, placing on the market and use of certain dangerous
substances, preparations and articles”. This means that existing restrictions, such as the ban of certain azo-colorants in textiles, will continue to apply.
Other legislation concerning restrictions, reducing the use of or the risks from hazardous substancesin articles still apply separately from REACH. Examples are the General Products Safety Directive
2001/95/EEC and product specific legislation such as Directive 2002/95/EC on the Restriction of
the Use of certain Hazardous Substances in Electrical and Electronic Equipment (RoHS), Directive
88/ 378 on toys or Directive 2000/53/EC on End of Life Vehicles (ELVs). A list of relevant legislation is provided in Appendix 7 of this guidance.

9 After pre-registration is accepted access to a dedicated website for the same pre-registered substance is granted; SIEFs

must be formed by pre-registrants themselves.
10 Provided as harmonised classification in Annex 1 of Directive 67/548/EEC or as result of self-classification.
11 consolidated text: CONCLEG: 1976L0769 – 16703/2004

19

GUIDANCE FOR ARTICLES
2.7

Packaging and containers

Substances, preparations and articles can be contained inside of packaging. This packaging, be it acarton, a plastic wrapping or a tin can is considered as article under REACH. Similarly, the cartridge of a toner is regarded as an article under REACH. The packaging material does not belong to
the substance/preparation or article being packaged. Producers/importers of packaging or of packaged substances, preparations or articles have to fulfil the same requirements for that packaging as
for any other article. Packaging with different functions needs to be considered separately (e.g. if anarticle is directly wrapped in plastic and then packed in cardboard boxes, the plastic and the cardboard box should be considered separate articles.)Normally 12 there is no intended release from packaging materials. There may be exemptions, e.g.
packaging releasing corrosion inhibitors. In this case the release is intended (the function is to prevent corrosion) and constitutes an accessory function of the article (the main function is to protect
the object contained inside the packaging from any damage during transport and storage). For further guidance see Chapter 3.

2.8

Documentation

There are no specific record-keeping requirements for Article 7 or Article 33 of REACH for article
suppliers except for those needed when registration, notification or communication are required.
However, article suppliers may also be suppliers and users of substances or preparations and in relation to these roles shall assemble and keep available relevant information for at least 10 years (Article 36 of REACH).
Article suppliers should consider documenting the results of their compliance checking, even when
it has been identified that no obligations under REACH exist. Documentation facilitates demonstrating REACH compliance towards customers and (inspecting/enforcing) authorities.
It is recommended that each producer/importer establishes routines to ensure high quality documentation. Possible approaches could be:!
!

Article suppliers with implemented management systems could incorporate REACH conformity
as a criterion – with clear indications of how conformity will be secured and documented.
Article suppliers without a management system may follow a kind of “good practice for supplying articles”, which could be developed by the respective industrial associations. This might include:! Following the workflows of this guidance! Describing whether registration/notification or communication on SVHC is required! Supporting documents including letters from suppliers, certificates, results of analysis etc.

12 Known cases of packaging material from which substances or preparations are released are metal wrapping contain-

ing anti-corrosion agents.

20

GUIDANCE FOR ARTICLES

3DECIDING WHAT IS AN ARTICLE UNDER REACH"Article means an object which during production is given a special shape, surface or design which
determines its function to a greater degree than its chemical composition;" (REACH, Article 3(3)).
In a general understanding, an article is an object composed of one or more substances or preparations given a specific shape, surface or design. It may be produced from natural materials, such as
wood or wool, or from synthetic ones, such as polyvinyl chloride (PVC). Substances or preparations may be added to give an article its special properties. Most of the commonly used objects inprivate households and industries are articles, e.g. furniture, clothes, vehicles, books, toys, kitchenequipment, and electronic equipment. In order to determine whether or not an object fulfils thedefinition of an article under REACH sometimes a deeper assessment of an object’s function and its
properties is needed.
An article is to be understood as the article as produced or imported. It may be very simple, like awooden chair but could also be rather complex, like a computer, consisting of several parts, which
are also considered articles when produced or imported 13. It may be particularly difficult to decide
if an object is an article or if it is a substance or preparation when assessing different stages in raw
materials processing. Furthermore, when substances or preparations are enclosed in an object it may
be difficult to decide if they are to be considered an integral part of an article (like e.g. the liquid ina thermometer) or if they are not an integral part of an article (for example an aerosol in a spray can,ink in a printer cartridge). In these cases, the elements of the article definition in the sections below
should be looked at in more detail, including the essential and decisive elements of the article definition. Appendices 2 and 3 contain examples of borderline cases illustrating the decision making
process.

3.1

The function of an object

The function of an object, which may or may not be an article, is determined by what its producer /supplier wants it to be used for and what the person acquiring it expects it to do. For many objects
there is no doubt about what their function is, for example the function of scissors is to cut, thefunction of brooms is to sweep, the function of a radio is to receive and amplify the programme of
the radio station etc. The function is thus either obvious or could be evidenced by the object’s labels, use instructions etc.
If it is difficult to decide whether or not an object is an article it may be necessary to further analyse
what its function is: The function refers to the basic principle determining the use of the object. It
may be helpful to define the result of using an object to identify its function and pay less attention
to the quality of the result. For example, the principle behind a printer cartridge is to bring ink onto
paper. A higher degree of technical sophistication of the object ‘printer cartridge’ may improve thefunctioning and the quality of the result but it does not change the function as such.
Further considerations on the function of articles are given in Section 3.3.2.

13 Dissenting views (http://reach.jrc.it/docs/guidance_document/dissenting_en.pdf), questioning the application of the

0.1 % threshold to the entire article have been notified by 6 Member States in writing (Austria, Belgium, Denmark,France, Germany and Sweden) and publication of this part of the guidance document was not endorsed by these Member States.

21

GUIDANCE FOR ARTICLESFor these reasons, the term “function” in the article definition should be interpreted as meaning thebasic principle determining the use of the object rather than the degree of technical sophistication
determining the quality of the result.

3.2

The shape, surface and design of an object

The elements shape, surface and design represent the physical appearance of an article and can beunderstood as other than chemical characteristics. Shape means the three-dimensional form of an
object, like depth, width and height. Surface means the outmost layer of an object. Design means
the arrangement of the ‘elements of design’ in such a way as to best accomplish a particular purpose. The design of a textile may be determined by the twist of fibres in the yarn, the weave ofthreads in a fabric and the treatment of the surface of the textile.
An object may be built up with a high level of sophistication of these characteristics. Nevertheless,characteristics simply improving the function of an object but not as such changing the function
should not be overestimated for the reasons explained in section 3.1.

3.3

Workflow for deciding if an object is an article or not

The workflow provides guidance on deciding if an object is an article or not. It assists in deciding if
an object is an article or not in particular when there are doubts concerning:
1) The borderline in the sequence of processing natural or synthetic materials to final articles,in particular deciding on 'semi-finished products'
2) The borderline between substances/preparations in special containers / on special carrier material and substances/preparations being (integral) parts of an article

22

GUIDANCE FOR ARTICLESObjectIn answering this question, consider
the object as a whole, including a
potential chemical content (like e.g.
in a battery or liquid thermometer).

No

What is the intended function of theobject, what do you expect it to do
under normal conditions of use?

Identify the function of
the object

Isthe chemicalcomposition more relevant
for the function thanshape, surface anddesign ?

Yes

The object is a
substance orpreparation

The object isan article

Cannot decide, don’t know
Continue inthisguidance

Doubts,because object is raw
material underprocessing?

Obligations as
M/I and/or DU

Yes

Apply separate list of criteria in
Section 3.3.1 and look at
examples in Appendix 3

Yes

Apply separate list of criteria in
section 3.3.2 and look at
examples in the Appendix 2

No
Doubts,because chemical
content can be separated
from main
object ?
No
Look at Appendix 2 and 3 and identify similar objects. Discuss with yoursectors and if necessary, ask for advice from the national helpdesk
Decide and document
decision criteria

Figure 2
3.3.1

Decision taking on the article definition

Borderline in the sequence of processing natural or synthetic materials to final articles

When materials are processed, there is a certain point in the processing, where they change frombeing a substance/preparation to being an article. In some cases there may be doubts on when exactly this transition occurs. The following approach should be seen as decision help in support of
the application of the article definition when deciding on these types of cases. The following steps
may be taken:
As a general principle, the article definition should be applied, which is a two step process:1. Determine the function(s) of the material by assessing the technical features of the material
in relation to the intended function by the seller as well as the buyer of the material.
2. Decide on what is more relevant for the function, the shape/surface/design or the chemicalcomposition
If you can unambiguously conclude that the shape/surface/design are more relevant for the function
than the chemical composition, the (form of the) material that you are assessing is an article. If the
shape, surface or design is of equal or less importance than the chemical composition, it is a substance or preparation.

23

GUIDANCE FOR ARTICLESIn this respect it is however always important to recall the basic requirement given in the definitionof an article, cf. Art. 3(3), that the shape, surface or design of the material in question must be deliberately determined and given during production.
If you are in doubt, you may use the following indicative questions in order to better determine
whether or not the material is an article. These questions can only be used to support the evaluationof the importance of the chemical composition versus the shape/surface/design in relation to thefunction and thus facilitate the application of the article definition to raw materials.
Not all questions may apply to all raw materials and processes and the weight of evidence of theanswers to the questions may vary from case to case. It is also possible that some answers are contradictory. In concluding whether the raw material is an article or not, the various relevant indications should be considered and not only one question or consideration.
! Does the material in question have a function other than being further processed?
If the material predominantly has other functions (i.e. end-use functions), then this may be
an indication that it is an article according to the definition of REACH.
! Does the seller place the material on the market and/or is the customer mainly interested inacquiring a material because of its chemical composition or its shape/surface/design?
If the material is mainly put on the market or acquired because of its shape/surface/design,
this is an indication that the material is an article.
! After which processing step is the function determined to a larger degree by theshape/surface/design (e.g. polymer pellet is converted to film)?
A comparison of the material’s properties and general shape before and after the different
processing steps may be helpful to identify the transition point.
‘Light processing’ such as drilling, grinding or bending may improve or modify a material’s
shape, surface or design for carrying out a function and is thus frequently applied to materials which are already articles.
! Does the chemical composition of the material as such remain similar in the next processing
steps as a change may indicate the material being a preparation?
The fact that the chemical composition of a raw material is significantly changed, e.g. additives are added to a polymer, may be an indication that the material is still a preparation. Itshould be noted however that the fact that a given material in itself does not change its
chemical composition and properties cannot be used as an indication of the material being
an article. Surface treatment of raw materials which are articles may result in a change in its
overall chemical composition, however not in the status of the material being an article. Examples are printing onto the surface, painting, applying coatings, etc. Some finishing otherthan surface treatment may change the chemical composition, but not the status of the material being an article, e.g. dyeing of fibres.
Examples are given in Appendix 3.

24

GUIDANCE FOR ARTICLES

3.3.2

Borderline between substances/preparations in special containers / on special carriermaterials and substances/preparations being (integral) parts of an article

An object may consist of!

a special container or a special carrier, which is normally a solid material and may be constructed as very simple or highly sophisticated objects and!

solid, liquid or gaseous substance(s) and/or preparation(s), which could be (integral) partof an article.

For determining whether the chemical content of an object is an integral part thereof (and therefore
the object as a whole is an article as defined under REACH) or if it is a substance / preparation forwhich the rest of the object functions as container, a closer examination is necessary.

25

GUIDANCE FOR ARTICLESExplanation on the steps is given in
the text following this figure

ObjectIdentify the function of the object (Section 3.1)

Is thefunction mainly todeliver a substance /preparation?

YES

Step 1

Obligations as
M/I and/or DU
Container isarticle!

Object is substance orpreparation in special
containter / carrier

Step 2NO
Is themain purpose related
to a substance / preparation contained in
the object?

YES

Check indicative questionsin the explanation
Step 4

Step 3

Questionsanswered with ‚YES’
rather than ‚NO’?

NO

Does thechemical content of theobject contribute to anaccesory function?

YES

NO

YES

NO
Cross check with additional
indicative questions in the
explanation
Step 5

Analyse main function of
the object further

Questionsanswered with ‚YES’
rather than ‚NO’?

NO

YESContinue in
Chapter 6 of thisguidance

The object is an article with
substances / preparations as
integral parts

The object is a
substance or preparation
in a special containtercheck obligations

Figure 3 Deciding on borderline between substances/preparations in special containers /carrier materials or as integral part of articles
M = manufacturer of substances; I = importer of substances; DU = downstream user

Explanation to the workflow:
Step 1: Define the function of the object in line with section 3.1.
Note that the degree of technical sophistication of an object’s shape, surface or design may make it
difficult to decide on what is more relevant for the proper functioning of the article. Even thoughthese elements may improve the quality of the object, they frequently do not determine the function

26

GUIDANCE FOR ARTICLESof the object. Therefore, the shape, surface or design should not be overestimated, as they are often
not more decisive for the function of the whole item than the chemical composition of the contained
substances/preparations.
Step 2: If the function of the object is mainly to deliver a substance/preparation, then this substance/preparation and its chemical composition is generally more important for the function thanthe container that delivers the substance/preparation. Therefore, the chemical composition of thesubstance/preparation determines the function of the object to a greater degree than its shape, surface or design, and the object is a substance/preparation in a special container or on a special carriermaterial. The container or carrier material functions as ‘packaging’ for the chemical content andmay be constructed in a quite sophisticated way to control or target its ‘delivery’. However, it is thesubstance/preparation that matters most when the actual function takes place ‘outside’ the object,even though the container may be very important for the quality of the function and the convenienceof handling the object.
If this consideration gives a clear answer, there is no more need to go through the further steps.
Step 3: If the main purpose of the object is not related to the substance/preparation under consideration but to another function, then the object should be analysed on the basis of its main function.
This is e.g. the case for a perfume in a perfumed textile, e.g. a towel. Here, the main function is notreleasing the perfume but to dry a person. Therefore, the further analysis needs to focus on whether
the towel as such is a preparation or an article.
If the result of this analysis is that the main object is an article, the substance/preparation referred toabove may still have as an accessory function an intended release (e.g. releasing perfume from aperfumed towel).
Step 4: If the main purpose of the object is related to the substance/preparation under consideration
but there are still doubts on whether the object as such is a substance/preparation or an article, thefollowing questions may lead to clarification:
Question 4a: If the substance/preparation were to be removed or separated from the object andused independently from it or changed from the object to a similar type of object, would the substance/preparation still be capable in principle (though perhaps without convenience or sophistication) of carrying out the intended purpose of the substance/preparation 14?
Question 4b: Does the object act as a container or carrier for release or controlled delivery of
the substance/preparation or its reaction products?
Question 4c: Is the substance/preparation predominantly consumed during the use phase of theobject or eliminated or in any other way outside the object at the end of useful life, i.e. before
disposal?
If you can answer these questions with ‘yes’ rather than ‘no’, then the object should be regarded asa special container / special carrier material with substances / preparations contained within. Thismeans that the substances as such or in the preparation may have to be registered 15 under Article 6

14 Function as described in section 3.1.
15 Registration would be required by the article supplier only if the object is imported and the substance amounts con-tained exceed 1 t/a.

27

GUIDANCE FOR ARTICLESof REACH and that the container / carrier material itself is an article and obligations under Article
7(2) and Article 33 need to be complied with.

Example 1

Substances / preparations in a container - Toner Cartridge

Example: Toner cartridge
Answering the above indicative questions: 4a) if the toner was moved from the cartridge, it would still be possible to bring it to paper, although with a loss of quality and convenience; 4b) the function of the cartridge is tohold the toner in place inside a printer and it controls the speed and mode of release; 4c) the cartridge is disposedof without the toner, which is consumed during the useful life of the cartridge. The answers to the questions allow the conclusion that a toner cartridge is a special container containing a preparation.

If step 4 gives a clear answer, there is no more need to go to step 5. In case of doubts on answering
the questions 4a and 4b, it is also recommended to think of other ways how the function can beachieved to decide if this is more dependent on chemical or on physical properties.
Step 5: If the answers to step 4 are predominantly no, you can use the following questions to crosscheck whether the object should indeed be considered as an article and not as a substance/preparation in a special container. Please note that these questions should not be used as
stand-alone questions before having gone through steps 1 to 4.
Question 5a: If the substance/preparation were to be removed or separated from the object or
exchanged for a similar type of substance/preparation, would the object be unable to fulfil its
intended purpose?
Question 5b: Is the main purpose of the object other than to deliver the substance/preparation
or its reaction products?
Question 5c: Is the object normally discarded with the substance/preparation at the end of useful life, i.e. at disposal?
If you can answer these questions with ‘yes’ rather than ‘no’, then the function of the object islikely to be determined by the physical properties shape, surface and design, than by the chemicalcomposition. The object is then regarded as an article and its chemical content as an integral part
thereof. In this case it must be checked if obligations under Article 7 and Article 33 apply.

28

GUIDANCE FOR ARTICLESExample 2

Substances/preparations on a carrier material - wet wipes

Example: Wet wipe with a cleaning liquid in it
The function of wet cleaning wipes is to remove dirt from surfaces. The cleaning effect could generally beachieved by using the same preparation with another type of wipe (e.g. a normal household wipe). This is inprinciple a clear result. However, if in doubt, one could also ask the question the other way round and compare
whether the wipe alone would achieve the same result. In this case it is considered that it would be easier toachieve the desired result with the same preparation and another type of wipe rather than with the dried wipe orwith another substance (e.g. water only). Therefore, cleaning wipes should in general be considered as a special
carrier material containing a preparation.

Example 3

Substances/preparations as integral part of an article

Examples: Thermometer
Answering the above questions: 5a: The empty thermometer would fail to show the temperature; thus the object
would no longer be useful. 5b: The main function of the thermometer is to show the temperature, this is not a delivery of a substance or preparation. 5c: The thermometer is normally disposed of together with its chemical content. In conclusion, answering these questions leads to the conclusion that a thermometer (including the liquid it
contains) is an article.

3.3.3

Requirements for objects which are substances/preparations in containers

The described concept of substances/preparations in a container vs. article and the existence andapplication of clear rules for that definition may reveal that the status of some objects under
REACH may differ from a company’s current understanding of an object as an article.
In particular, substances as such or in preparations which are contained in a special container or in a
special carrier material need to follow the requirements for substances/preparations, which may include e.g.
!

Registration in accordance with Article 6 (and not 7)!

Labelling in accordance with Directive 67/548/EEC!

Obligation to notify the Agency on the classification of the substance, in accordance with
Article 113!

Safety data sheet in accordance with Article 31!

If the substances are of very high concern and included in Annex XVI of REACH, authorisation of the use in accordance with Title VII!

General restriction on the use in accordance with Article 68(2) and Annex XVII

Please refer to the Navigator on the web-site of the European Chemicals Agency to identify all relevant requirements (http://ec.europa.eu/echa/).
The definition of the status of objects under REACH does not affect legislation which is not basedon the REACH definition of articles.

29

GUIDANCE FOR ARTICLES

4INFORMATION VIA THE SUPPLY CHAIN

For article suppliers, communicating with the suppliers is the most important and efficient way togather information on substances contained in their articles. Communication along the supply chain
is one of the core instruments to ensure controlled use of substances. As stated also in the introductory clauses to REACH (the recitals), communication on substance hazards and risks as well as advice to control risks, is an important purpose of REACH. Identifying substances in articles andquantifying their amounts in order to assess whether or not these may pose a risk is in many cases
only possible if the respective information is made available by the actors in the supply chain.
Supply chain communication is therefore the most important way of gathering the informationneeded. This is due to the fact that chemical analysis, although a possible way to identify and quantify constituents of substances, preparations or articles, is time consuming, costly and difficult toorganise. However, supply chains may be complex and non-EU companies may not be prepared toprovide the information. Article importers may have to inform their suppliers outside the EU of therequirements of REACH and make special arrangements to receive information. Establishingcommunication policies and standards for substances in articles is an important task for private sectors in order to facilitate the implementation of REACH.
Information needed to check whether or not the requirements of REACH Article 7 apply can relate
to the identity of substances as well as to the amounts/concentrations in the article itself or in preparations used in its production.
The communication of the information related to substances contained in articles according to Article 33 shall enable safe use of the article and should consider the entire life cycle of the article.
What information is actually needed depends on a case-by-case assessment and is explained in therespective sections in this guidance.
Only representatives responsible for the importer requirements on behalf of non-EU article producers/suppliers have to comply with the obligations of Article 7 as well as Article 33 when these apply. Thus, they will be responsible for the upstream communication with the non-EU supplier onbehalf of the importers.

4.1

Obtaining standardised information from suppliers

EU suppliers of substances (on their own or in preparations) have to communicate information according to Article 32 or via safety data sheets. Article suppliers (producers/importers/distributors)
normally have no legal obligation to communicate information on substances contained in their articles apart from the obligation in Article 33 under REACH 16.
Some information needed to comply with Articles 7 and 33 can be derived from safety data sheets
or Article 32-information 17 of substances or preparations 18 which have been used to manufacture an

16 However care must be taken as decisions made in relation to the definition of an object being a substance/preparation
in a container which then may require classification and labelling as well as safety data sheets.
17 Information according to Article 32 is required for substances as such or contained in preparations which are subject

to authorisation or restrictions when no safety data sheet is required. Furthermore, it may be required if for such substances (other) specific risk management measures need to be communicated. Further information is provided in the
Guidance for Downstream Users.

30

GUIDANCE FOR ARTICLES
article. This information is either required to be provided, e.g. if an article producer uses the substance or preparation in his production, or could be requested from the actors up the supply chain
and normally contains information on:!

The registration numbers of the substance(s), as such or in a preparation, if registered (whensubstance volume " 1 tonne per year and per manufacturer/importer) in section 1 or in section 3of the safety data sheet or as Article 32-information.

!

The identity of the manufacturer/importer/distributor responsible for placing the substance/preparation on the EU market in section 1 of the safety data sheet or as Article 32information!

The chemical names and identification numbers of the substances in section 1 and/or 3 of thesafety data sheet or as Article 32-information!

Concentration ranges of dangerous substances in the preparation in section 3 of the safety data
sheet

!

The classification of the dangerous substance(s) and information on authorisation and restriction
where applicable in section 2 or 3 of the safety data sheet or as Article 32-information!

Important and common use(s) of the substances in section 1 of the safety data sheet!

Exposure Scenarios if the substance volumes exceed 10 tonnes per year and per manufacturer /importer including the identified use(s) for which the substances have been registered. Exposure
scenarios describe how a substance is used during its life-cycle and recommend how to control
exposure of humans and the environment. These exposure scenarios cover the incorporation of
the substance in the article and the resulting life-cycle stages of the substance, including the service life of the article and the waste life-cycle stage, as relevant. Therefore the information they
contain can be useful to prepare the information to be provided to customers to allow safe use of
the article (See also Guidance on information requirements and chemical safety assessment).

As previously noted, an article producer importing substances (on their own or preparations) has
registration obligations for these substances. This way he will generate relevant information for
those substances in case they are incorporated into an article.
Article suppliers acquiring articles within the EU will normally receive the relevant information for
substances in those articles.
Article importers will not receive any comparable standardised information together with the imported articles. In order to be able to check compliance with REACH, they therefore have to generate information and communication should be initiated with the non-EU suppliers as soon as possible.

4.2

Requesting non-standardised information up the supply chain

In many cases either no or insufficient information will be supplied to article producers, importers
and other suppliers to check if the requirements of Article 7 and 33 apply to them and to implement
18 A safety data sheet is required for substances and preparations which are classified as dangerous as well as undercertain other circumstances apply (see REACH article 31). However, frequently safety data sheets are also supplied for
non-classified substances and preparations.

31GUIDANCE FOR ARTICLES
the necessary steps for achieving compliance. In these cases, active requests for information on theidentity of substances and on the concentrations/amounts contained in preparations or articles willneed to be made. It is acknowledged that supply chains are complex and that confidentiality or
supply contracts may to a large extent hinder communication. Furthermore, enquiring substanceidentities and/or contents will need time and resources.
EU producers, importers and other EU-suppliers of articles can take similar steps to obtain information. Table 2 shows which actors in the supply chain have what type of information on substances
and their amounts in the article. Normally only the direct supplier is known to the article producer
or importer, thus requests may have to be forwarded up the supply chain.
It is important to keep in mind, which actors in the supply chain have what information on substances as such, in preparations and in articles and what information they are required to forward totheir customers and what could be provided voluntarily. The following table gives an overview.
Table 2 Availability of information in the supply chain
Information
REACH Actor

Substance
manufacture /importer (registrant)

EU supplier ofpreparations

Relevant information that must
be provided ‘automatically’ fornon-classified substances / preparations

Relevant information that must be
provided ‘automatically’ if substance / preparation is classified

Relevant information that
may be provided on a voluntary basis

Substance name (label)

Substance name, registration number, classification, relevant registered uses

Information on the identification of a substances,e.g. composition, impurities etc.

If non-classified SVHC on candidate list ! Article 32information: registration number, specific risk management
information
Name of preparation and contact
information (label).
If SVHC(s) on candidate list arecontained above cut-off limits in
Article 14: registration numbers
and specific risk management
information

All registered uses
If above cut-off limits of Article 14:
name and registration number ofclassified substances and SVHC on
the candidate list, their concentration ranges in the preparation, risk
management measures, relevant
uses of the preparation

Identity of suppliers of
substances and preparations used to produce thepreparation.
Exact amount of substances and preparations in
the preparation

EU article
producer (usessubstances /preparations)

If SVHC(s) on candidate list inconcentrations above 0.1%, sufficient available information to
enable safe use

If SVHC(s) on candidate list inconcentrations above 0.1%, sufficient available information to enable safe use

Identification and amountsof substances / preparations included in the article
and the identity of their
suppliers

Article distributor / retailer

If SVHC(s) on candidate list inconcentrations above 0.1%, sufficient available information to
enable safe use

If SVHC(s) on candidate list inconcentrations above 0.1%, sufficient available information to enable safe use

Identity of article producer

Only representative or
article supplieroutside the EU

If SVHC(s) on candidate list inconcentrations above 0.1%, sufficient available information to
enable safe use

If SVHC(s) on candidate list inconcentrations above 0.1%, sufficient available information to enable safe use

Identity of article producer

Producers, importers and only representatives of articles with intended release of substances may
have to register these substances; including non-classified substances. They need to know the identity and amount/concentration of all substances intended to be released from that article as well as
the total amount contained in that article and all other articles intentionally releasing that substance32

GUIDANCE FOR ARTICLES(See also Section 2.1). In order to benefit from the deadlines for phase-in substances, preregistration is required (see further details in section 2.5).
Producers and importers of all articles, including those with intended release, need to know if and inwhat concentrations substances on the candidate list for authorisation are contained in the article.
!

Article producers using substances and preparations as well as articles for their production, will receive respective information in safety data sheets, as Article-32-information oraccordance with Article 33(1) from their EU suppliers. Information on the exact concentration / amount may have to be requested.

!

Importers of articles and only representatives will not automatically receive this information but have to actively ask for it.

33

GUIDANCE FOR ARTICLESFor obtaining information through supply chain communication, various approaches can be taken:
1) Information can be requested for specific articles produced and on a case-by-case basis. Normally this would be done when there is a clear idea that requirements would apply and what type of
information would be needed. This communication would most likely be direct (phone, meeting)and supported by letters or questionnaires.
2) Information can be requested in a standardised form (e.g. questionnaire) from all actors up the
supply chain. The request should be targeted using cut-offs for amounts and specifying what information is needed and what isn’t. This request could be used e.g. to identify the registered uses ofsubstances/preparations used in the article or to find out, whether or not certain substances are used
at all.
3) To avoid complex communication via several actors, the suppliers could be identified individually to obtain information.
4) Excluding the use of substances is another way of ‘obtaining’ information on the non-existenceof substances in articles. This exclusion could be done ‘top down’, when suppliers provide certificates that substances are not used or remain under certain concentrations in articles. Another option
is to include respective criteria in supply contracts ‘bottom up’.
Which option is the most effective and works best will depend on the specific cases and further
types of communication may be necessary.
Suppliers of preparations and articles are not required to provide information on non-dangerous
substances or on precise amounts used therein. They may also be reluctant to invest their resources
or may themselves have suppliers which are not willing to co-operate. Sometimes it is possible torephrase or target an information request in a way that suppliers can answer it without having todisclose confidential business information or to be involved in extensive communication.
There may however be cases where supply chain communication will not be successful. In thesecases other means of identifying the substance(s) may be used, such as a combination of publicly
available information in databases, branch knowledge and conclusions from chemical analysis.

34

GUIDANCE FOR ARTICLES

5CHEMICAL ANALYIS OF SUBSTANCES IN ARTICLES

Theoretically, substances contained in articles can be identified and their concentrations quantified
by applying analytical methods. If other approaches to obtaining information fail or become toocomplicated, conducting chemical analysis may thus be a ‘last resort’ for checking/fulfilling
REACH obligations in relation to the identity and the content of substances in an article. Chemical
analyses may yield ambiguous results and/or be very costly and is thus, as already indicated in
Chapter 4 not recommended as the preferred instrument for obtaining information. Difficulties related to chemical analysis of substances will be faced relating to the following issues and have to be
kept in mind in case chemical analyses are conducted:!

Sampling of articles: articles may be very complex and composed of different parts andmaterials. It is therefore difficult to create a sample that represents the article for the
analysis!

Extraction of substances from the article: substances which are included in the article matrix may have to be extracted from it.
i. This may result in chemical reactions that could ‘create’ substances which do
not exist in the article
ii. The extraction may not be exhaustive, thus the full content of substances in
the matrix may not be obtainableiii. In case substances intended to be released are extracted, they cannot always
be distinguished from substances which are not intended to be released andare part of the article matrix!

Analytical methods: various methods are available to screen for the existence and identify
different substances in a sample.
i. Measurements in most cases will identify the chemical compounds/components in the sample but not necessarily 'the substance', which
has originally been used to produce the article. Note that substances may
consist of several compounds/components (see Guidance on substance identification).
ii. The analysis may show the existence of certain elements (e.g. halogens) or
the molecular weight rather than substances.
iii. If a high variety of different substances are contained, several analyses may
be needed to identify all substances, and it is particularly difficult to assign anappropriate method if it is not clear what is being looked for.

iv. The quantification of substances requires additional measurements
Chemical analyses have to be planned carefully taking into account what information can be obtained with which methods. If an analysis is carried out, a strategy should be developed in collaboration with experienced laboratories and based on available methods. The testing strategy and interpretation of results should take into account any other available information from e.g. industry sec-

35

GUIDANCE FOR ARTICLES
tor organisations, research institutions and/or accredited chemical analysis laboratories on the article
which is being analysed 19.

5.1

Chemical analysis in the context of substance registrations

If substances are intended to be released they can in principle be separated from the article without
extraction or special methods, so taking respective samples for chemical analysis should normally
be possible.
The following steps are proposed, if analysis is regarded as necessary and helpful:!

Consult experts or sector information sources to narrow down which substances to look for(both with regard to the tonnage threshold and groups of substances). Specific requirements tosubstances in articles are often linked with standard methods for analytical control of compliance (see Appendix 5).

!

Develop a strategy for testing as a tiered process, i.e. broad screenings, narrow screenings andidentification by e.g. semi-quantitative methods!

Identify from which part of the article to sample: Separated liquids, gases or powders, extracts
from article matrix or other types of sample from the article!

Perform the chemical analysis for the identification of substances

The results of the analysis will frequently not enable the full identification of the substances whichhave originally been used and which may or may not have already been registered for that use in thearticle. This is particularly the case for multi-constituent substances and substances of unknown orvariable composition (UVCBs), as it cannot be seen which compounds have been constituents ofmulti-constituent substances or have been impurities etc. Thus, the results obtained from chemical
analysis may differ from the exact identity of substances that were originally used for producing thearticle.
It may be possible to combine the results of an analysis with other knowledge on the article to reachconclusions on the identity of substances intended to be released.
Only if the ‘original’ (registered) substances intended to be released from the article cannot be determined, the article producer/importer should identify all compounds as 100% pure substances andregister those, for which the tonnage threshold is exceeded. This may signify that the article producer/importer has to register a substance ‘for the first time’ (and therefore cannot apply Article
7(6)).

19 It should be noted that there are no formal requirements on methods and/or laboratories to use. It is up to the pro-

ducer/importer/supplier judge the appropriateness.

36

GUIDANCE FOR ARTICLESExample 4

Identification of substances intended to be released - fragranced T-shirt

Example: Fragranced T-shirt
A screening for organic compounds could be performed using e.g. GC-MS. The screening procedure would
cover a scan of a broad range of organic compounds in order to get an overview of the number and amount ofdifferent compounds. The result of the screening would be a list of substances and their concentration range contained in the gas sample. Depending on the total amount of released substances, further information on concentrations may need to be generated by further, targeted analysis for single components.

5.2

Chemical analysis of substances on the candidate list for authorisation 20

The identity of substances on the candidate list for authorisation will be known to any actor via theweb-site of the European Chemical Agency. Thus, the gathering of information from suppliers or,
as a last resort, chemical analyses can in principle be targeted at those substances on the candidate
list which are suspected to be present in the article.
Sampling of articles may cause the difficulties mentioned in the introduction to this chapter. Similarly, extraction of substances will usually be necessary, which may cause the ambiguities discussed. It is important to involve respective laboratories and experts to conduct and interpret theanalysis. The following general approach is proposed to identify whether or not substances of very
high concern on the candidate list are contained in articles:!

Narrow down the range of SVHC on the candidate list which could be present in the article andthus have to be analysed by applying common knowledge about what could possibly be present
in the article (e.g. if a gas is included in the candidate list, it can be excluded as present in many
articles), by collecting information from sector publications, product standards etc. The content
of several SVHC can probably be excluded by this step.

!

Consider whether more than 0.1 % could be present in the article. Note that 0.1% (w/w) corresponds to 1 gram/kg or 1000 ppm. Trace amount would therefore not normally exceed this concentration.

!

Exhaust options for obtaining information via the supply chain for suspected SVHC.

!

Only as a last resort, conduct targeted analysis to identify whether or not suspected SVHC arepresent

If it is identified that the concentration is above 0.1 %, it is relevant to identify the total amount (tocheck whether notification under Article 7(2) is required). If the supply chain communication cannot assist with obtaining the information necessary, the following steps could be carried out for theidentified SVHC:!

If the concentration has been established with high certainty, it is straightforward to calculate
the total amount by multiplying amount of article with the concentration. Note that amounts
have to be summed up if several articles are imported/produced that contain the same substance!

If it is just known that the concentration is above 0.1%, some calculations could be made basedon worst-case assumptions about the maximum possible concentration.

20 Dissenting views, questioning the application of the 0.1 % threshold to the entire article have been notified by 6

Member States (Austria, Belgium, Denmark, France, Germany and Sweden) and publication of this part of the guidance
document was not endorsed by these Member States.

37

GUIDANCE FOR ARTICLES!

Only conduct chemical analysis if there is still doubt about whether the tonnage could be above
1 tonne/a.

The analytical limit of detection of the SVHC, i.e. the lowest concentration of a substance which
can be accurately measured in the analysed material should be at least 0.05% when technically andeconomically feasible.
High competence in analytical chemistry is needed, and the analysis needs to be carefully plannedon a case-by-case basis to obtain a sufficiently reliable result. Branch organisations, research institutions and/or accredited chemical laboratories should be consulted.

38

GUIDANCE FOR ARTICLES6REGISTRATION AND OR NOTIFICATION REQUIREMENTS

The workflow in this section guides you through the basic questions to find out which requirements
apply in relation to the article in question. It should be noted that an article could contain substances intended to be released (which may or may not be listed on the candidate list for authorisation) and substances on the candidate list for authorisation which are not intended to be released.
Both the content of substances on the candidate list for authorisation and the intended release of
substances is to be considered. This also applies to packaging materials produced or imported together with articles.

39

GUIDANCE FOR ARTICLES

6.1

Workflow on identification of potential requirements related to articles
You are an article supplier(producer, importer or distributor/retailer)(see Chapter 3 to check if object is an article)

Check if substances are intended to be released fromNo
the article in amounts > 1 t/a(Section 6 of this guidance)
Section 6.2
Intended release of
substance above
1 t/a?

Do
you only supply
articles*?

Guidance onregistration

Yes

Yes

Check if article contains
SVHC on the candidate
list for authorisation(Chapter 8 of thisguidance)
Section 6.3

No

Check content of SVHC on candidate list
(Section 8.2 of this guidance)

Section 6.3

Concentration> 0.1% w/w?
Concentration> 0.1% w/w?

No

No further
actionNo

No further
actionYes

Communicate according to
REACH Article 33

Yes

Communicate according to Article 33(Section 8.9 of this guidance)
Check if total amount of SVHC above 0.1% w/w
exceeds 1 t/a in all imported articles(Section 8.7 of this guidance)
Section 6.3
Total
amount > 1 t/a?

No

Yes

Check notification requirement(Section 8.6 – 8.8 of this guidance)

Does thearticle contain restricted
substances (c.f. guidance
for DU)?

No

Guidance for DUs

Yes

Restrictions have to be complied with
(See guidance for downstream users)

Figure 4

Identification of requirements for substances in articles

SVHC = substance of very high concern; w/w = weight per weight; t/a = tonnes per year; DU = downstream user* "Do you only supply articles?" You should answer yes to this question if you only supply articles. If you also importor produce articles you should answer no.

40

GUIDANCE FOR ARTICLES

6.2

Substances intended to be released from the article

The intended release of substances as such or in preparations from an article normally applies to anaccessory function of an article. In contrast, if the main function of an object is to release substances or preparations, as it is the case e.g. for pens, then the object is in most cases a “substance /preparation in a special container / on a special carrier material” and not an article with an intended
release (c.f. Section 3.3.2).
If an article has an accessory function, which is achieved through the release of substances or preparations during normal and reasonably foreseeable conditions use (e.g. a scented eraser) then the release is to be regarded as intended. Consequently for these substances registration requirements
under Article 7(1) of REACH have to be checked (see Chapter 7).
Example 5

Example - releases from a scented eraser

An eraser (rubber eraser) consists of an elastic material (rubber or resin components) and additive agents such as
fillers and polishing materials. Fragrance substances can also be added to provide an accessory function of agood smell.
The fragrance substances only fulfil their function if they can be inhaled and thus it is intended that they are released.

6.3

Substances on the candidate list for authorisation

For any imported or produced article, it should be checked whether or not substances on the candidate list for authorisation are contained in concentrations triggering notification and communication
requirements under REACH (i.e. >0.1% (w/w)). Substances are included on the candidate list for
authorisation after it has been agreed by a formal procedure that they fulfil the criteria of Article 57
of REACH (substances of very high concern – SVHC). The candidate list for authorisation will be
published on the Agency's website. This list will be updated every time a decision on inclusion of a
substance has been taken. Explanation for decision-making is provided in Chapter 8; examples are
given in Appendix 4.

6.4Time of checking compliance

The time at which the article producer and importer checks compliance with the requirements ofArticle 7(1) is relevant with regard to the consequences and options he has available (see Table 1).
Potential registrants should preferably pre-register between June 1 and December 1 2008 and explore the option that other registrants in the SIEF include his use in their registration dossier (seealso Section 2.5). If an article supplier identifies a registration requirement after 1 December 2008
for substances in articles he has been producing or importing already, he cannot submit a preregistration any more and is required to submit a registration immediately / before he produces orimports the article.
If an article producer or importer intends for the first time, after 1 December 2008, to produce orimport an article with intended release of substances / preparations, or for the first time in doing so
exceeds the threshold of 1 t/a for the substances intended to be released, he may submit a preregistration even though the deadline has expired, if he can prove that he manufactures or imports
the substance(s) he needs to register for the first time (Article 28 of REACH).

41

GUIDANCE FOR ARTICLES

7SUBSTANCES INTENDED TO BE RELEASED FROM ARTICLESRegistration of substances in articles is required when all conditions listed under Article 7(1) are
fulfilled:!

The substance is intended to be released under normal or reasonably foreseeable conditions ofuse 21; thus the release of the substance carries out a function of the article!

The total amount of the substance present in all articles 22 with intended release produced or imported by one actor exceeds 1 tonne per year;

If the substance has already been registered for that use (see Chapter 9) a registration is not required(However, a pre-registration is recommended as explained in section 2.5).
As a general rule, ‘intended release’ relates to a function of an article 23. This means if the substancewere not released, the respective function (which in most cases is not the main, but an accessory
function) would not be achieved. In case of scented articles for example, the fragrance substancesneed to be inhaled in order for the article to be smelled. Substance which are released because ofageing of articles, because of wear and tear or as a result of accidents, are not intended releases, as
the release as such does not provide a function in itself. Further explanation of the term intended
release can be found in Appendix 1 of this guidance.

7.1

Workflow on checking if registration is required

The following is a tiered checking, aiming at quickly identifying cases in which registration is not
required, with as little information as possible. However, it may be more efficient to perform thesteps in a different sequence, e.g. if certain information is available. Sections 7.2 and 7.3 describe
an initial assessment, which is based on:!

The total volume of the articles with intended release produced or imported!

The total or the maximum volume of the substances/preparation incorporated in the article withintended release

If the need to register cannot be excluded, the substances intended to be released have to be identified in order to:!

check if any of the substances are exempted from registration!

check whether the substances have already been registered for that use (Chapter 9)

21 The terms normal and reasonably foreseeable conditions of use and intended release are further explained in Appen-dix 1
22 This means for determining the tonnage threshold, also the amounts a substance that are not intended to be released

need to be considered. Furthermore, the amount of that substances should be accumulated for all produced/imported
articles with intentional release of that substance. See also section 2.1.
23 Article 7(1)(b) states that “the substance is intended to be released under normal or reasonably foreseeable conditionsof use.” Both of conditions must be met. Thus, a release in an accident which is not intentional, does not trigger Article
7(1), even if it is, in some sense, reasonably foreseeable.

42

GUIDANCE FOR ARTICLES!

pre-register, join a Substance Information Exchange Forum (SIEF) and participate in joint registrations!

determine the total amount of each identified substance in the articles with intended release.
Article withintendedreleaseSection 6.2

Article level
Is thetotal tonnage of articles >
1t/a?

NO

Check SVHC
on candidate
list(Chapter 8)

Section 7.2

YES
Preparation levelFirst
screening: total amountof P > 1 t/a?
Section 7.3

Substance
intended to be released
also part of ‚main
article?

NO

NO

YES

Substance level

Identify substances intended
to be released from the article

YES

Section 7.4

Section 7.5

Exemptions fromregistration?
YES
NO

Check if substance is alreadyregistered for the use
Chapter 9

Registered?

YESNO
Determine the amount of each
substance intended to be released
Section 7.7

Total amount of
substance > 1t/a?

NO

Check SVHC
on candidate
list Chapter 8

YES
Guidance onregistration

Notify classification and labelling of substance to the C&L inventory(See guidance on GHS)

Figure 5

Workflow for checking if registration is required

P = preparation; SVHC = substance of very high concern; t/a = tonnes per year; GHS: Globally Harmonised System forClassification & Labelling

7.2

Screening at article level - checking the total tonnage of articles

If the total volume of all articles with intended release of substances produced or imported by one
actor is equal to or remains under 1 tonne per year, the volume of substances intended to be released
43

GUIDANCE FOR ARTICLES
will definitely also be below 1 tonne per year. Thus, registration of substances in the articles willclearly not apply.
If the total volume of all articles with intended release exceeds 1 tonne per year, the assessment
should be continued.

7.3

Screening at preparation level

If the total volume of all substances/preparations contained in all produced or imported articles withintended release remains under 1 tonne per year, also no further action needs to be taken. A firstscreening can be performed if either the volumes of substances/preparations in the articles with intended releases or the volumes of articles placed on the market are available.

7.3.1

Volume of substances/preparations in articles is known

If the volumes of the substances/preparations intended to be released and incorporated in those article are known, they can be summed up and compared to the tonnage threshold. These amounts are
known to those articles producers who include them into the article.
The amount of substance/preparation released can be estimated by weighing an article before andafter the release. This value can be used for a decision only if it can be excluded that further nonreleased substance/preparation is remaining in the article. In many cases it will be possible to exclude (substance function, properties and common sense) that a substance that is intended to be released from an article is also part of the matrix of that article. For example a fragrance in a scented
eraser is intended to be released from it but would not be expected to be part of the rubber matrix ofthe eraser.

The critical market volume of the articles potentially causing a registration of substances intended
to be released can be estimated as follows:
Based on the maximum content of a preparation in an article which is intended to be released, themaximum amount of articles that can be placed on the market without triggering registration obligations can be determined by a simple backwards calculation:
Volarticle [t/a] <1[ t / a ]max Conc preparation in article [%] # 0.01

Numberarticle [number/a] <or

1[ t / a ]max Conc preparation in article [ t / article]

Volarticle = tonnage of articles produced / imported
Numberarticle = number of articles
Concpreparation in article = maximum weight percentage of the preparation in the article

44

GUIDANCE FOR ARTICLESExample 6

Preparation intended to be released - smelling eraser

Example: An eraser contains a preparation with several fragrant substances which are intentionally released.
Assumption: The maximum content of the fragrant preparation, which consists of several substances, in theeraser is 20% by weight of the eraser (1) or given as 2 g fragrant preparation per eraser (2). The producer/importer of the eraser does not produce or import other articles. It can be excluded that the fragrant substance is part of the article matrix.
The maximum amount of the article not triggering the registration obligations is estimated:(1) Volarticle [t/a] <1[t / a ]= 5 t eraser/a
20 % # 0.01

(2) Numberarticle [number of erasers/a] <1 [t / a ]= 500,000 erasers/a
2 g / eraser

Conclusion: The estimation shows that as long as the article is produced or imported below 5 tonnes per year or
the number of erasers is below 500,000 per year, the amount of the fragrant preparation contained in the eraser
remains under 1 tonne per year and thus none of the substances contained in the preparation will exceed thethreshold of 1 tonne per year.
This is a minimum estimate based on the content of a preparation in one article as it was assumed that other articles were not produced or imported. However, care has to be taken if more articles, from which the same substance is intended to be released, are produced or imported. In that case, the amounts from all these articles mustbe summed up.

7.3.2

Volume of articles is known

If the market volume of the articles is known, the critical concentrations of substances in the preparations intended to be released can be derived as follows:
Knowing the total market volume of the article and the maximum amount of the preparation included in the article (assuming that only one preparation with the specific substance is used and in
one article only), the concentration limit, below which registration is not necessary, can be calculated for the substances:Max. conc. of substance in preparation [%] <1[t / a ]x 100
Vol article [t / a ] x Conc preparation [%] / 100

Volarticle = tonnage of articles produced / imported
Numberarticle = number of articles
Concpreparation = maximum weight percentage of the preparation in the article

Information requests up the supply chain can then be focused on substances exceeding the concentration calculated to be critical.

45

GUIDANCE FOR ARTICLESExample 7

Substance intended to be released - smelling eraser

Example: A smelling eraser contains a mixture of fragrances that are released during use.
Assumption: The eraser consists of maximum 15% fragrances. An importer sells 30 tonnes of these erasers on
the European market every year: The importer of the eraser does not import or produce other articles. He imports
4.5 t/a fragrances (30 t/a eraser x 15/100)
Maximum concentration of substance in the fragrance [%] <1[ t / a ]= 22%
4.5 [ t / a ]Conclusion: This means that registration is not necessary for substances contained in the fragrance below 22%
by weight. As this may not apply to all substances in the fragrance, further information has to be sought. The
supplier of the eraser can be asked by the importer whether the concentration of 22% is exceeded for any of thesubstances used in the fragrance, or any specifically know substance.

If the first screening shows that the threshold volume for registration is exceeded, the identification
process as described below should be followed.

7.4

Identification of substances intended to be released

First and foremost, the substance identities and their amounts/concentrations in preparations intended to be released should be requested from the suppliers. If you include substances as such into
articles, you should ask your supplier for the identity of these substances if it is not obvious from asafety data sheet. If you include preparations into articles, you should ask your supplier for the identity of those substances, which are contained in the preparation above the critical level (see section
7.3). If you import articles with intended release, ask respective information from your non-EU
supplier. An overview of information availability in the supply chain is provided in Chapter 4.
For the purpose of identifying whether or not a registration is needed and for pre-registering, in thefirst instance it is sufficient to know the CAS or EINECS/ELINCS number of the substances.
Communication on substance identities and quantities may be hindered by confidentiality concerns.
Therefore, it is essential that only the necessary information is requested. Furthermore, it may be
helpful to tell the suppliers why the information is needed, which may be unknown, particularly by
non-EU article suppliers.
Only if is it not possible to obtain the substance identity via supply chain communication, other approaches may be used. It may be possible to identify the substance(s) via a combination of knowledge of the article (databases, sector publications etc.) and chemical analysis (see Chapter 5).

7.5

Checking whether the substances are exempted from registration

A number of substances are exempted from registration and thus also do not have to be registered ifthey are intended to be released from articles. The substance identities including CAS or EINECS
numbers are compared with the exemptions from registration. The Navigator on the Agency website
should be used to check if any exemption applies and a registration under 7(1) therefore would not
be required.

46

GUIDANCE FOR ARTICLES
7.6

Checking for existing registration for that use

Guidance on checking if a substance is already registered for a use is given in Chapter 9. However,before December 2008, it is very unlikely that a phase-in substance has been registered. Thus respective checking only makes sense from 2009. This means that you should pre-register any substance intended to be released, which you already use or import in your articles, if you want to continue supplying these articles (see also section 2.5).

7.7

Total amount of each substance intended to be released

If you have identified that a substance may need to be (pre-)registered, you have to collect further
information on amounts to determine if / which tonnage threshold is exceeded and if so, for the preregistration you need to know the tonnage band of registration (see Table 1). Therefore, if you plan
to find other SIEF members that would register your use before you are obliged to do it (see also
Section 6.4), you only need to identify the tonnage band, not the exact amount.
To identify the total amount of a substance intended to be released, you have to sum up all amountsof that substance in all articles with intended release of that substance produced/imported within
one calendar year. Note that not only the amounts intended to be released but the total amount in
the articles needs to be considered and that all imported/produced articles releasing that substancemust be considered.
The best and most efficient method to identify the amounts and concentrations of substances assuch or in preparations is to communicate with the suppliers. To target requests, different methods
or starting points may be chosen depending on the type of information available:!

The total volume of the articles placed on the market is known and the concentration ranges ofsubstances in the preparations intended to be released or part of the article have been obtained
from e.g. supply chain, product specifications (on specific content in specific articles) or classification thresholds.

!

The exact concentration of the substance in the article can be obtained from e.g. mass balance(article producers), information through the supply chain, branches etc. or quantitative chemical
analysis.

It may be helpful to structure the information collection based on the different life-cycle stages ofthe substances intended to be released in order to target the requests in the supply chain.

47

GUIDANCE FOR ARTICLESTable 3 Requests for information in the supply chain
Item

Available information

Cut-off, targeting

Remarks

Article withintendedrelease of
preparation

Amount of articles
produced / imported.
Amount of substance/preparation
intended to be released in the article

Targeting requests upstream ! identification ofconcentrations of substances in the preparations
which would not lead to exceeding the annual
tonnage threshold

Note that amounts in all
articles have to be summed
up!

Formulatorof preparation intended
to be released andhis suppliers

Concentration of dangerous substances in
the preparation, as
well as concentrationof preparations theformulator has boughtfor use in his preparation

Substances below the concentrations communicated by the supplier.

If preparations are used in
the preparation, the identification of substances may
be quite complex. Targeting information requests isparticularly important due
to confidentiality.

Substance
manufacturer/ importer(M/I)

Substance identity andcomposition

Should only receive requests on substance identity for which registration is required

Requests for substances in the preparation
should be in the way:
Which non-classified substances are containedin concentrations > xyz % and what is the upper
concentration range.

If possible, the M/I should
be identified in person inorder to cooperate further
on information on substance identity

If the substances intended to be released are also part of the article matrix, these amounts have to be
identified as well (not included in the table).
If requesting information in the supply chain is impossible, chemical analysis may be conducted toquantify the amounts of the identified substances (see Chapter 5.1).

7.7.1

Calculation of the total amount of a substance intended to be released contained inarticlesIf the maximum content (whether or not it is intended to be released) of a preparation in an article
and the maximum concentration of a specific substance in the preparation (e.g. from a SDS delivered together with the preparation) are known, the maximum amount of the substance in the produced/imported article can be calculated. The maximum amount or volume of the substance in thearticle which is intended to be released is:
Volsubstance [t/a] = # Weightarticle [t] # (max.conc.preparation [%] # 0.01) # (max.concsubstance [%] # 0.01) # (number of article/a)If, however, the loss of preparation during production (e.g. loss through evaporation, wash out or
surplus substances) can be quantified, the substance volume to be registered may be reduced by therespective percentage, if this is the only process where the substance is included in the article.

48

GUIDANCE FOR ARTICLESExample 8

Reduction of substance volume to be registered

Example: If the producer can document that 10% of the solvent contained in a fragrance for scenting a textile
evaporates before the textile is finished, he may reduce the volume of the solvent to be registered by 10%.

If the same substance is intended to be released from different articles of one producer or importer,
the volumes of this substance in all those articles have to be summed up:
Total Volsubstance [t/a] = "Vol substance [t/a] per article
Example 9

Registration of same substance in several articles

Example: The same solvent is used in textiles and erasers
Total Vol substance t/a]= "Vol substance [t/a] per article= Vol substance [t/a] textile + Vol substance [t/a] eraser

The calculation of the total amount of a substance could be further improved by the use of specificconcentration of a substance. The total amount of substance contained in the article can be calculated if the produced or imported amount of the article is known:
Volsubstance [t/a] = (Conc. substance [%] # 0.01) # Volarticle [t/a]Example 10

Registration of substance intended to be released

Example: A T-shirt contains a fragrance substance intended to be released.
Assumption: The fragrance constitutes 5% by weight of the T-shirt produced within EU in an amount of 100 t/a
and it is not contained in other articles of the same producer.
Volfragrance [t/a]= (Concfragrance [%] # 0.01) # VolT-shirt [t/a] = (5 [%] # 0.01) # 100 [t/a] = 5t/a

Conclusion: The threshold of 1 t/y is exceeded; the producer of the T-shirt must register the fragrant for that use.

7.8

Registration of substances intended to be released from articles

For substances intended to be released from an article that has to be registered, the producer or importer of the article shall submit a registration to the Agency. The requirements for the registration
dossier are in general the same as for manufacturers and importers of substances. However, if achemical safety report is required (volume > 10 t/a) and the substance is classified as dangerous or
PBT/vPvB, the article producer must cover in his exposure assessment and risk characterisation
only the use of the article (i.e. article service life) and the disposal of the article.
The information to be submitted needs to be in accordance with Article 10 of REACH and depends
on the registered amount; i.e. the total quantity of the substance in all articles with intentional release (see Section 2.1). All available information as well as the standard information requirements
described in Annexes VII to X of REACH (taking into account the general adaptation rules of Annex XI and the criteria of Annex III) shall be collected and submitted for the registration.
Guidance on how to prepare a registration dossier is provided in the Guidance on registration. Assistance for participation in the SIEF and information collection can be obtained from the Guidance49

GUIDANCE FOR ARTICLES
on pre-registration, Guidance on data sharing and Guidance on information requirements andchemical safety assessment.

50

GUIDANCE FOR ARTICLES8CHECKING IF ARTICLE 33 AND ARTICLE 7(2) APPLY

The legal obligations of Article 33 and Article 7(2) are explained in Section 2.3 and 2.2 of thisguidance.

8.1

Obtaining information about substances of very high concern on the candidate list

Communication with suppliers is the best way for any article supplier to find out whether or not
substances of very high concern on the candidate list for authorisation are contained in the articles.
Communication can be targeted, as the identity of substances is available from the candidate list.
Furthermore, for many substances the article supplier can exclude their presence based on knowledge on the substance itself, as well as information on the article (see also Section 5.2). In communicating, the complexity of supply chains needs to be taken into account, as well as confidentiality
related to concentrations of substances in preparations and articles. Principles of supply chain communication and what information can be obtained from which actors are explained in Chapter 4.
Chemical analysis should only be applied as a last resort (see also Section 5.2).
In many cases substances of very high concern can be traced in the documentation of substancesand preparations used to produce the article. Producers of articles receive information on SVHC
from their EU suppliers of substances/preparations as the identity, the classification and the concentration ranges of SVHC in preparations have to be communicated either in safety data sheets or withinformation according to Article 32 (if contained in concentrations above the cut-off limits in
REACH article 14). In addition, safety data sheets of substances or preparations imported from nonEU Member States will often specify classified substances.
EU suppliers of articles containing SVHC in concentrations exceeding 0.1% (w/w) must deliver information available to them, sufficiently to enable safe use of the articles, as a minimum the nameof the substance according to Article 33(1) of REACH.
To identify communication obligations under Article 33 only the identity and concentration of an
SVHC on the candidate list need to be known.
To notify substances in articles according to Article 7(2), the total amount in the produced/imported
articles needs to be known in addition to the information required for article 33 communication, although exemptions apply if

8.2!

The SVHC has already been registered for that use(s)!

exposure of humans or the environment during normal and reasonable conditions of use including disposal can be excluded 24

Determining whether the article contains substances of very high concern

Article 7.2 and 33 do not apply if the concentration of a substance of very high concern on the candidate list is either not present or does not exceed 0.1 % (w/w) in his articles. In investigating thishe could use the strategies outlined in Section 5.2, including the likelihood of the presence or absence of certain substances in the articles or parts of the articles, as well as considering other legis24 See Section 2.8 in relation to documentation of such a conclusion.

51

GUIDANCE FOR ARTICLES
lation restricting or banning the use of certain substances in articles (see also a list of relevant legislation in Appendix 7).
Article suppliers should consider how to document their compliance checking (see Section 2.8) andcould include for example statements of their suppliers that substances of very high concern on thecandidate list for authorisation are not used, calculations proving that the concentrations in articles
remain equal to or under 0.1 % (w/w), safety data sheets of input materials, supply contracts anddocumentation of their implementation and auditing etc.
If the content of SVHC cannot be excluded, initially, it is only necessary to know whether or not thearticle contains a SVHC on the candidate list. The information may be obtained via: safety data
sheets, Article 32 information 25, supply chain requests etc. (see Chapter 4 and 5)
When no safety data sheet or other standardised information is available for the substances and/or
preparations in the article or the presence of an SVHC cannot be excluded, the following actions
could be performed:
Article producers! Request the supplier of substances/preparations included in the article to provide the registration
number, when available, the identity and concentration range of any SVHC on the candidate list
and contained therein. For article components, ask the supplier to either confirm that no SVHCs
on the candidate list are contained in concentrations > 0.1% (w/w) in the article or to specify theidentity and concentration of the SVHC in the article.
Article importers and only representatives! Request the supplier to confirm whether or not an article contains any SVHC on the candidate
list in concentrations > 0.1% (w/w). If the supplier cannot confirm this, ask for the identity andthe amount (or concentration) of these substances in the article. If he is not willing or able toprovide these, ask him to forward your request to the next actor up his supply chain or to provide you with the contact details of his suppliers.
All article suppliers! Collect information from studies and surveys, if available, on the specific article made by e.g.
EU Member States (e.g., www.mst.dk “Survey and migration of chemical agents in
toothbrushes”, Survey No. 42, 2004) and branch knowledge to confirm information from supply
chain communication or to find information on the likelihood of an SVHC being contained in
the article.
!

Check if the article conforms to any specific requirements such as standards, labels or other legislation that ensures that the content of some SVHCs is below a certain threshold level, e.g. the
TOXPROOF label/certificate of cars (Appendix 6).

If no or insufficient information to comply with articles 33 and 7(2) is made available by throughsupply chain communication and branch knowledge for a specific article as a last resort, a chemical
analysis may be conducted. For this, knowledge about which parts and materials of the article may
contain a SVHC is an advantage. For more information see Section 5.2.

25 Note that SDS and Art. 32 information can only confirm the presence of SVHC not exclude it.

52

GUIDANCE FOR ARTICLES

8.3

Workflow for checking whether forwarding information and notification are required

If SVHC(s) have been identified in the article, you may use the following workflow to check, if you
have to forward information in the supply chain and/or notify the Chemicals Agency. You may
start in the workflow at any point, depending on which information is available or easiest to obtain.
For example, it may be easier to calculate the total amount of an SVHC in the article than to check a
registration for that specific use.
The workload for notification is relatively low compared to that of registration and the amounts ofthe substance in the article only need to be known in tonnage ranges (for example 1, 10, 100 or1000). Avoiding a notification by excluding exposures (Article 7(3)) may require more effort thana notification itself. It is recommended to evaluate the costs before going into a more thorough assessment instead of just fulfilling a notification.
Determine if substances on the candidate
list are contained in the article(Section 8.2 of this guidance)
Candidate
substance contained?

No

Yes

Determine the concentration of substance in the article(Section 8.2 and 8.4 of this guidance)above
0.1 % w/w?

No communication or
notification required

No

Yes

Communicate information according to Art. 33(Section 8.9 of this guidance)

Check if substance is registered for that use(Chapter 9 of this guidance)

Registered?

No notification
requiredYes

No

Substance
intended to bereleased?

Yes

Chapter 7 ofthis guidanceNo

Determine total amount of the substance in all articles(Section 8.7 of this guidance)
Totalamount > 1t/a?
Notification
information(Section
8.10)

No notification
required

No

Yes
No

Can
exposure be excluded?

Yes

53

GUIDANCE FOR ARTICLESFigure 6

Checking the requirement to notify and to forward information on SVHC

w/w = weight per weight; Art = REACH Article, t/a = tonnes per year

8.4

Determination of the concentration of SVHC – focus on articles with different components 26

For each article, it must be determined whether the concentration of the identified SVHC is > 0.1%(w/w) in order to know what information has to be communicated down the supply chain. A further
assessment is needed to find out if a notification of these SVHC is required. Methods for obtaining
information on the concentrations of SVHC in articles and the use of quantitative chemical analysis
have been elaborated in previous chapters of this guidance (see Chapter 4, Section 5.2 and Section
8.2). However, it should be noted that an article producer should consider the possibility of usingmass balance for determining the concentration of SVHC in his articles and also be aware of thepossibility of accumulating a SVHC through a process. This chapter focuses on determining theconcentration of a SVHC in articles with different components.
The SVHC may be contained in different concentrations in different components of the same article, e.g. one concentration in the chassis of a computer and another concentration in the transformer. The concentration threshold of 0.1% (w/w) refers to the average concentration of the entire
article as produced or imported.
The principle to be applied when calculating the concentration of an SVHC in an article is illustrated by two cases:
1

Different components for a computer such as transformer, rectifier, mother board, memory,
processor, hard drive, graphics card, network card, sound card and chassis are purchased by a
producer of a computer. All these components are obtained from producers and importers
within the EU and the content of SVHC above 0.1% (w/w) should be indicated to the producer(Article 33) and possibly notified where needed by the suppliers of the components. The producer of the computer would therefore not have to notify any of those substances again.
Furthermore, if no components contain above 0.1% of a SVHC on the candidate list, also theentire computer would not contain above 0.1% and no further considerations are needed.
If one or more of the components contain more than 0.1% of a SVHC on the candidate list, theproducer of the computer would have to check whether the computer he places on the market
would contain above 0.1% of that SVHC – averaged over the weight of the computer. If yes, hewill have to supply information according to Article 33.
If the producer himself adds a SVHC to one or more parts of the computer, he will have tocheck whether the 0.1% threshold is exceeded for the computer he finally places on the market.
If yes, he will have to provide information according to Article 33. He may additionally have to
notify if the 1 tonne tonnage trigger for that SVHC is exceeded.

2

A chair is imported from Taiwan. It consists of a wooden part and a plastic part. The producerof the chair informs that the two parts contain xyz% and abc%, respectively of a SVHC on the

26 Dissenting views (http://reach.jrc.it/docs/guidance_document/dissenting_en.pdf), questioning the application of the

0.1 % threshold to the entire article have been notified by 6 Member States in writing (Austria, Belgium, Denmark,France, Germany and Sweden) and publication of this part of the guidance document was not endorsed by these Member States.

54

GUIDANCE FOR ARTICLES
candidate list. Based on this information, it is obligatory to check if the threshold of 0.1 % isexceeded. This could be done by calculating the concentration of this SVHC in the whole chairas described below and illustrated in the below example box.
The average concentration of a SVHC in an article is calculated as follows:
Conc. of SVHC $%% &Example 11

Amount of SVHC $g %#100
Weight of the whole article $g %Calculation of a concentration

Example of calculating a concentration:
A chair consists of a wooden part and a plastic detail. The weight of the chair is 2.001 kg.
The wooden part of a chair contains 10 mg of a SVHC. The weight of the wooden part is 2 kg.
A plastic detail of the chair contains 1 mg of the same SVHC and the weight of the plastic detail is 1 g.
The SVHC concentration in the chair:(10 # 10 (3 ' 1 # 10 (3 )g # 100% & 0.0005% (w/w) , which is < 0.1%.
(2001)g

Conclusion: The producer/importer has neither to communicate information down the supply chain according toArt. 33 nor to notify according to Article 7(2).

If the exact concentration in the article or the article parts is not known, a first screening may be
performed on the basis of the maximum amount or concentration in the whole article or the different parts. If this shows a concentration > 0.1%, a more precise determination of the SVHC amountor concentration should be made.

8.5

Check for an intended release of the SVHC 27

If the SVHC is intended to be released, registration may apply (See chapter 7). As previously described, notification is not needed if a registration according to Article 7(1) is required. The obligation to forward information to customers may however still be applicable if the concentration of thesubstance in the entire article is greater than 0.1 % (w/w).

8.6

Check for an existing registration for that specific use

According to Article 7(6) of REACH, substances in articles already registered for that use do notneed to be notified. See further guidance in Chapter 9.

27 Dissenting views (http://reach.jrc.it/docs/guidance_document/dissenting_en.pdf), questioning the application of the

0.1 % threshold to the entire article have been notified by 6 Member States in writing (Austria, Belgium, Denmark,France, Germany and Sweden) and publication of this part of the guidance document was not endorsed by these Member States.

55

GUIDANCE FOR ARTICLES

Determine the total amount of substances on the candidate list in all articles28

8.7

It is possible that the concentration of a substance on the candidate list is greater than 0.1% (w/w) inseveral different articles, e.g. a bag and a belt. To find out if a notification is required, the total
amount of the substance in all of these articles must be determined and summed up.
Calculate the total amount of the SVHC (g) in each article produced or imported per year with aconcentration of the SVHC > 0.1% (w/w):
The amount in one article is:
Vol SVHC $g / a % & (max . conc. of SVHC in article $%% # 0.01) # ( weight of article $g % # 10 (6 ) # (number of article/a)

The total volume is:
Total VolSVHC [t/a] = "Vol SVHC [t/a] of each type of article
Example 12

Calculation of the total amount of a SVHC used in production or imported

Example of calculation of the amount of a SVHC:
A company imports 20000 pairs of shoes, 3000 belts, and 60000 bags per year to the EU market. A pair of shoes
contains 0.05% (w/w) of a SVHC, a belt contains 0.15% (w/w), and a bag contains 2% (w/w) of the same
SVHC. The weights of the articles are 0.7 kg per pair of shoes, 700 g per belt and 1 kg per bag.
Concentration in belt and bag > 0.1% (w/w) ) calculate the total volume of the SVHC for each of the articles.
The total volume of the SVHC imported by the articles:!

Belts: VolSVHC [t/a] = (0.15% # 0.01) # (700 [g] # 10-6) # 3000 = 0.0032 t/a!

Bags: VolSVHC [t/a] = (2% # 0.01) # (1000 [g] # 10-6) # 60000 = 1.2 t/a

Sum up the total volume for all sorts of articles with a concentration of the SVHC > 0.1%:*VolSVHC = (0.0032 + 1.2) t/a = 1.2032 t/a, which is > 1 t/aConclusion: The company has to submit a notification for the SVHC in the bag and the belt. Furthermore, thecompany has to provide information for both the belt and the bag according to Article 33 of REACH.

8.8

Can exposure be excluded during normal or reasonably foreseeable conditions of use

Notification is not required if the producer or importer can exclude exposure to humans or the environment during normal or reasonably foreseeable conditions of use including disposal (Article 7(3).
Exposure to human or the environment can be excluded in the following situations:!

There is no release of the substance of concern during normal and reasonably foreseeable conditions of use(s) or disposal (see explanation of these terms in Appendix 1).

28 Dissenting views (http://reach.jrc.it/docs/guidance_document/dissenting_en.pdf), questioning the application of the

0.1 % threshold to the entire article have been notified by 6 Member States in writing (Austria, Belgium, Denmark,France, Germany and Sweden) and publication of this part of the guidance document was not endorsed by these Member States.

56

GUIDANCE FOR ARTICLES!

There is a release but the article is embedded during use(s) and the substance will not escape tothe environment or get into contact with humans during use or disposal. This could be the casee.g. for electronic parts inside of machinery.

This means that a producer/importer wanting to demonstrate ‘exclusion of exposure’ has to ensurethat the substance of very high concern on the candidate list does not come in contact with the usersof the article or with the environment, regardless of its dangerous properties. Note that all exposure
routes at all life-cycle stages (service life of the article and disposal) have to be considered. Waysof showing that no exposure occurs include arguments based on!

knowledge of the article and its service life, e.g. the SVHC is fully contained in the article,
and the article is collected and disposed of in a manner that prevents any release to the environment and exposure to humans under normal and reasonably foreseeable conditions!

knowledge of the substances properties, e.g. the substance is fully immobile in the article
due to the way it is integrated and because of its inherent physicochemical properties!

quantification based on exposure models, demonstrating no exposure during service lifeand disposal!

measurements proving that no emissions from the article take place including during its
disposalNote, that it may be more difficult to demonstrate ‘no exposure’ than making a notification. Somebasic principles are described below, for further guidance on how demonstrating that no exposure
occurs see the Guidance on information requirements and chemical safety assessment (exposure
based waiving).

8.8.1

Use and function of the substance and the article

The assessment of a possible exposure cannot be separated from the function (if any) or the use of
the substance in the article 29 and the use conditions of the article. The article producer or importer
needs to consider all normal and reasonably foreseeable conditions of use including disposal of thearticle and assess whether exposures can be excluded or not. It is recommended to document theconsiderations made on the normal and reasonably foreseeable conditions of use if the conclusion isthat exposure can be excluded.

8.8.2

Potential for release

The potential for release of a substance from a material in an article will depend on:!

The substancePhysicochemical parameters like vapour pressure and water solubility, stability in contact withair, water etc. and how the substance is combined into or onto the material.

!

The material the article is made of

29 A brief description of the use(s) of the substance in the article has to be included when notifying (Art. 7(4e)).

57

GUIDANCE FOR ARTICLESStructure and chemistry of the article matrix including physicochemical parameters and the way
in which the substance is incorporated in it (chemically bonded or not)!

The uses and disposal of the article!

Location of use (indoor or outdoor use, private homes, workplace etc.)!

Physical conditions at place of use (temperature, ventilation etc.)!

Whether or not articles are part of a comprehensive waste collection scheme!

The disposal technology

Some chemical substances are very firmly bound in the material, e.g. chromium in stainless steel,and the potential emission of chromium is therefore very low. Other substances are loosely incorporated in a matrix, e.g. softening additives in PVC. Such substances, like phthalates, are continuously emitted from the surface of the article. An alternative way, in which substances may be released, is through normal wear and tear of articles (abrasion). In this case, the substances are released together with the article matrix, e.g. additives in car tyres or outside surface coatings of the
car underbody.
A potential for emission may already have been identified if a material containing the specific
SVHC has been used before REACH enters into force. Check in the supply chain, branch organisations and available data sources (see examples in Appendix 6).

8.8.3

Exposure to humans and the environment

The next step is to assess whether exposure to humans or the environment can be excluded. The
whole life cycle of the article must be considered.
A: User groups

Consider the user group (industrial users, professional users, waste operators, consumers etc.). An
industrial process may be performed in a closed system. Note that waste processing operations may
give rise to considerable exposure of workers. For articles used close to the body, like clothes, shoesor jewels, the exposure to humans is obvious and cannot be excluded.
B: Environment

Exposure to the air, soil and water must be considered for the use phase as well as the disposal operations (cf. Guideline for exposure assessment in Guidance on preparing the Chemical Safety Report).
Can exposure be excluded?
!

If yes + supply appropriate instructions (cf. Section 8.9)!

If no + notification is necessary (cf. Section 8.10)

8.9

Forwarding information according to Article 33

According to Article 33(1), any supplier of an article containing SVHC on the candidate list in concentrations exceeding 0.1 % w/w shall supply the recipients with sufficient information, available to58

GUIDANCE FOR ARTICLES
the supplier, to allow safe use of the article. As a minimum the name of the SVHC shall be provided. Article 33(2) requires the same type of information to be forwarded to consumers upon theirrequest.
In any case, providing the name of the SVHC contained in the article is obligatory. In addition to
the name, it is obligatory to provide any information necessary to ensure safe use. This means thatobligatory additional information depends on what a user needs to know to ensure safe use. In orderto determine what information shall be provided to the recipient or to the consumer on request, thearticle supplier has to consider how the article is used, which exposures and risks could arise andwhich information, in particular on risk management, is required for the user of the article to ensure
safe handling.
Assessing and communicating on safe use under REACH in general means addressing the life-cycleof a substance from the stage of the respective actor. Article suppliers should consider the service
life of the article and appropriate instructions for its disposal. Specific storage or transport conditions should also be considered, where relevant for safe use of the article.
The information necessary to ensure safe use of the article could be communicated in different ways
and formats. The communicator should consider what type of information and level of detail is appropriate to the respective addressee, considering the conditions of their use and the level of knowledge. Information for the same article may thus be different regarding information type and detail(a professional user would e.g. normally not be informed that an article should be kept out of reachof children) and format (consumers may be informed with stickers, whereas professional user would
rather be provided with use instructions).
Whatever technique being used, ready access to the information should be guaranteed to any user 30.
Examples of information which could be provided to consumers!

An article is supplied with a risk of human exposure if sucked by small children and/or forenvironmental exposure if discarded as household waste:“Contains substance X that is (very) dangerous to health and/or the environment. Keep outof reach of small children. Handle waste as hazardous waste.”

An item of clothing is supplied with a risk of dermal exposure if in contact with skin:“Contains substance Y which is (very) dangerous to health. Do not wear in direct contact
with skin.”
Examples of what information could be provided to professional users!

!

Metal article e.g. a sheet that would normally be grinded during use and dust containing
the SVHC may be inhaled:“Avoid inhalation of dust from grinding by using effective point ventilation systems andwhere necessary also appropriate personal protection.”!

Plastic sheets from which the SVHC may leak to the environment if exposed to rain:“To avoid leakage to the environment do not use the sheets outdoors.”!

Brake lining from which a large fraction will wear during normal use and expose the environment to the SVHC:“Will lead to exposure to the environment during outdoor use. Indoors: Only professional

30 As the candidate list is subject to change, a link to a website with up-to-date information could be provided in addi-

tion to a paper label. However, a link would not be sufficient since the information is then not readily available.

59

GUIDANCE FOR ARTICLESuse.”
The following checklist could be used to decide what information may be required to forward toprofessional users.
!
!
!
!
!

Exposure controls/Personal protection
Handling and storage
Disposal consideration
Fire-fighting measures
Transport information

The information could be included in already existing documents, such as instructions for use andpackaging. Labels might be used in some cases. In addition, other techniques could be developed.
REACH does not specify a format for providing information with articles. You must choose a format that will ensure that the recipient can readily become aware of the information. Potential information items for inclusion are shown in Table 4.
Table 4 Information types for communicating on SVHC in article - Example
Item

ExampleSubstance name

Diarsenic trioxide

CAS Number

1327-53-3

Registration number(if provided by supplier)01-1234567-49-00

Classification and SVHC properties

Carc. Cat. 1; R45; May cause cancer
T+; R28; Very toxic is swallowed
C; R34; Causes burns
N; R50/53; Very toxic to aquatic organisms, may cause longterm adverse effects in the aquatic environment.

Concentration in the article 31

1% w/wInformation on safe handling including safe disposal if relevant

Prevent from heating above 60 °C
Keep article out of reach of children
This article should be disposed of as hazardous waste. Do notdispose of via normal household waste

8.10

Notification of a substance in articles

The information to be notified according to Article 7(2) shall include the following items:!

The identity and contact details of the producer or importer of the article!

The registration number(s) for the substance(s), if available!

The identity of the substance(s) (cf. Annex VI of REACH). This information will be available
on the candidate list

31 Concentration ranges could be considered in order to preserve confidential business information

60

GUIDANCE FOR ARTICLES!

The classification of the substance(s), which will be available from the Agency!

A brief description of the use(s) of the substance(s) in the article as specified in section 3.5 ofAnnex VI and of the uses of the article(s) (cf. Section 8.8.1)!

The tonnage range of the substance contained in the articles, i.e. 1-10 tonnes, 10-100 tonnes etc.
This information can be estimated as explained in Section 8.7.

61

GUIDANCE FOR ARTICLES9CHECKING WHETHER A SUBSTANCE IN AN ARTICLE HAS BEEN REGISTERED FOR THAT USE

A registration or notification of a substance in an article is not required, if the substance has alreadybeen registered for that use (REACH Article 7(6)).
This refers to any registration of that use of the substance up the same supply chain or any othersupply chain. It needs to be ensured that it is the same substance that has been registered. Comparing names, and EINECS or CAS numbers may not always be sufficient to establish whether substances are to be considered 'the same'. 32
Registrants have to provide a brief general description of the identified use(s) in the registration
dossier according to Annex VI Section 3.5. This part of the REACH requirements have been implemented in IUCLID 5 registration software to also cover whether a substance has been registered
for that use in relation to the article requirements via a standardised use descriptor system.
This standardised system has also been developed to facilitate the communication and descriptionof uses (see Guidance on the Chemical Safety Report). The system consists of four elements, specifying the industry sector, the preparation types, the processes and the article categories a substancecould be used in. It also specifies whether the substance is foreseen to be intentionally released or
not from an article. If the elements of the use description in a registration fit to the article containing
the substance, then this use can be regarded as a registered use. The use descriptors have been implemented in the IUCLID 5 software as standardised pick-lists (with options for the registrant tomake more specific or further entries if needed). Please refer to the Guidance on preparing theChemical Safety Report and the IUCLID 5 guidance for further information about the pick-lists andthe context in which the lists are to be applied.
Consequently, a potential registrant or notifier of a substance in articles checking whether a substance has been registered ‘for that use’ has to check by which process the substance has been included in the article, and into which type of article the substance has been incorporated in line withthe use descriptor system. Otherwise the substance is not considered registered for that use.
Information on non-dangerous substances and their registered use(s) will not normally be communicated along the supply chain, whereas for dangerous substances this should be communicatedwith the (extended) safety data sheet. However, the complete set of registered uses may not be identified in safety data sheets of preparations, as they are more specific, than those of the single substances.
Substances will be registered throughout the phase-in scheme until 2018. Thus, a substance may
not yet have been registered at the time a producer or importer of an article checks if his use has already been registered. More information on how to handle this is provided in Section 2.5 and Section 7.6 of this guidance.

32 Rules for the identification and naming of substances as well as criteria for substances being considered ‘the same’ or

not are provided in the Guidance on Substance Identification.

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GUIDANCE FOR ARTICLES

9.1

Information in the supply chain

If you need to find out which uses a substance has been registered for, the most likely option would
be to ask the suppliers in your supply chain, or to identify and ask a manufacturer or importer ofthat substance. They may either be aware of the registered uses from safety data sheets or other information or may have carried out a registration already and could tell you if they have registered
your use. They may also know other registrants who have registered that use. Registrants or future
registrants could also make a respective request in the Substance Information Exchange Forum(SIEF) (see also Section 2.5). Confidentiality of information may however be a problem for eitherside and exclude such communication.
You may start a request up the supply chain for registered uses of substances for which you haveidentified a possible registration or notification requirement. If you ask for a specific substance, thisrequest may be forwarded straight up to the manufacture of the substance. Usually, however, substances are used in preparations and the request may therefore need to be differentiated for the different substances contained therein. If you ask for ‘all substances in a preparation that you use’, ateach supply chain level, the request upstream may be forwarded to more actors as the different substances of a preparation may be supplied by various actors.

9.2

Information requests to the Agency 33

You may also be exempted if a Registration of your use of the substance has been made by an actor
in another supply chain.
Search for information on the Agency databases or make a request to the Agency to find out if a
specific use of a substance has been registered. For this step, it is a prerequisite that the identity ofthe substance is known (as a minimum, an identification number, such as CAS, EINECS, ELINCS
is required). On request, the Agency should be able to give a simple ‘yes’/’no’ answer to the question: “Do I have to register my substance in articles according to Article 7(1)?” based on the use
identifier given by the potential registrant.

In case the article producer/importer is still in doubt about whether his use has been registered, heshould consider further dialogue in this supply chain or within the Substance Information Exchange
Forum (SIEF).

33 This section may have to be revised, once the Agency working procedures on this issue have been established.

63

GUIDANCE FOR ARTICLES - APPENDICESLIST OF APPENDICESAPPENDIX 1: DEFINITIONS AND EXPLANATIONSAPPENDIX 2: BORDERLINE CASES OF SUBSTANCES/PREPARATIONS IN SPECIALCONTAINERS/ON SPECIAL CARRIER MATERIALS OR AS INTEGRAL PARTS OF
ARTICLES
APPENDIX 3: EXAMPLES ON DECIDING THE BORDERLINE IN THE SEQUENCE OF
PROCESSING NATURAL OR SYNTHETIC MATERIALS INTO FINAL ARTICLES, IN
PARTICULAR DECIDING ON 'SEMI-FINISHED PRODUCTS'
APPENDIX 4: ILLUSTRATIVE CASES FOR CHECKING IF REQUIREMENTS UNDERARTICLE 7 AND ARTICLE 33 MAY APPLYAPPENDIX 5: INFORMATION SOURCES ON SUBSTANCES IN ARTICLESAPPENDIX 6: INFORMATION SOURCES ON RESTRICTIONS AND METHODS FOR
DETERMINATION OF SUBSTANCES RELEASED FROM ARTICLESAPPENDIX 7: LEGISLATION RESTRICTING THE USE OF SUBSTANCES IN ARTICLES

65

GUIDANCE FOR ARTICLESAPPENDIX 1: DEFINITIONS AND EXPLANATIONSDefinition: Article according to Article 3(3)“Article means an object which during production is given a special shape, surface or design which
determines its function to a greater degree than does its chemical composition”.
Explanation

The main guidance contains comprehensive explanation about how the article definition is to be interpreted (see Chapter 3). In the following, the main principles are summarised:
1. In determining whether or not an object is an article or not, it is decisive that the shape, surface
or design are more important for an article’s function than its chemical composition.
2. It is important to determine the main function of an object (what its main purpose is) and to
identify the relevance of physical and chemical characteristics for achieving that function.
3. The function of an object should be determined consistently for a whole category of similar objects. It should be determined by the manufacturer's/supplier's intention (as evidenced e.g. on
the label texts, advertisements etc.), and/or by the expectations of the person acquiring it.
4. If an object merely acts as a container/carrier material to deliver a substance/preparation (suchas a spray can with a preparation in it, a printer cartridge, a pen, a cleaning tissue containing
chemicals, ink in a printed ribbon or on carbon paper etc.) then it is a substance/preparation in acontainer and not an article.
5. The article definition applies to an article ‘as produced or imported’. An article may be directly
used but may also be assembled into a complex article consisting of several articles (e.g. a computer or a car) 34.
6. The transition point of raw materials from substances/preparations to articles during processing
is to be determined also by comparing the importance of physical and chemical characteristics
for achieving the object’s function. Indicative questions are part of the guidance and examples
are provided in Appendix 3
7. Substances may be intended to be released from articles in order to provide an accessory function to the main function (e.g. fragrances in clothes).
Where the borderline should be set between substance/preparation and article may vary dependingof either the function of the ‘article’ or the type of material. Examples of different families of ‘articles’ and how to treat borderline cases between ‘article’ and ‘substance/preparation in a container’are presented in Appendix 2, while examples of the transition from ‘substance/preparation’ to ‘article’ are shown in Appendix 3.

34 Dissenting views (http://reach.jrc.it/docs/guidance_document/dissenting_en.pdf), questioning the application of the

0.1 % threshold to the entire article have been notified by 6 Member States in writing (Austria, Belgium, Denmark,France, Germany and Sweden) and publication of this part of the guidance document was not endorsed by these Member States.

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GUIDANCE FOR ARTICLES - APPENDICES
Definition: Use (Article 3(12))“Use: means any processing, formulation, consumption, storage, keeping, treatment, filling into
containers, transfer from one container to another, mixing, production of an article or any otherutilisation”.
Definition: Identified use according to Article 3(25)“Identified use means a use of a substance on its own or in a preparation, or a use of a preparationthat is intended by an actor in the supply chain, including his own use, or that is made know to him
in writing by an immediate downstream user.”
Explanation'Identified uses' are uses which are intended by an actor in the supply chain. This may include his
own uses, and uses made known to him in writing with the aim of making the use an identified use.

Registered for that use
Explanation

See Chapter 9 and details of the use descriptor system in Guidance on information requirements andchemical safety assessment, part D.

Intended release
Explanation

The requirements in Article 7(1) relate to substances (as such or in preparations) that are intended tobe released under normal or reasonably foreseeable conditions during the service life of the articles.
Both conditions, intended release and normal or reasonably foreseeable conditions of use, must be
met before registration requirements under Article 7(1) can be triggered.
As a general rule, the intention of the article producer in relation to the release of the substance isrelevant. The question “Is it wanted that a substance/preparation is released from the article during
its normal and reasonably foreseeable use because this is necessary for it to fulfil a certain functionof the article?” should be answered with yes. Intended releases are deliberately planned and have a
specific function for the article, which is frequently not the main but an accessory function of theobject 35.
A release of substances from articles is intended 36 when:

35 In cases where an intended release of substances is the main function of an object, it is to be regarded as a container

with substances / preparations inside but not an article. See also Chapter 3 of the guidance and Appendix 2 for further
information on the borderline between substances / preparations in special containers / carrier materials and as integral
parts of articles.
36 The list is not comprehensive, further situations where releases are intended / not intended are possible

67GUIDANCE FOR ARTICLES!

The release contributes to a (accessory) function of the article, or, in other words the, release
contributes to the ‘added value’ of the article, which is not directly connected to the end use
function. If the release would not happen, that function could not be fulfilled.
Example: Intended release in this sense is: Release of perfume from a perfumed eraser (function= to erase, added value / function for convenience = quality to smell good).

A release is not considered to be an intended36 release in the following cases:!

A release occurs during removal of 'impurities' from a semi-finished or finished article during
its production process (before marketing as a finished article).
Example: A size is added to a fabric to improve its process ability. Sizes are released during
further wet processing of the textile!

A release occurs during use or maintenance of the article and is meant to improve the productquality in a wide sense or the safety as a side effect but the released substances do not contributeto the function of the article.
Example: Washing of clothes by the consumer where remnants of different chemicals (dye, softener, starch etc.) from processing are removed over some washing cycles!

A release of substances is an unavoidable side-effect of the functioning of the article. Without
the release, the article would not work, but the release is not directly intended.
Examples: wear and tear of materials under conditions with high friction, e.g. break linings,
tyres

!

A release of substances formed during chemical reactions of any kind
Examples: Releases that are unavoidable for achieving the function, like ozone released fromcopy machines; release of substances from chemicals reactions caused by accidents or productmalfunction, such as combustion products from articles catching fire!

A release is incidental, could be forced by undue use or in an accident 37
Examples: release of substances from a thermometer which drops and breaks. This also includes any form of misuse and inappropriate use which is not in accordance with the use instructions or functionality, even if it could have been anticipated: A release caused by a longterm, extremely intensive use of e.g. a tool by a consumer, who uses it in disregard of the recommendations in respect of operating time provided in the instructions of use)

Definition: Manufacturer (Article 3(7)), Producer of an article (Article 3(4)) or Importer (Article
3 (11)“Manufacturer means any natural or legal person established within the Community who manufactures a substance within the European Community.”“Producer of an article: means any natural or legal person who makes or assembles an article
within the Community”
37 Although incidents could be foreseen under the conditions of use of the articles, releases caused by these are not in-tended. See also the explanation of intended release above.

68

GUIDANCE FOR ARTICLES - APPENDICES“Importer means any natural or legal person established within the Community who is responsiblefor import.”
Explanation

Note that the term “manufacturer” is used in REACH and the guidance documents in relation to the
manufacture of a substance (as such or in a preparation). The main obligation of a manufacturer
relate to the registration of substances. Importer may relate to importer of a substance (on its own orin a preparation) or an importer of an article.
The article producer/importer is responsible for fulfilling the requirements of Article 7 and 33 andcan be any company established within the Community who is legally responsible for placing thearticle on the market in the EU. Article producers are actors who manufacture articles in the EU
and article importers are actors importing articles manufactured outside the EU into the European
market (EU). The article producer can be an importer of articles at the same time and also haveother roles under REACH.
NB! Chapter 1 of the guidance explains that non-EU actors can appoint an Only Representative tofulfil the obligations of the importers.

Definition: Supplier of an article (Article 3(33))“Supplier of an article: means any producer or importer of an article, distributor or other actor in the
supply chain placing an article on the market”
Explanation

Actors supplying articles on the market may need to forward information on the content of SVHCs
on the candidate list. Any actor who places an article on the EU market, including retailers andowners of small shops are thus included in the information chain of articles. Only representatives
can also be suppliers of articles.

Normal conditions of use
Explanation

Normal conditions of use means the conditions associated with the intended function of an article.
They are frequently documented in form of user manuals or instructions for use. Normal conditionsof use for articles used by industrial or professional users may differ significantly from conditions
that are “normal” for consumers. This may particularly be true for the frequency and duration of
normal use as well as temperature, air exchange rates or conditions related to water contact.
Article producers or importers can give recommendations to avoid or exclude specific conditions
during normal use. It is explicitly not a “normal condition of use” if the user of an article applies anarticle in a situation or manner that the supplier of the article has clearly recommended to avoid in
writing, e.g. in the instructions or on the label of the article.
Examples of the exclusion of specific conditions of use are care labels in textiles “do not wash
above 30°C” and warning statements such as “keep out of children's reach” or “do not expose tohigh temperatures”.

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GUIDANCE FOR ARTICLES
Reasonably foreseeable conditions of use
Explanation

Reasonably foreseeable conditions of use mean conditions of use that are not as originally intended
by the article producer or importer (normal use) but which can be anticipated as likely to occur because of the form, shape or function of that article38. The term is relevant in several contexts of
REACH, e.g. registration and safety assessment under Article 6, for assessing whether a release isintended (Article 7(1)) or whether exposure of humans or the environment to an SVHC can be excluded under Article 7(3). Thus, the following list gives examples of which condition are reasonably foreseeable conditions of use but don’t preclude whether a release under these circumstances areintended or not.
The following conditions are considered reasonably foreseeable:!

“Accidents” of high likelihood, e.g. breakage of fragile containers releasing the chemical content which is an integral part of the article. These are to be considered as worst-case situations.

!

Uses not in accordance with the function but which can be anticipated because function and appearance of the article also suggests other uses than the intended ones!

Extremely intensive use (e.g. ‘a consumer’ working with a tool 12 hours a day for three months
when building his own house)

Excluded from reasonably foreseeable conditions in situations of professional and industrial uses
are:!

Uses, which are clearly and noticeably excluded by the article producer or importer. These uses
are to be regarded as use deliberately against the intention!

Uses, which have been clearly advised to be avoided by means of product design or warninglabels 39!

Clear misuse

Children are a good example to illustrate how reasonably foreseeable conditions of use can be identified: It is commonly known that children do not always know the function of an article but use it
for any purpose they associate with it. Especially small children put anything into their mouth or, if
the object is too big, bite it or lick it. Therefore, when defining conditions of reasonable foreseeable
uses of an article, children’s access to the article should be assessed.
The assessment of reasonably foreseeable conditions of use for articles solely used by industrial or
professional users can mainly focus on evaluating the likelihood of breakage/accidents (see comment in Annex VII of REACH) as uses not foreseen by the article function can normally (but notalways) be excluded.

38 The term is occurring in the General Product Safety Directive and in the guidance to the General Product Safety Directive, it isstated: “What are “reasonably foreseeable conditions” must be judged in the individual case and will change with market developments where consumers increasingly use complex products, for example medical devices and machinery”

39 An assessment of appropriateness of the design of a product to exclude such misunderstandings should be part of the considerations

70

GUIDANCE FOR ARTICLES - APPENDICESThe assessment of reasonably foreseeable conditions of ‘use’ should be targeted only to those situations where an increased exposure or an exposure via different pathways (inhalation, dermal contact
or ingestion) as compared to the normal conditions of use occurs.

Definition: Recipient of an article (Article 3(35)“Recipient of an article: means an industrial or professional user, or a distributor, being suppliedwith an article but does not include consumers.”

Definition: Substance (Article 3(1)) and Preparation (Article 32())“Substance means a chemical element and its compounds in the natural state or obtained by any
manufacturing process, including any additive necessary to preserve its stability and any impurity
deriving from the process used, but excluding any solvent which may be separated without affecting
the stability of the substance or changing its composition”.
“Preparation means a mixture or solution composed of two or more substances”
Explanation

Substances or preparations are used in the manufacture of articles. Under REACH, substances andpreparations may be accompanied by a safety data sheet according to Article 31 (if dangerous) or by
information according to Article 32 (non-dangerous, if (a preparation contains a) substance which is
restricted, to be authorised or requires specific risk management measures although it is not classified as dangerous). These are important information sources to identify substances present in articles as well as registered uses of the substances.
How to define the identity of a substance and name it under REACH is described in the Guidanceon Substance Identification.

Definition substances of very high concern (SVHC)

The following substances are considered substances of very high concern:!

Substances meeting the criteria for classification in accordance with Directive 67/548/EEC:!

Carcinogenic category 1 or 2!

Mutagenic category 1 or 2!

Toxic for reproduction category 1 or 2!

Substances which are persistent, bioaccumulative and toxic (PBT) or very persistent and very
bioaccumulative (vPvB) in accordance with the criteria set out in Annex XIII of REACH!

Substances having endocrine disrupting properties or substances having persistent, bioaccumulative and toxic properties or very persistent and very bioaccumulative properties or any otherproperty giving rise to an equivalent level of concern to those substances listed above.

71

GUIDANCE FOR ARTICLESExplanation

Substances of very high concern (SVHC) are substances, which may cause serious damage to human health or the environment (see above). They may be selected for inclusion in Annex XIV of
REACH or the candidate list for inclusion on Annex XIV.

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GUIDANCE FOR ARTICLES - APPENDICESAPPENDIX 2: BORDERLINE CASES OF SUBSTANCES/PREPARATIONS IN SPECIALCONTAINERS/ON SPECIAL CARRIER MATERIALS OR AS INTEGRAL PARTS OF
ARTICLES

In order to find out under which REACH article substances are to be registered, the status of theobject and the relation to its content need to be clarified. The main text of the guidance provides aworkflow and explanation on how to distinguish between a) articles with substances/preparations
forming an integral part of the article and b) special containers or carrier materials which contain
substances/preparations.
It is to be decided by the article producer or importer whether or not the article definition applies.
The following examples, the conclusions of which are summarised in Table 5, illustrate how to apply the workflow and indicative questions in the main guidance and how to draw respective conclusions.
Table 5

Summary of borderline cases described

Item/object

REACH requirements
Registration according to
Article 6 40

Printer cartridge
Spray can with paint
Adhesive tape that delivers substances/preparations (e.g. "ski-tapes")

Registrationaccording toarticle 7.1 41

x (ink)x (paint)x (the substance/
preparationdelivered)(Cartridge )(Can)(Backing material)xxAdhesive tapes for fixing carpets
Car tyresx

Scented eraserx
x(Container)(Wipe carrier material)

Battery
thermometer
Firecracker with gunpowder
Wet cleaning wipes

Notification according to article
7(2) and communication according to article 33 42

x (gunpowder)x (cleaning liquid)

Panty hose with lotionx

40 Special container/carrier material containing substances preparations
41 Article with intended release
42 Article with substances/preparations as an integral part (no intended release)73

GUIDANCE FOR ARTICLES - APPENDICES
Table 6
Indicative questions for borderline cases (articles with chemicals as integral
parts or substances/preparations in containers)
Spray can with
paint

Printer cartridge

Firecracker

Thermometer with a liquid

Function

Bring paint onto asurface

Provide ink for
printing

Explode and makefireworks

Measure and indicate thetemperature

Question 4a: If thesubstance/preparation
were to be removed or
separated from theobject and used independently from it orchanged from the object to a similar type ofobject, would the substance/preparation stillbe capable in principle(though perhaps without convenience or
sophistication) of carrying out the intended
purpose of the substance/preparation?

One could still
make a painting
even if the paintwould be separated from thespray can.

If the toner was
removed and filled
into any other typeof printing or writing device, it could
still execute its
function.

If the chemicals
were removed,
they could still
explode and makelight effects.

If the liquid was removed it
could still expand and contract with changing temperatures. To use thisproperty for temperature
measurement, the shape ofobject constraining thevolume, e.g. within a capillary is necessary. The
chemical loses its function
without a container but
could be used in other objects.

Question 4b: Does theobject act as a container or carrier for
release or controlled
delivery of the substance / preparation or
its reaction products?

The spray can ismainly intended
to deliver the
preparation in acontrolled way (itcontrols speed
and type of its
release)

!YES
! YES

! YES

! ambiguous

The cartridge ismainly intended todeliver the toner ina controlled way (itprovides the fit to
the printer and controls the release).

The function is tobring the substances or theirreaction products
into the air, thus todeliver them.

It is not the function of theobject to deliver a substance or preparation

! YES

! YES

! NO

The spray can isnormally disposed of separately from thepaint

The toner is normally consumed
during use and the
cartridge is disposed of separately.

The liquid and the container are disposed of together.

! YES

! YES

The explosive substances react andare separated fromthe container during use. Any containers or container
parts remaining aredisposed of separately.

! YES
Question 4c: Is thesubstance / preparation
predominantly consumed during the usephase of the object oreliminated or in any
other way outside theobject at the end of
useful life, i.e. before
disposal?

! NO

! YES

Predominantly answering with YES indicates that the object is a substance/preparation in acontainer.

In the case of the spray can, the printer cartridge and the fire cracker, the criteria all unambiguously
apply. Thus, these objects are containers with substances/preparations that need to be registered according to Article 6 of REACH. As noted in the main guidance these examples should be applied to
guide decisions on similar borderline cases. As an example, writing materials would (in analogy
with the printer cartridge) be considered substances/preparations in a (more or less sophisticated)
container.

74

GUIDANCE FOR ARTICLES - APPENDICESFor the thermometer, it could be assumed that it is an article with chemicals as integral parts, but theadditional criteria should be applied to further clarify its status.
Additional indicative questions for borderline cases (articles with chemicals as
Table 7integral parts or substances/preparations in containers)
Thermometer with a liquid
Question 5a: If the substance/preparation were to be removed or separated from the object
or exchanged for a similar type of
substance/preparation, would theobject be unable to fulfil its intended
purpose?

The container loses its purpose without the liquid.
! YES

Question 5b: Is the main purpose of
the object other than to deliver thesubstance/preparation or its reaction
products?

Delivering a substance / preparation is not the main function of the object. The
thermometer contains the liquid and provides a shape to regulate its expansion, necessary to measure and to show the right temperature. It is not the purpose to deliver the liquid! YES

Question 5c: Is the object normallydiscarded with the substance/preparation at the end of useful life, i.e. at disposal?

The liquid and the container are disposed of together.
! YES

Predominantly answering with YES indicates that the object is an article with substance/preparation as integral parts.

These questions can all be answered with yes, thus the thermometer is an article with the liquid inside being an integral part of it.

75

GUIDANCE FOR ARTICLES - APPENDICES

Table 8 Indicative questions for borderline cases (articles with chemicals as integral parts or
substances/preparations on special carrier material)
Printer ribbon

Wet cleaning wipes

FunctionTransfer ink to paper

Cleaning (surfaces)

Question 4a: If the substance/preparation
were to be removed or separated from theobject and used independently from it orchanged from the object to a similar type ofobject, would the substance/preparation stillbe capable in principle (though perhaps without convenience or sophistication) of carryingout the intended purpose of the substance/preparation?

If the ink was removed
and filled into othermaterials / containers it
could still fulfill its
functionIf the cleaner was removed it could still
carry out its function ofcleaning.

! YES

! YES

Question 4b: Does the object act as a container or carrier for release or controlled delivery of the substance / preparation or its
reaction products?

The main function is todeliver the ink to thepaper.

The main function of
the object is to deliver
the cleaning agent 43.

! YES! ambiguous

When the ribbon is disposed, most of the ink
has been consumed.

The cleaning agents are
predominantly consumed 44 and the wipe
is disposed of separately.

Question 4c: Is the substance / preparation
predominantly consumed during the usephase of the object or eliminated or in any
other way outside the object at the end of useful life, i.e. before disposal?

! YES

! YES

Predominantly answering with YES indicates that the object is a substance/preparation in a
special carrier material.

For the printer ribbon, the answer to all questions is yes, thus it is a special carrier material with
substances/preparations. For the wet cleaning wipes, the answers may be ambiguous and then thesecond set of indicative questions should be applied.

43 It also has a second function in wiping the ‘dirt’ off.
44 This is regarded as true, although in reality a large part of the cleaning agent may not actually be consumed, as its

function is to be released as far as practical.

76

GUIDANCE FOR ARTICLES - APPENDICES

Table 9Additional indicative questions for borderline cases (articles with chemicals as
integral parts or substances/preparations in special carrier materials)
Wet cleaning wipes
Additional criteria

There is one ambiguous answer, ! additional
criteria are used to cross-check

Question 5a: If the substance/preparation were to
be removed or separated
from the object or exchanged for a similar typeof substance/preparation,
would the object be unable
to fulfil its intended purpose?

The dry wipe could also be used to clean however, the cleaning result would be less goodand not achievable for ‘specific dirt’, for which
the wipes are normally designed.
It is the preparation added to the tissue thatreally makes the difference between one wet
tissue (e.g. a glass/window cleaner) and another (e.g. a tissue to clean babies)! NO

Question 5b: Is the main
purpose of the object otherthan to deliver the substance/preparation or its
reaction products?

The main function of the object is to clean andin this to deliver a cleaning agent to the item to
be cleaned.

Question 5c: Is the object
normally discarded withthe substance/preparation
at the end of useful life,
i.e. at disposal?

It is the intention that the cleaning lotion isconsumed, although the disposed wipes stillcontain remnants of the substance.

! ambiguous! YES

Predominantly answering with YES indicates that the object is an article with substance/preparation as integral part.

The cleaning wipe is regarded as a special carrier material with the cleaning agent being a preparation which is to be registered under Article 6.

77

GUIDANCE FOR ARTICLES - APPENDICESADHESIVE TAPES

Adhesive tapes can have different functions. In principle the adhesive layer provides the function toadhere. The carrier material (backing or the internal reinforcement) gives the tape a specific surface
and design and provides the function of ‘keeping the adhering items together’ and/or to retain its
specific surface shape and design. Without the carrier material (backing or the internal reinforcement), there would be no ‘direction’ in the adhering material and the tape would not retain its shapeand design. Depending on the exact function and the way tapes work, three cases can be distinguished, which are assessed in the following table.

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GUIDANCE FOR ARTICLES - APPENDICES
Table 10

Applying indicative questions to pressure sensitive adhesive tapes
Adhesive tape that delivers substances / preparations onto a surface

Adhesive tapes that
do not deliver substances / preparations onto a surface

Adhesive tape that do
not deliver substances/ preparations onto asurface but release
substances

ExampleThermally activated tapeand bonding films, adhesive mastics in tape form(mechanically activated),
wax tapes for skis andtransfer tape without aninternal reinforcement.

Tapes with adhesive
layers on one or bothsides of a backing
material (e.g. forfixing carpets) andtransfer tapes withinternal reinforcement.

Children’s tape withfruit odour, decorative
tape with insecticides.

Type of object

Special carrier material
containing substances /preparations. The carriermaterial serves only as
release liner and aid toeasy application. The
adhesive layer may
change its shape upon
application.

Article with adhesive layer and with abacking or internal
reinforcement as anintegral part

Adhesive tape withadhesive layer as integral part and release of
substances / preparations as secondaryfunction

Question 4a: If the substance/preparation
were to be removed or separated from theobject and used independently from it orchanged from the object to a similar typeof object, would the substance/preparation still be capable inprinciple (though perhaps without convenience or sophistication) of carryingout the intended purpose of the substance/preparation?

The adhesive layer iscapable of carrying out
its intended purpose(which is not necessarily
mainly to adhere!),though with less convenience.

The function of the tape is determined by theinteraction between the backing or reinforcement and the adhesive. The adhesive layer
without the backing material or the reinforcement is not capable of carrying out the intended purpose of the tape.

Question 4b: Does the object act as a container or carrier for release or controlled
delivery of the substance / preparation or
its reaction products?

The tape’s function isthe controlled delivery ofa substance or preparation

The tape’s function is not to simply control therelease or delivery of the adhesive layer but toadhere to the substrate and to provide additional qualities through the backing or internal
reinforcement.

Question 4c: Is the substance / preparation predominantly consumed during theuse phase of the object or eliminated or in
any other way outside the object at theend of useful life, i.e. before disposal?

The adhering layer andthe carrier material aredisposed of separately atthe end of their respective useful lives

The adhesive remains on the tape at the end ofits useful life

Consequences regarding Article 7(1)Substances in the adhesive layer may need to beregistered under Article
6.

No registration requirement

The fragrances mayneed to be registeredunder Article 7(1)Terms used in the table are defined according to EN 12481:
Backing: Flexible material like for example fabric, foil or paper which can be coated with a pressure sensitive adhesive.
Double coated or double sided tape: Backing which is coated on both sides with pressure sensitive adhesive.
Reinforcement: a material which strengthens the backing and/or the adhesive.
Release liner: a removable material which protects the adhesive face or faces.
Substrate: a surface or material to which the tape is applied.
Transfer tape: an adhesive tape having two pressure sensitive surfaces without the need of a carrier and with a release liner separating
the adhesive surfaces. The adhesive layer can contain reinforcing materials.

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GUIDANCE FOR ARTICLES - APPENDICESBATTERIESThe main function of batteries is to provide electric current.
The voltage is produced through a chemical reaction (of) between two unlike materials, occurring
simultaneously at two different electrodes (such as the positive and negative plates), which are immersed in an electrolyte (liquid or solid). Without the chemical reaction, no voltage would be produced. Hence the chemical composition is very important for the function.
The external and internal shapes and designs of the battery ensure that the reaction takes place in acontrolled way and that the energy is provided continuously, at the time needed and in a useable
form. Thus, also the shape and design of the battery are important for the function.
1) The electrolyte and the electrode active materials as such cannot provide any electric current outside the battery. Filled into other containers without the specific design of a battery, they would
also fail to provide energy. The ‘container part’ of the battery, emptied of the electrolyte, is also notable to fulfill its function. However, there are different types of electrolytes which could be used in
one battery casing.
2) The electrolyte and the electrode active materials are not released from the battery, thus the container does not have a function of ‘delivering’ it and does not control its release3) The electrolyte, the electrode materials and the battery casing are normally discarded together.
As a consequence, the battery should be regarded as an article containing a preparation as an integral part. There are different types of batteries and some of them may not fulfill all criteria in thesame way. For example in car batteries the electrolyte may in certain cases be exchanged and bothelements are discarded separately. Also the shape and design can vary to a very large extent. However, the principle of functioning is the same and thus, all batteries should be treated in the sameway.

PANTY HOSE WITH A LOTION

In the case of the panty hose, the main function is to provide clothing. Therefore, the pantyhose as
such is clearly an article whose main function is unrelated to the lotion. The function of the lotion(skincare) is only accessory.
However, the lotion has an intended release, as the skincare function would not be achieved if thesubstance were not released.
As a consequence, the panty hose with a lotion should be regarded as an article with an intended
release.

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GUIDANCE FOR ARTICLES - APPENDICESAPPENDIX 3: EXAMPLES ON DECIDING THE BORDERLINE IN THE SEQUENCE OF
PROCESSING NATURAL OR SYNTHETIC MATERIALS INTO FINAL ARTICLES, IN
PARTICULAR DECIDING ON 'SEMI-FINISHED PRODUCTS'

The main guidance text (Chapter 3 and in particular Section 3.3.1) contains explanations and indicative questions to determine the transition point from a substance/preparation to an article for a raw
material during its processing. This appendix should be used in conjunction with that text. The appendix illustrates the application of the article definition to different types of raw materials. It exemplifies how the indicative questions could be answered and how they could assist in deciding
whether the material is to be considered an article.
It should be noted that the borderline between substance/preparation and article may be different forvery similar types of materials (e.g. there might not be the one solution for all types of fibres). Thus,
it should be avoided to draw conclusions on the status of the same type of a raw material in different sectors, as it may fulfil different functions.
Thus, whether or not a raw material is an article must be decided case-by-case. However, industry
sectors may develop further guidance based on Section 3.3.1 in the guidance and this Appendix.
In the following, guidance on where and how to set the borderline during the refinement of raw materials and production of various final articles is given for four sectors: metals, textile (in cooperation with non-woven industry), paper and plastic. The examples are intended to illustrate the decision making process and it should be stressed that if in doubt a careful examination in line with theoutlined criteria should always be conducted. In line with this, the following examples should beapplied with care as also indicated in the accompanying text.

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GUIDANCE FOR ARTICLES - APPENDICES

1METAL PROCESSING - SHOWN FOR ALUMINIUM PRODUCTS AS EXAMPLE

The example of aluminium processing is included to show the transition point in the processing of
bauxite to final aluminium products. It should be noted that the processing of other metals (for example iron/steel) may show different transition points. The following figure shows the different
processing stages and the respective status of the raw material.
Aluminium products
Natural raw
material

Mineral ore(bauxite)
extraction

substance

Alumina Al2O3
electrolysis

substance(metal)Aluminium
addition of alloying elements

preparations
Aluminium alloy
casting into shapes
casting into ingots

Rolling
ingotsExtrusion
ingotsRolling andfurther treatment

Extrusion

articlesSheet(coils)Cutting, forming,
coating

Final aluminium
product

Extrusion
profileCutting, forming,
coating

Final aluminium
product

Aluminium
alloy cast piece
grinding,
drilling,
surfacetreatment…

Final aluminium
product

Figure 7 Example of the general transition point from mineral to final aluminium article 45

The transition point from preparation to article is set between rolling ingots and sheets, extrusion
ingots and extrusion profiles and aluminium alloy and alloy cast pieces. The decision process as
supported by the indicative questions in the main guidance (See Section 3.3.1) could be as follows.

45 Note the exceptions as indicated in the text!

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GUIDANCE FOR ARTICLES - APPENDICES

Table 11 Inidcative criteria in aluminium raw material processing (coils, profiles)
Material
Question
Does the material in question have a function otherthan being further processed?

Rolling and Extrusion Ingots

Coil/extrusion profile

Final product, e.g.
coated sheet/final
product

No

Aluminium extrusion profiles can often be
directly used in construction works indicating that they should be considered articles.
Extrusion profiles not having an end-use
function should be considered preparations.

Yes

NB! Other metal alloy coils may need considerable further processing, which may
indicate that they should be considered
preparations rather than articles.

Does the seller put the material on the market and/or
is the customer mainly interested in acquiring a material because of its chemical composition or its
shape/surface/design?

Seller/buyer of rolling
ingot offers/acquires acertain chemical composition. The shape of
the ingot determines
the nature of next
processing step (rolling), but is not considered more important
than the chemicalcomposition.

After which processing stepis the function determined
to a larger degree by theshape/surface/design?

Before rolling / extruding, the ingots haveno specific form. After the rolling / extrusion they are significantly enlarged andhave a totally different shape, which iscreated deliberately during the process.

Does the chemical composition of the material as
such remain similar in thenext processing steps as achange may indicate thematerial being a preparation?

The chemical composition of the rolling
ingot is not changed
during the further
processing

If the buyer of a sheet is most interested inbuying a material with a specific shape andsurface (flat sheet) for the purpose of its
end use, then the material may be considered as an article. However, if the shapeand surface (flat sheet) is mainly purchased
for the convenience of transforming theshape, surface or design, then it is an indication that the material should be considered as a preparation.

The coated sheet
could be used forconstruction ofvehicles.
Modified extrusion
profiles could be
used in several applications such as
tubes or, whenanodised, as door
and window
frames.
The shape, surface
and design of thematerial is normally of more importance for thebuyer than thechemical composition. .

The processing of coils to sheets and of extruded profiles to doors and window framesconsists of e.g. cutting, forming, coating. The
materials have more or less the same shape
before and after the process (‘light processing').

The chemical composition of the sheet
could be changed during further processing(e.g. application of surface coating)

The overall chemical composition of
the object may
change in that substances may be
added to the sheet/
extrusion profile,wire.

Similar raw material type in the form of metal and alloy semi-finished products as coil and profile
are: bars, blanks (e.g. cut, machined, pressed, etc), coil (coated and uncoated), extrusion profiles,
films and filaments, foil and ribbons, forgings, plate, pipe and tube (cast, seamless and welded),pipe and tube fittings, sintered semi-finished and final products, sheet and strip (coated and uncoated), stampings, wire rod and wire (coated and uncoated).

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GUIDANCE FOR ARTICLES - APPENDICES
Conclusions on aluminium alloy rolling ingots/coils
Rolling ingots do not normally have an end-use function indicating that these would normally be
preparations. It is ambiguous and case-dependent whether a coil has an end-function in itself. In
any case a cutting or stamping process is required for achieving a definite function. As this would
generally be considered as light processing, this question indicates towards the coil being an article.
The interest of the buyer/seller in chemical composition versus shape/surface and design generally
changes between the ingot and the coil/profile. Although the composition plays a role with regard
to the quality of the material, the buyer would primarily look for the form of the objects. In the caseof the rolling ingots, the shape is considered important (determines the next processing step), but
normally not more important than the chemical composition. This is an indication that the ingot is apreparation, whereas the coil is normally an article.
Whereas the rolling ingots only determine into which type of processing the raw material is introduced next, the form of the coil already determines that only sheets can be produced from it. The
rolling process significantly changes the form of the ingots in many ways. The cutting / stamping
and further processing of the coil only results in modifications of that basic shape and can be regarded as light processing. ‘Limited processing’ in the sector covers for example cutting, drilling,
bending, piercing, surface treatment, coating, etc, but excludes processes such as melting, extrusion,
sintering, etc, where the formed shape is destroyed or significantly changed. This is an indicationthat the process, after which the status of the raw material is changed, is the rolling into sheets/coils.
The basic chemical composition of the material (aluminium alloy) is not changed during the entire
processing, although through coating or surface treatment (e.g. anodising) or lubrication (e.g. greasing, oiling, etc) substances / preparations may be added. This question is not a helpful indicator inthis example, as it does not give clear indications on the raw material’s status.

Conclusions on aluminium alloy extrusion ingots/profiles
Already the first question gives an unambiguous indication for the extrusion ingots having no enduse function and therefore indication for being preparations, whereas the extrusion profiles, which
can be used directly to fulfil a distinct function, have a clear indication for being articles.
The interest of the buyer/seller in chemical composition versus shape/surface and design generally
changes between the ingot and the profile. The shape of the extrusion ingots is irrelevant with regard to the extrusion profile, thus the buyer of the ingots would only be interested in the chemicalcomposition of the material. This is a clear indication that the ingots are preparations.
The extrusion process significantly changes the form of the ingots in many ways, whereas the processing steps carried out with the extrusion profiles only result in modifications of that basic shape.
This shows that the transition point of the material should be after the extrusion process.
The basic chemical composition of the material (aluminium alloy) is not changed during the entire
processing, although through coating or surface treatment (e.g. anodising) or lubrication (e.g. greasing, oiling, etc) substances / preparations may be added. Also in this case, the question is not helpful in determining the transition point.

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Table 12

Inidcative criteria in aluminium raw material processing (cast piece)

Material

Alloy ingots forremeltingAlloy cast piece

Final aluminium product

Does the material in question have a function otherthan being further processed?

No

Yes

Yes

Castings (alloy cast pieces)are produced close to the required finished design andshape and only require further
light processing.

Aluminium final products areused in the construction of vehicles, domestic appliances and,
when anodized, for architecturaland building applications.

Does the seller put the material on the market and/or
is the customer mainly interested in acquiring a material because of its chemical composition or its
shape/surface/design?

Seller/buyer of alloy
remelting ingots offers/ acquires a certain
chemical composition
rather than a certain
shape. The shape of
the ingot does not determine the nature ofnext processing steps(melting and casting).

The buyer of an alloy castpiece (casting) is interested in
it having already the basic
shape and design.

The shape, surface and design ofthe material is normally of more
importance for the buyer than thechemical composition.

After which processing stepis the function determined
to a larger degree by theshape/surface/design?

As the shape of alloy remelting ingots is
entirely lost during the melting process,they have no specific form. After casting, a
totally different shape is developed, whichis created deliberately during the process.

Does the chemical composition of the material as
such remain similar in thenext processing steps as achange may indicate thematerial being a preparation?

The chemical composition of the alloy
remelting ingot is notchanged during thefurther processing

Question

The chemical composition is(normally) of less importanceas compared with theshape/surface/design.

The processing of alloy cast pieces (castings)
to finished products consists of e.g. grinding,
drilling, surface treatment. The materials
have more or less the same shape before andafter the process (‘light processing').

The chemical compositionof the alloy cast piece(casting) could be changed
during further processing(e.g. anodizing)

The overall chemical compositionof the object may change in that
substances may be added to the alloy cast piece (casting).

Similar raw material types as the aluminium alloy cast piece: castings (e.g. centrifugal, die, investment, sand, etc), continuous cast shapes (e.g., bars, billets, blooms, rounds, slabs),
A case-by-case consideration should normally be done to make the final decision on a material’s
status.
The examples of the metal industry show that it is not always a straight forward decision whether or
not a raw material has a function that is determined by its shape, surface or design. This is particularly true, when an object could be used either for an end use or for further processing and where
the further processing is only modifying the shape.

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GUIDANCE FOR ARTICLES - APPENDICES2TEXTILE AND NON-WOVEN PROCESSING

NB! This example cannot be directly applied for all types of (man-made) fibres.

The figure shows the various processing steps and methods applied in the textile and non-woven
industry. Independent of the type of raw material (synthetic or natural material), the processing
stage ‘man-made textile and non-woven fibres’ is regarded as an article. Thus, any further processing is seen as processing of articles.

Monomers
Naturally occurring
resources

Substance(exempted)

Synthetic
polymers

Regenerated andnon-regenerated
natural polymers
e.g. cellulose pulp

Polymer substance(exempted)

Spinning / drawing
Man-made fibres

Tow

Filament yarn

Monofil
Spunlaid & meltblown
nonwoven forming
and bonding

Figure 8 Illustrative example of the general transition point from raw materials final textile/ non-woven articles 46

46 Note the exceptions as indicated in the text!

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GUIDANCE FOR ARTICLES - APPENDICES

Table 13
fibres)Inidcative criteria in textile/non-woven raw material processing (man-madeMaterial

Synthetic polymer

Man-made fibre

Tow rope

Does the material in question
have a function other thanbeing further processed?

No

Man-made fibres could for example beused as filling material for pillows or dental floss

Tow ropes havevarious functions

Does the seller put the material on the market and/or is thecustomer mainly interested inacquiring a material becauseof its chemical composition orits shape/surface/design?

The interest inpolymers is clearly
in its chemical nature and not in its
shape

The shape, surface and design of the material is normally more important for the
person acquiring a man-made fibre.

The shape of the
tow rope ismore important
for the buyer
than the chemical composition.

After which processing step isthe function determined to alarger degree by theshape/surface/design?

The polymer does not yet have a specific form.
By spinning / drawing fibres are produced
which have a shape and design (‘diameter’)which are deliberately formed during processing.

Does the chemical composition of the material as suchremain similar in the next
processing steps as a change
may indicate the material being a preparation?

The composition ischanged before extrusion (additives,crosssectionalization)

Question

Shape and design determine the end-use
function. In many applications synthetic
fibres can be substitutes for each other.

Before the processing the fibres
already have a specific form
which is further developed in thenext processing steps, such as
cutting, twisting, finishing. The
fibre itself exists in the same state
as before but has been ‘bundled’.

The chemical composition of the manmade fibre may be changed in order toenhance its processability, or throughdyeing. The basic composition of the fibre is however the same

The tow rope is
not further processed.

For the man-made fibre, for some applications the first question can be answered unambiguously, as
the man-made fibres already have a function other than being further processed whilst for other applications the main function is the further processing. Thus the fibre in principle can be an article
already. The same applies to the tow rope.
The buyer of a man-made fibre is normally most interested in acquiring a material with a specificshape, rather than a certain composition. The fact that fibres with different composition can substitute each other is another indication for the higher relevance of physical properties.
The buyer of a tow rope is undoubtedly most interested in the shape of the tow rope than in its
chemical composition.
The type of extrusion / drawing determines the diameter of the fibre and therefore it is the processing step that deliberately forms the shape of the fibre. Further properties like strength, elongationand shrink are given to the fibres in this step as well. The man-made fibres are ‘assembled’ in different processes to form the final products, like the tow rope. These processes are mainly mechanical and do not change the base structure of the fibre, but simply ‘aggregate’ it to larger units.
The basic chemical composition of the polymer may be changed after the extrusion / drawing
through various types of processing (depending on the type of further processing).
The example shows that the stage at which the function is determined by shape, surface and design
may be very early in the raw materials processing. Furthermore, the design is the relevant physicalproperty of the fibre, as its overall shape does not change significantly in the further processing.

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GUIDANCE FOR ARTICLES - APPENDICES3POLYMER PROCESSING

In the polymer processing industry, the transition point from preparation to article is defined after
the conversion of polymer pellets. The conversion process is what transforms the preparation into
an article. The figure shows one example product / process which can be regarded as typical for thepolymer processing industry and therefore represents also other processes like calendaring, injection
moulding, etc.

Plastic products
Natural raw
material

Crude oilRefinery

Substance(monomer)

Preparation(polymer)

Ethylenepolymerisation
incorporationof additives
PE pellets
Film blowing

articlePE foils
Cutting
gluing etc.

articlePE packaging

Figure 9 Illustrative example of the general transition point from raw materials to plastic
articles (PE foils)

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Table 14

Inidcative criteria in processing of polymers

Material

Polymer pellet

PE-foils

PE packaging

Does the material in question have a function other than being further processed?

No

Direct application as packaging possible, also without further processing.

Packaging

Does the seller put the material on themarket and/or is the customer mainly interested in acquiring a material because of
its chemical composition or its
shape/surface/design?

The converter selects
polymer pellets according to their chemicalcomposition. The shapeis not relevant.

The buyer of foils is most interested in its
shape. For many functions foils of different
chemical composition can be used.

After which processing step is the function determined to a larger degree by theshape/surface/design?

The conversion unit causes the deliberate formation of a shape of thepolymer material, which determines
its function.

Does the chemical composition of thematerial as such remain similar in the next
processing steps as a change may indicate
the material being a preparation?

Before extrusion, additives are mixed into theraw material to obtaincertain functionalities.

Question

Further processing doesn’tchange the design (except if thematerial is reused) but only
modifies it.

The chemical composition of the foil itself
does not change in the further processing
steps, but it could be printed onto.

Whereas the polymer pellets do not have an end use function yet, the converted materials are likely
to have one. In the example, the PE foil can directly be used for packaging and can also be used
and modified in further processing.
In the conversion unit, the structure and design of the polymer compounds is changed. In the resulting material the design and structure is kept in any further process (except if the material is reused).
Thus, for the polymer processing example, the criterion of an existence of an end use function coincides with the existence of a fixed design (micro and macro structure) of the material.
For the polymer sector, this means that processes including for example, but not limited to, pipe extrusion, film blowing, blow moulding, sheet forming, rotomoulding, foaming, compression moulding, fibre spinning or tape slitting calendaring, coating or injection moulding mark the ‘red line’ between preparation and article.

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GUIDANCE FOR ARTICLES - APPENDICES

4PAPER PROCESSING

The transition point from preparation to article is between the stock and the dried paper.
Integrated Paper Making

Chipping

Wood (natural
raw material)

Stockprepara-Pulping

Chips

Cellulose
Is a Substance(no registration)

Stock
Is a Preparation

Potential Input of substances / preparations

Convert-Final paper productIs an Article

Figure 1090Treatments

Post treated paper
is an Article

Paper
is an Article

Formation,
dewatering, drying

Illustrative example of the general transition point from wood to paper articles

GUIDANCE FOR ARTICLES - APPENDICES

Table 15

Indicative criteria in raw materials processing in paper manufacture

Material

Stock

Paper

Postcard

Does the material in question have a function
other than being further processed?

No

Yes, could be used assuch e.g. for packaging

Yes, nofurther
processing

Does the seller put the material on the market
and/or is the customer mainly interested in acquiring a material because of its chemical composition or its shape/surface/design?

Stock is mostly liquid
and thus does not havea shape, surface or design, yet

For the buyer the shape of the paper ismost relevant.

After which processing step is the function determined to a larger degree by theshape/surface/design?

After dewatering / drying thestock is given a specific shape,surface and design for the firsttime.

Does the chemical composition of the material
as such remain similar in the next processing
steps as a change may indicate the material
being a preparation?

Chemicals may be
added

Question

The further processing (here:
cutting, printing) does notchange the basic design. Although shape & surface aremodified, the properties ofthe ‘paper’ already determine
the function

Yes, surface treatment,
gluing etc. may add substances / preparations.

No further
processing

The paper as obtained from the paper machine could already have an end-use function, e.g. packaging of filling material. Although it is further processed to better fulfil a specific purpose, the paper
already has a function apart from being raw material for further processing.
The dewatered paper is the first stage of the raw material, which does have a specific shape, surface
and design. Any previous production stages of the raw material can therefore not represent an article status.
The further treatment of paper may change the overall shape of paper significantly however; thedesign is not changed.

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GUIDANCE FOR ARTICLES - APPENDICESAPPENDIX 4: ILLUSTRATIVE CASES FOR CHECKING IF REQUIREMENTS UNDERARTICLE 7 AND ARTICLE 33 MAY APPLY 47

Case study on intended release from articles - work processes under REACH Article 7(1)Scented children’s toys
Description of case

Scented children’s toys are chosen as an example of articles with intended release.
As no specific toy study was identified, a study on scented felt tip pen/markers was used to establish
some basic information (Danish EPA-unpublished 48). It is assumed that the results from that study
are representative for this toys case and the same process of data collection is assumed to have beentaken for children’s toys.
NB! It should be noted that in case a felt tip pen would have been considered, the release of ink (inanalogy with other writing/printing materials – see Appendix 2) would be considered a preparation
in a container, whereas the scent in such a pen would provide an accessory function and therefore
be a case for registration under Article 7(1).
The case is chosen to illustrate the difficulties that an importer of articles may face if he cannot get
any information on the substances contained in the imported article from his suppliers.
The following is assumed:!

Import per year: 1 million scented toys!

Weight of toy part containing the fragrance: 2 g!

No information on content of substances to be released!

No information on registration!

Results on the analysis from the survey report are assumed to be performed on the toys by theimporter

Substance identity
In order to identify the substances intended to be released, the importer of the scented toys could take theapproach as done in the Danish study on felt tip pens, the process of which is quoted here:
In the Danish study, in order to obtain information on the substances to be released from the pens the following analyses were done:

47 Dissenting views (http://reach.jrc.it/docs/guidance_document/dissenting_en.pdf), questioning the application of the

0.1 % threshold to the entire article have been notified by 6 Member States in writing (Austria, Belgium, Denmark,France, Germany and Sweden) and publication of this part of the guidance document was not endorsed by these Member States.
48 The survey report concerns the release of fragrance substances from children’s play toys including scented markers.

In the report fragrance substances and volatile substances were analysed. The study included a screening of substances
contained in the inner part of the pen as well as the emissions of substances from the pen.

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GUIDANCE FOR ARTICLES - APPENDICES
1

Analysis on fragrances (24 in total) classified as sensitising by EU's Scientific Committee on Cosmetics (SCCNFP 1999). Pens with different smells, Lemon and Strawberry, were examined. The
analysis was done on the inner part containing the fragrance.

2

The pen with lemon scent was examined in an emission test to analyse the release.

3

Screening for extractable organic compounds by GC/MS.

A total of 11 sensitising fragrance substances were found in the analysis on fragrances and substance names
and CAS numbers could be identified. During the emission test various compounds were detected and identified by substance name. Only one substance was identified by name in the screening for extractable compounds. The CAS numbers were searched in an online database for toxicological data (Thomson Microdex).
Classification was searched for in lists from the Danish EPA. It was not possible to find the CAS number for
all the identified substances using the available substance name.

Transferring these results to the importer making a chemical analysis for the children’s toys, although able to identify a few substances by chemical name, from which he could also derive a CAS
number, he may not be able to derive further information on their identity, in terms of their composition. To illustrate the further work process it is assumed that the substance D-limonene, which isa fragrance exceeds the tonnage threshold in the children’s toys of the importer and is thus chosen
for registration.
Check for existing registration

Having the substance name and CAS number available the importer has the possibility to request
the Agency if the substances has been registered. Assuming that it has not been registered, yet theimporter would proceed.
Information on concentration of the substanceIn the Danish survey, the concentration of D-limonene was determined for the inner part of the pen. The classification
was obtained from data bases.

Table 16Further information gathering on D-limonene in the pens (Danish Survey)

Substance

CAS noClassification

Concentration(mg/kg (inner part))

D-limonene

5989-27-5

R10 Xi;R38 R43
N;R50/53

800

Information on amount of substance used

Based on the assumptions for the case of the importer, the quantity of D-limonene in the scented
toys can be calculated as the amount in each toy multiplied by the amount of toys imported annually. The annual amount of D-limonene in the toys is 1.6 kg/a, which is below 1 t/a.
(800 mg/kg , 0.002 kg/toy , 1,000,000 toys/a)
It can also be calculated how many toys the importer can import before reaching the threshold of 1
t/a on D-limonene:
Numberarticle [number of toys/a] <1 [t / a ]= 625 mill. toys/a
1.6 mg / toy

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Illustration of the decision process on registration
Example: Toy with lemon scent (D-limonene)
Consult Chapter 1:
Are you the first EU producer or importer of the object?
YES
Is your object an article?
YES, the company imports toys which are articles, because the shape determines its purpose.
Consult Chapter 4 “Checking if requirements under Article 7 or 33 apply”:
All types of requirements could apply, as substances are released during the use of the article. The release is an additional quality of the toy and the release is therefore intended, otherwise the article would not smell. Furthermore,
SVHC could be contained in the toy as well.
Go to Chapter 5 and 6 on registration of substances intended to be released and on SVHC in articles
As the importer has no information except the results from the chemical analysis he could do the following:1) Collect information on sector knowledge and typically content of substances in this type of article, standards like thetoys directive etc. He would compare that information with the candidate list for authorization and may have doubts
whether he can exclude SVHC. He does not find information on the fragrances intended to be released.
2) Check the supply chain requesting if any of the substances on the candidate list is included in the article / in the substances / preparations used to produce the article or receive confirmation that they are not present in the article. Checkthe supply chain and ask, if the supplier of the fragrance substances can be identified. If yes, he may try to obtain asafety data sheet.
3) Plan and perform screening for substances on the candidate list by analytical methods if no information is obtained
from the suppliers and content of SVHC is likely (! results above)4) Check if identified substances are listed on the candidate list. (The emission test revealed the presence of compounds
classified with R50/53 and R51/53. After establishment of the candidate list the list should be consulted for these compounds, as they may potentially fulfil the criteria as PBT/vPvB).
5) Calculate amount of substances identified in the screening analysis and assess whether the tonnage threshold could
be exceeded for registration
Work process for calculating the amount (Step 5)
1.

Is the total volume of articles > 1 t/a (all articles should be considered and summed up)?

YES. 1 million toys containing 2 g of parts containing fragrance makes the total volume of articles at least 2 t/a.
2.

Total amount of the preparation > 1 t/a (all such articles in a company should be considered)?

YES. The fragrance is included in light felt with very small weight, thus the total volume of fragrance is approx. 2 t/a.
3.
Identify each substance intended to be released from the article.
A total of 11 fragrance compounds were identified to be contained in the toy. During the emission test various compounds were detected and some of the detected compounds were identified with CAS number and classification.
The output from the analysis was the substance name only. The C&L inventory to be established should be consulted inorder to obtain CAS number and classification.
Further steps in this case are focused on D-limonene, which was identified in the chemical analysis.

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GUIDANCE FOR ARTICLES - APPENDICES
4.
Substances exempted from registration?
The guidance should be consulted after establishment to find out if the substance is exempted from registration.
5.
Check for existing registration for that use.
Having the substance name and CAS number available the importer have the possibility to request the Agency if thesubstance has been registered.
6.
Determine the amount of each substance intended to be released (all such articles in a company should
be considered and summed up).
Based on the chemical analysis the content of D-limonene intended to be released is determined to be 800 mg/kg in the
inner part of the toy. The content of D-limonene in the toy is 1.6 mg as the weight of the inner part was 2g.
7.
Total amount > 1 t/a?
Is the total amount of this substance in all such articles in the company above the threshold volume of 1 t/a. It is assumed that this toy is the only article containing D-limonene and imported by the company. The annual amount of Dlimonene is calculated to be 1.6 kg.
Registration of D-limonene is not required for the use in the felt tipped pen

Comments on the caseIn the Danish survey, only pens with two different fragrances were analysed, strawberry and lemon.
In the example, the importer may import toys with several other fragrances, which also have to be
examined. Each individual substance to be released has to be identified.
Only 24 selected fragrances were analysed for content in the article. There are more substances present in the felt tip pen therefore also an emission test was done. In the emission test a range of volatile substances released into the air was identified. Here, only the release was analysed and not thecontent. The emission test did not include the fragrances.
The analysis for fragrances and the emission test, where specific known compounds were searched
for in the entire article (extraction of content of the pen) and in the substances released (emissions
were captured and analysed) was supplemented by a GC-MS screening for extractable organic
compounds, where any compound is detected and characterised by a spectrum. However, the compounds found in the emission test were not found in the GC-MS analysis, hence the content of thevolatile substances could not be determined using this method.
This case illustrates how difficult it is to provide full documentation on substances to be released
from the article based on chemical analysis. If possible the documentation of the identity and quantity of substances to be released from the article should be based on composition of the formulation
used for the article. In case of imported articles the documentation might include supporting documents as letters from the suppliers or by certificates stating the content of e.g. fragrances in the article.

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Case studies on notification of substances in articles according to Article 7(2) under REACH

CASE 1: Clothes

Description

Clothing was selected to exemplify a situation where exposure could be expected. Furthermore, theexample represents a case from a sector subject to high attention and comprehensive knowledge
about chemical substances in their articles. The company NN, which participated in this case, hasalready established a program, which sets demand to the content of dangerous substances in products from their suppliers. This has resulted in a phase-out of SVHC in their textiles.
Criteria for selecting clothes!

Users and application: A large group of users and a wide application; The users include vulnerable groups such as children!

Type of material: Represents a material used in many other articles than clothing, which could
make the case applicable for other producers/importers of articles.

!

Exposure scenarios: An example of possible direct exposure to skin and migration of substances.

!

Supply chain pattern: Represents a supply chain with high degree of imported articles and minor
production within the EU.

!

Documentation: A Swedish company, NN provided information on their import of belt buckles.

Producer/Importer of articles

The selected company imports belt buckles and jewels from a non-EU Member State. Therefore, therole of the company in the supply chain is as EU-importer of articles in relation to the belt buckles.
Substance identity

The company must consult the candidate list for authorisation. This should be done as soon as thelist is made available by the Agency. Metallic lead, which was focused on in this case study, is notclassified in the Annex I of Directive 67/548/EEC. However, an ongoing voluntary risk assessment
is being conducted by the lead industry. It is assumed in the example that metallic lead is a possible
candidate to Annex XIV 49.
The company explained that it is often difficult to obtain complete lists of chemicals from the suppliers. However, this is not necessary when a company has to check whether he has obligations according to the Articles 7(2) and 33. The suppliers could be asked directly about the content of thespecific substances on the candidate list.

49 Note that substances fulfilling the criteria of article 57 can be included on the candidate list only according to theprocedure described in article 59. For more information see the Guidance on Preparing an Annex XV dossier for identifying SVHC and Guidance on Inclusion of Substances to Annex XIV of REACH.

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Check for existing registration

To be done when REACH enters into force.
Information on concentration of the substance

There is no obligation to deliver SDS for articles or other information from non-EU Member States.
The different ways to obtain information suggested in Chapter 4, 5 and 8 of this guidance could beapplied, based on considerations about the simplest way to obtain the information required.
In this case the company has an upper limit for the content of lead in the belt buckles at 0.3% (w/w)
and in their jewellery at 0.01% (w/w). The use of these maximum concentrations in the assessment
will give a worst case scenario.
The alloy used in the buckle was not made known in this case. However, it should be noticed thatthe chemical compositions of most alloys are published as national, European or international standards. If an alloy is not standardized, its chemical composition can usual be obtained by routinechemical analysis.
Information on amount of substance used

The total yearly amount of lead in the articles of the company was estimated on the basis of theamount of belt buckles imported the year before. The calculations were based on the total amount ofbelt buckles imported and the maximum concentration of lead in a buckle at 0.3%.
Illustration of the decision process on registration
Example: Company A - Metallic lead in belt buckles
Consult Chapter 1:
Are you the first EU producer or importer of the object?
YES
Is your object an article?
YES, belt buckles and jewels are articles
Use Chapter 4 “Checking if requirements under Article 7 or 33 apply”:
1.

Is there an intended release from the article

NO
Conclusion for registration: No need for registration.
2.

Does the article contain SVHC - included in the candidate list?

The list has to be checked when it is available. Metallic lead (7439-92-1) is not classified in the Annex I of Directive
67/548EEC but it is a substance with properties of very high concern, which might be included in the candidate list. In
this example it is assumed that it will be on this list.
YES
Go to Chapter 6 “Checking if Article 33 applies and if notification is required”:
1.

Determine the concentration of the SVHC, which in this example is lead

The company limit for lead in jewels is 0.01% (w/w), which is below the threshold limit at 0.1% (w/w). For lead in afunctional item as a buckle the company limit is 0.3% (w/w). Thus the maximum concentration of lead in the buckles
exceeds the threshold limit. It is not possible for the company to analyze large parties of buckles and they assume thatthe concentration in all buckles is 0.3% (w/w). The company imports approx. 13 000 000 buckles per year (in total
approx. 650 different orders/styles).

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Based on experience from tests it is known that most of the buckles contain much less than 0.1% of lead, however, it is
not documented by chemical analysis or certificates from the supplier.
Concentration above 0.1% (w/w)?
YES. Conclusion after this step: communicate information according to Art. 33 and continue to the next step in
the assessment.
2.

Is the SVHC (lead) intended released?

NO. Continue
3.

Has the substance already been registered for that use?

To be checked after REACH has entered into force. It is assumed that lead isn’t registered for that use: + NO.
4.

Determine the amount of the SVHC (lead) present in all articles?

The buckles are the only articles brought into the EU by the company with a lead concentration above the threshold
limit at 0.1%. The total amount of lead brought into the EU per year in all the buckles is:
The import of buckles in 2005: 13,000,000 items
The weight of one buckle: 100 g
The maximum lead concentration in a buckle: 0.3% (w/w)
Calculation of the total lead amount in the buckles in 2005:!

The total amount of lead: (0.3 # 0.01) # (100 #10-6) # 13,000,000 = 3.9 t per year5.

Is the total amount of the lead > 1 t/a?

YES. The total amount of lead brought into the EU-market is 3.9 t/a. This amount exceeds the threshold limit at 1 t/a.
6.

Can exposure be excluded during normal or reasonable foreseeable conditions of use?

The function of the substance in the articles:
A small amount of lead lowers the melting point of the alloy. Lead would almost certainly be present as discrete particles in the matrix of the alloy and as such it would retain its own intrinsic properties.
The use(s) of the article:
Normal use(s): The importer sells the belt buckles to companies, which are producing belts of e.g. leather for both children and adults.
Reasonable foreseeable use(s): If the producer of the belts treats the buckle in such a way that particles are emitted fromthe buckle e.g. at grinding or sand papering, appropriate protection has to be used. If soldering or welding is used, lead
will be emitted in the form of gas and appropriate protection has to be used. Furthermore, children may suck on thebuckle in the end-use situation.
Potential for emission during use(s) and disposal – Look at the routes of exposure:
The routes of exposure in the case of metallic lead are by inhalation and by ingestion. Inhalation can be discounted inthis case. However, it is within the realms of possibility that lead may be transferred from the buckle to the hands of theconsumer and subsequently ingested.
Furthermore, it can not be excluded that there will be a release of lead from the metal buckle after disposal.
Lead has been used in articles for many years. Therefore, it would be obviously to look for further information for ‘thatuse’ of lead in sector organisations, the open literature and databases. Look for emission of lead from buckles and similar materials and exposure of humans and the environment.
Can exposure to humans or environment be excluded?
NO
Conclusion: Notification is required
Go to Section 6.11
Communicate information to the recipients according to Art. 33

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Comment on the case

The case illustrates the possibility of using the maximum concentration or company upper limit of a
specific SVHC in articles as a worst case scenario for assessing whether an importer has an obligation under Articles 7(2) and 33. The use of the maximum concentration leads to the conclusion thatboth notification and communication of information is required. A next step could include a more
precise determination of the lead concentration in the buckle by chemical analysis if applicable. The
information to be delivered within the supply chain, according to Article 33 could e.g. include recommendations of protective equipment to be used during production of the finished belt and instructions on waste handling.
The results obtained completing the workflows 1 and 2 in this guidance could be documented in atable e.g. as in the example above either on paper or electronically. Certificates from suppliers of
the articles stating the limits of the SVHC, results of possible chemical analyses and data of the imported articles volumes could be annexed. Documentation procedures to be followed during the assessment of obligation under Article 7 and 33 could be implemented e.g. as a part of a possible existing quality management system.

99

GUIDANCE FOR ARTICLES - APPENDICESCASE 2: Automotive tyres
Description of the caseTyres were selected as a case due to the existing knowledge about the polycyclic aromatic hydrocarbons (PAHs) contained in high aromatic (HA) extender oils, which are used in the production oftyres. The present case study should, however, not be considered as a complete study covering all
aspect of the use and risks of PAHs in tyres. Furthermore, the case is not based on the knowledge ofa single producer or importer but the sector knowledge within EU.
Automotive tyres are a complex and high-tech safety product that consists of a mixture of synthetic
and natural rubbers, textile and metal reinforcing materials and a wide range of additives (e.g. higharomatic extender oils, zinc oxide, etc) to ensure the finished tyres’ performance, durability andsafety. As tyres are the vehicles' only contact point with the road surface, they are of great importance to road safety. The tyre is here considered to cover both winter and summer tyres for cars,
trucks, buses and trailers.
Users are in contact with new tyres via two routes. One is through the “original equipment market”
where tyres are mounted on the wheels of a new car. The other, is the “replacement market” where
old tyres are replaced with new ones. The retreating market belongs to the replacement market, but
it is a special case as it is only the tread, which is new.
The so-called “End of life tyres” (ELT) are covered by producer responsibility in the majority of
EU member states. These ELT are used for various applications, such as: alternative fuels,
retreating, and material recycling. In Sweden the predominant use of collected tyres is the use asalternative fuel. A smaller part is recycled and retreated. Granulates and shredded tyres could also
be used in civil engineering projects as materials beneath the road surface and beneath buildings.
Criteria for selecting tyres!

User groups and application: Wide spread use.

!

Supply chain pattern: Represent a supply chain with a considerable part (70%) of the production
located within the EU.

!

Exposure scenarios: Exemplifies exposure to environment and a case where substances are contained in wear off from the article.

!

Documentation: Existing knowledge from a former project performed by KemI, Sweden(1994) 50 and information delivered by BLIC (The European Association of the Rubber Industry).

Producer/Importer of articles

The case has not been developed for a specific company but illustrates a general scenario where thetyre is produced within the EU. The scenario is also applicable for imported tyres.
Substance identity

The company must consult the list of the SVHC on the candidate list for authorisation. It should bedone as soon as the list is made available by the Agency (Chapter 6).

50 KemI (1994). Nya hjulspår – en produktstudie av gummidäck (New Wheel Tracks - a product study of rubber tyres).

Report 6/94

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It was decided to focus on the high aromatic (HA) extender oils, which are classified as category 2
carcinogens on the basis of their content of PAHs that are present as impurities in the oil. It is assumed that some of the PAHs will be on the candidate list of SVHC mentioned above.
PAHs are complex ‘group’ of substances and many of them are harmful to health and the environment. They are in fact the largest group in number of carcinogenic substances known today. Manyof their effects are linked to the flat structure of the molecules and their ability to affect the DNA in
the cell nucleus. Most living organisms can convert PAHs, but the products formed during the degradation are often more harmful than the original substance.
Several of the individual PAHs contained in HA oils are classified as category 2 carcinogens in theCommunity wide classification list (KIFS 2001:3). The PAHs’ classified according to this system
are listed in Table 13. Several of them are also included in the Water Framework Directive and international conventions due to their inherent hazardous properties.
It has to be noticed that marketing and use of these HA-oils in tyres will be banned as of the 1st ofJanuary 2010. The tyre industry is currently working on the substitution of the HA-oils, by alternative non-carcinogenic oils.

Table 17

Some important properties of some of the PAHs in HA oil

Substance

Persistent

Bioaccumulative

Antanthrene

Carcinogenic 51 (Cat. 2)(+)

Benzo(a)anthracene

+

+

+

Benzo(a)pyrene

+

+

+

Benzo(b)fluoranthene

+

+

+

+

+

Benzo(e)pyrene
Benzo(g,h,I)perylene

+

+

-

Chrysene+++

Dibenzo(a,h)antracene

+

+

+

Fluoranthene

+

+

-

Indeno (1,2,3-c,d)pyrene

+

+

-

PyreneBenzo(j)fluoranthene
Benzo(k)fluoranthene

+

+

+
+

The criteria for persistence and bioaccumulation originate from the TGD 52
The criteria for persistence and bio-accumulability originate from the TGD 53.
+ = persistent, bioaccumulative or classified as category 2 carcinogenic in the Community-wide classification list (KIFS 2001:3).
(+) = has caused cancer in experimental animals but is not classified as carcinogenic.
? = too few studies are available to assess whether the substance is carcinogenic.
- = negative result.
Blank box = studies lacking.

51 Source IPCS, 1998.
52 Technical guidance document in the program for existing chemicals
53 Technical Guidance Document/Technical guidance document in the programme for existing substances in the EU.

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Check for existing registration

To be done when REACH enters into force.
Information on concentration of the substanceThe content of HA-oils in a tyre depends on which kind of tyres you are looking at. An average passenger car tyre for the EU market contains approximately 600 g of HA-oil. The oil is dissolving in
the rubber mixture but is not reacting chemically. The PAHs content in these HA-oils is less than
400 ppm and the typical average values vary between 100 - 200 ppm.
The concentration of PAHs in tyres was calculated for the worst case scenario and the averagesituation on the bases of the total weight of a tyre and the PAH content of the extender oils (Table
9). The calculation was based on Life Cycle Assessment (LCA) of an average European passenger
car tyre made by BLIC.

Table 18

Calculation of amounts of PAHs in average passenger car tires on the EU market

Weight of an averageinEuropean passenger
the tyre
car tyre
8700 gPAHs content (ppm = µg/g) in the oiloil content

600 g

400

200

100

mg in tyre

% in tyre

mg in tyre%

mg in tyre

%

240

0,003

120

0,001

60

0,0007= 27,6 ppm= 13,8 ppm= 6,9 ppm

The figures in Table 9 show that the total concentration of PAHs in tyre is much below the threshold limit for notification (Art. 7(2)) and communication of information down streams (Art. 33) at
0.1 % (w/w). Therefore, it is obvious that the concentration of individual PAHs is << 0.1%.
Information on amount of the substance produced per company and year

This is not relevant in this case as the concentration limits are not exceeded. This case does not provide any company specific data on production volumes.
Illustration on the decision process for one company checking his obligation according to Articles 7 and 33)
Example: Tyres containing high aromatic extender oils
Consult Chapter 1:
1.

Are you the first EU producer or importer of the object?

YES
2.

Is the object an article?

YES, tyres are articles
Use Chapter 4 “Checking if requirements under Article 7 or 33 apply”
3.

Is there an intended release from the article?

NO
Conclusion on registration: No need for registration

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4.

Does the article contain SVHC – included in the candidate list?

YES. HA oils classified as Category 2 Carcinogen due to their content of PAHs, which are an impurity generated in
the production process of the HA oil. For the purposes of this example, it is assumed that DEHP has been included
on the candidate list.
It shall be noticed, that following the 27th Adaptation to Technical Progress (ATP) of Directive 76/769/EC, themarketing and use of high aromatic oils for the product of tyres will be banned as of 1 January 2010 and a substitution process is ongoing.
Go to chapter 6: “Check if Article 33 applies and if notification is required”
5.

Determine the concentration of the SVHC?

The concentration of the PAHs (group of substances) in the oil is 400 ppm in a worst case scenario and between
100 and 200 ppm (mg/kg) in average. It shall be noticed that this is the value for the PAHs as a group of substances. The concentration of PAHs per tyre from the oil varies between 27 (worst case) and 7 ppm, as illustrated inTable 12. This demonstrates that the PAHs content in the tyre is below threshold at 0.1%.
6.

Concentration above 0.1% (w/w)?

NO + STOP: It is not necessary to continue the assessment process.
Conclusion: Notification is not needed. Communication of information to recipients is not required

Comment on the case

The case illustrates how sector knowledge may be used in the assessment whether a producer/importer has obligation under Articles 7 or 33.
Based on the knowledge of the PAHs content in the aromatic oil applied in the production of tyres,it can be concluded that the concentration of the possible SVHC in the tyre are well below thethreshold limit of 0.1%. Therefore, neither notification according to the Article 7(2) nor communication of information to the recipients according to Article 33 is required.
The results obtained completing the workflows in this guidance could be documented in a table e.g.
as in the example above and the results of chemical analyses and the data for the yearly produced/imported articles volumes could be annexed. The documentation procedures to be applied
during the assessment could be implemented e.g. as a part of a possible existing quality management system.

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GUIDANCE FOR ARTICLES - APPENDICESCASE 3: Bath mattress
Description

The case on bath mattresses presented below illustrated the different steps in the notification process and could be used as a guidance to understand the different steps in the flow chart. Di(ethylhexyl)-phthalate (DEHP) in bath mattresses has been used as an example due to the following
reasons.
Criteria for selecting Bath mattresses!

Users and application: Large user groups. The users include vulnerable groups such as children.

!

Type of material: Represent a material used in many other articles, which could make the caseapplicable for a range of different article producers/importers.

!

Exposure scenarios: An example of possible direct exposure to skin and migration of substances.

!

Supply chain pattern: Represent a supply chain with high degree of imported articles.

!

Documentation: The case is built on a real example but has been adjusted to illustrate the different steps in the notification process.

!

Likeliness for the substance to be included in the candidate list and/or Annex XIV. DEHP is a
CMR substance and may be on the candidate list for eventual inclusion in Annex XIV.

Producer/Importer of articles

The bath mattresses are imported from a non-EU Member State and then distributed to retailers
within the EU.
Substance identity

The physical and chemical properties of the phthalates have made them suitable as plasticizers inpolymers such as plastic and rubber
Plasticizers are not permanently bound to the PVC polymer, and phthalates are therefore released
from plastic products throughout their lifetimes. DEHP are classified as toxic and toxic to reproduction, i.e. they cause reduced ability to reproduce and damage to the unborn child.
The company must consult the candidate list for authorisation. It should be done as soon as the list
is made available by the Agency (Chapter 6). In this example it is assumed that DEHP is a possible
candidate for inclusion in Annex XIV.
Check for existing registration

To be done when REACH enters into force.
Information on concentration of the substanceIn accordance with the legislation the company has substituted DEHP in toys but it is still used assoftener in other articles. The importer of the mattress has been informed that the concentration of
DEHP is 30% (w/w).

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Information on amount of substance used

The total yearly amount of DEHP in the articles of the company was estimated on the basis of theamount of mattresses imported the year before. The calculations were based on the total amount ofbath mattresses imported and the concentration of DEHP in a mattress at 30.0%. (See calculations
below)
Illustration of the decision process on registration
Example: Company B – DEHP in bath mattresses
Consult Chapter 1
1.

Are you the first EU producer or importer of the object in the supply chain?

YES, we import bath mattresses2.

Is your object an article?

YES, the bath mattress is an article
Use Chapter 4 “Checking if requirements under Article 7 or 33 apply”:
3.

Is there an intended release from the article

NO
Conclusion for registration: No need for registration
4.

Does the article contain SVHC - included in the candidate list?

The list has to be checked when available. DEHP is classified as toxic and toxic to reproduction and which are criteria
for inclusion on the candidate list. For the purposes of this example, it is assumed that DEHP has been included on thecandidate list. + YES
Go to Chapter 6: “Check if Article 33 applies and if notification is required”
5.

Determine the concentration of the SVHC, which in this example is DEHP

To determine the concentration limit the company asked their supplier for information. The supplier informed that theconcentration of DEHP was 30% (w/w) in the mattresses. No test protocols were available from the supplier to confirm
concentration levels and the company did not find any reason to question the information given by the supplier.
6.

Concentration above 0.1% (w/w)?

YES. The concentration of DEHP in the bath mattresses exceed the threshold limit at 0.1%
Conclusion for this step: “Communicate information according to Art. 33” and continue to the next step in theassessment.
7.

Communicate information according to article 33

As the bath mattress contains more than 0.1% DEHP and is distributed to retailers within the EU. The company has togive information to allow safe use of the article. Information to be considered as important is the following:!

Substance name: di(ethylhexyl)phthalate!

CAS. No: 117-81-7!

Registration No: not available for the time being!

Classification: R 60-R61 is classified as toxic and toxic to reproduction, i.e. the substance causes reduced ability
to reproduce and damage to the unborn child.

!

Exposure control: Avoid long term dermal contact by children or pregnant women105

GUIDANCE FOR ARTICLES - APPENDICES
8.

Is the SVHC intended to be released?

NO. Continue
9.

WF3: Has the substance already been registered for that use?

To be checked after REACH has entered into force. It is assumed that DEHP isn’t registered for that use: + NO.
10. Determine the amount of the SVHC (DEHP) present in all articles?
The DEHP concentration in the mattresses is > 0.1% and therefore, the total amount of DEHP brought into the EUmarket in the mattresses has to be considered. The total amount of DEHP per year in all imported mattresses is:!

The import of mattresses in 2005: 150,000 items!

The weight of one mattress: 900 g!

The maximum DEHP concentration in a mattress: 30% (w/w)

Calculation of the total DEHP amount in 2005:
The total amount of DEHP: (30 # 0.1) # (900 # 10-6) # 150,000 = 40.5 t per year
11. Is the total amount of the DEHP > 1 t/a?
YES. The total imported amount of DEHP is 40.5 t/a. This amount exceeds the threshold limit of 1 t/a.
12. Can exposure be excluded during normal or reasonable foreseeable conditions of use?
The function of the substance in the articles: Plasticizers are not permanently bound to the PVC polymer, and phthalates
are therefore released from plastic products throughout their lifetimes.
The use(s) of the article:+ Normal use(s): In bath mattresses for adults+ Reasonable foreseeable use(s): It is very likely that the mattresses also will be used by children or fertile women.
Potential for emission during use(s) and disposal – Look at the routes of exposure:
Dermal exposure could be considered to be the most likely way of exposure. It could be assumed that naked skin often
would be in direct contact with the article during use. Exposure through inhalation may occur if the article is used indoors. Exposure through ingestion is also possible as it could be considered to be reasonable foreseeable that children
might suck on the mattress, although due to the size and shape of the product exposure through ingestion is regarded aslimited.
Further more as the product is mainly used in direct sunshine in temperatures above 20 degrees the temperature can be
up to 50 degrees on the material which could contribute to a considerable emission of DEHP.
Can exposure to humans or environment be excluded?
NO
Conclusion: Notification is required
Go to Section 6.11
Communicate information according to Art. 33

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Comment on the case

The case shows how information from the suppliers may be used in the assessment. Notification of
the use of the substances in the article as well as communication of information is required. The
case gives examples on the information to be communicated to the recipients of the article.
The results obtained completing the workflows in this guidance could be documented in a table e.g.
as in the example above. Certificates from suppliers of the bath mattress stating the identity andconcentration limits of the SVHC, potential results of chemical analyses, and the data of the yearly
imported volumes of bath mattress could be annexed. The documentation procedures to be applied
during the assessment of the obligation under REACH could be implemented e.g. as a part of a possible existing quality management system.

107

GUIDANCE FOR ARTICLES - APPENDICESAPPENDIX 5: INFORMATION SOURCES ON SUBSTANCES IN ARTICLESThe list contains examples of available information sources on substances in articles. They provide
various information, e.g. which substances to expect in certain types of articles, which substances
can be ruled out from presence in certain articles, which type of substances can be expected to bereleased from articles etc. It is not a complete list of information sources.
Name
Address
Information sources on substances in miscellaneous articles
Marketing and use restric- COUNCIL DIRECTIVE of 27 July 1976
tions
76/769/EEC
Substances in consumer
products
Eco-Label:
EU flower
German Blue Angel
Nordic Svan
Umweltzeichen
Thai greenlabel
Toxproof certificate

EIS-ChemRisk-Project

http://www.mst.dk/chemi/01080000.htm
http://www.eco-label.com/default.htm
http://europa.eu.int/comm/environment/ecolabel/index_
en.htmhttp://www.svanen.nu/
http://www.blauer-engel.de/
http://www.umweltzeichen.at/
http://www.tei.or.th/greenlabel/
http://www.tuvdotcom.com/pi/web/index.xml

http://web.jrc.ec.europa.eu/eis-chemrisks/

http://appli1.oecd.org/ehs/urchem.nsf
http://www.oecd.org/document/46/0,2340,en_2649_343
73_2412462_1_1_1_1,00.html
http://ecb.jrc.it/biocides/
Information sources on substances in child care productsStandard EN 14350-2
Standards for child-care
products
Mandate to CEN and CENELC in the field of consumer
safety related to the safety of child-care articles (16.
December 1997).
ISO/IES Guide 50 Safety aspects – Guidelines for childsafety (2001)
Information sources on substances in construction material
Construction products,
http://www.aivc.org/frameset/frameset.html?../publicati
AgBB-Approachons/publications.html~mainFrame
http://www.umweltbundesamt.de/bauprodukte/dokumen
te/AgBB-Bewertungsschema2005.pdf
http://www.umweltbundesamt.de/buildingproducts/archive/AgBB-Evaluation-Scheme2005.pdf
Information sources on substances in electrical and electronic equipment
Electrical and electronic
Directive 2002/95/EC on the restrictions of the use of
equipment (EEE), RoHS
certain hazardous substances in electrical and electronic
Directive
equipment
GreenPack
www.greenpack.org
Material Declaration Wiz- www.goodbyechain.com
ard
Information sources on substances in plastic articles – food contact material
http://cpf.jrc.it/webpack/
Food contact material –practical guide
http://europa.eu.int/comm/food/food/chemicalsafety/foo
Emission Scenario Documents

108

Content
Restrictions on use and marketing of substances invarious preparations and articles, e.g. textiles andtreated wood
Survey reports made by national authorities e.g. theDanish EPA
Eco label requirements

Labelling of cars, textiles, furniture, construction
materials, paints; and the mattress & floor covering
to a complete ready-built house
List of substances that can damage health or cause
allergenic reactions
Banned azo-dyes
Substance in products for consumer use. Focus:
human healthOECD's Database on Use and Release of Industrial
Chemicals
ESD on biocides
Limits of the release of certain elements from drinking equipments (EN 14350-2).
The guideline provides migration limits for certain
chemicals regulated in other products.
Chemical substances in toothbrushes (DIN 53160-1)

Substances in construction products and indoor air
quality
CMR substances may not be introduced in to thematerial
AgBB-Scheme in German and English

Six substances are banned in EEE: Pb, Hg, Cd, Cr
VI, PBB and PBDE
Software-tool for electronic articles
Software-tool for electronic articles

Rules for substance in food contact material according to European Directives

GUIDANCE FOR ARTICLES - APPENDICES
Name
Food contact material
Directives on food contact
material

Address
dcontact/practical_guide_en.pdf
http://bfr.zadi.de/kse/
Directive 2002/72/EC

Information sources on substances in textiles
OekoTex 100
www.oeko-tex.com
Information sources on substances in vehicles
ELV and IDIS
Directive 2000/53/EC of 18 September 2000 on end-of
life vehicles (ELV) and International Dismantling Information System (IDIS)

Content
Germany: Recommendations for substances inpolymers
Lists specify the use of substances and possible restrictions for usage
78/142/EEC: limits for the content of vinyl chloride
in a finished material or released by this material
Requirements for substances in textiles

Database/software on car components containing
restricted substances109

GUIDANCE FOR ARTICLES - APPENDICESAPPENDIX 6: INFORMATION SOURCES ON RESTRICTIONS AND METHODS FOR
DETERMINATION OF SUBSTANCES RELEASED FROM ARTICLESThe list contains examples of available sources on information on restricted substances in articles,
declaration duties, chemical analysis of substances banned in articles, standardise release testing
methods and experiences from testing and analyses related to articles. It is not a complete list of information sources.
Product

Identification of substances

Determination ofsubstance content

Miscellaneous articles:
Marketing A list of substances banned for the use in articles in general is provided: Tris(2,3and usedibromopropyl) phosphate, Tris-aziridinyl)-phosphinoxide, penta- and octabromo
restriction
diphenylethers, Polybromo biphenyls(PBB), pentachlorphenol, mercury comfor
pounds, cadmium and its compounds, nonylphenol- and ethoxylates (processing).
textile arti- A list of azodyes, which could by reductive cleavage of one or more azo groups,
cles
may release one or more of the aromatic amines, is provided.
Methods for the determination of certain aromatic amines derived from azo colorants
Part 1: Detection of the use of certain azo colorants accessible without extraction(EN 14362-1:2003)
Part 2: Detection of the use of certain azo colorants accessible by extracting thefibres (EN 14362-2:2003)
Construction products

AgBBApproach

CMR substances may not be introduced into the material

Eco-Label Declaration duties
Type IIIISO TR
14025, RSymbol
ARGE kdR
Substances in vehicles:
ELV and
Database on car components containing
IDIS
restricted substances

110

Declaration duties

Determination ofsubstance release

Requirement for documentationof release during use according
to hygiene, health and the environment. The construction work
must be designed and built insuch a way that it will not be athreat to the hygiene or health ofthe occupants or neighbours.
There are ongoing activities in
CEN to develop standard on
selected substances such as formaldehyde and brominatedflame retardants. The Commission’s Expert Group on Dangerous Substances (EGDS ) areworking on test methods inproduct standards.
Chamber test with single product sample (DIN V ENV 134191 to 3)
thresholds for -carcinogens,
TVOC, -SVOC, individual
substances (list of LCIs included) , -nonassessable substances
Test is similar to emissions tests
for eco-labels
Chemical analysis of potential
emission according to standardised tests

GUIDANCE FOR ARTICLES - APPENDICES
Product

Identification of substances

Toxproof
certificate

Based on a list of substances that can damage health or cause allergic reactions
The procedure of research follows in consideration of experiences from manufacturers and from other fields (indoor air, work
place requirements):
Identification of each material/component
using a received material list.
basic analysis for each material like textiles, leather, plastics
analysis of each material with skin contact
analysis of indoor air
toxicological expert appraisal
Electrical and electronic equipment (EEE):RoHS and Six substances are banned in EEE: Pb, Hg,
WEEE
Cd, Cr VI, PBB and PBDE

Determination ofsubstance content

Determination ofsubstance release

Content testing like:banned azo-dyes (DIN EN 143261/2)

Standardised release testing
methods used:
Static headspace (VDA-norm277) with flame ionisation detector (FID) or mass spectrometry (MS)condensable substances (DIN
75201) gravimetrical method orgas chromatographyodour of emitted components(VDA 270) olfactory test
subskin test (patchtest)

Chemical analysis by existing analytical methods for all applications
Further methods have to be developed.

Wizard and GreenPack:
Material
data bases
IT-Communication toolfor elecSuppliers have to enlist substances in comtronic
ponents
equipment:Child care products and toys:
Standards
Analytical methods are given in the guideline “Child use and care articles – Genfor childeral and common safety guidelines” and Standard EN 14350-2.
care products

Toy safety

Substance lists:
Dangerous substances/ preparations mustnot be used

Plastic articles – food contact material:
Requirements to be considered
practical
guidance
positive lists
on food
purity standards for substances
contact
special conditions of use for substancesmaterial
and/or the materials/articles in which they
are used and SMLs

Chemical analysis
Screening methods

Numerous Standards for identification and quantification of substances
in materials and articles and detailed
rules concerning sample taking andanalytical methods

Standard EN 14350-2 has limitsof the release of certain elementsfrom drinking equipments.
The guideline provides also
migration limits for certain
chemicals regulated in otherproducts.
Chemical substances in
toothbrushes (DIN 53160-1)
The migration of heavy metals,
inorganic and organic
substances can be measured
according to the EN 71-3
standard where the simulant
0.07 M hydrochloric acid (HCl)simulates artificial saliva or
gastric acid.
Analytical method is given in
Survey no. 46 (Chemical substances from tents and tunnels
for children, Wooden toys: Will
be published within August
2005)
Survey no. 14: Mapping ofChemical Substances Discharge
when heating Clay
Software tool Migratest Lite
2001: migration modelfor the simulation in migration
tests. Certain conditions aredefined depending on the material, the food simulant (e. g.
fatty, aqueous), time and temperature111

GUIDANCE FOR ARTICLES - APPENDICES
Product

Directives
on food
contactmaterial

Identification of substances

Determination ofsubstance content

Determination ofsubstance release

Release in the context of thedirectives means a migration ofsubstances from material to thefoodstuff.
Overall migration limit (inmg/dm² as a measure for inertness of the material or mg/kg):
Specific migration limits (SML,in mg/kg or mg/l)
Lists specifying the use of substances:
Directive
Another possible method to exclude a General analysis of overall mi2002/72/E monomers and starting substances additives relevant migration is to measure thegrationC
quantity (Q) of a substance in the(Annex III) andFor detailed information on
finished material or article and toanalytical methods the directive
products obtained by means of bacterial
compare it with the value of its sperefers to other documents like:fermentation (Annex IV)
cific migration (SM) known from82/711/EEC: basic rules necespossible restrictions (Annex V, VI) for
experimentation or valid diffusion
sary for testing migration of theusage.
modelsconstituents of plastic materials
78/142/EEC: limits for the content of and articles
vinyl chloride in a finished material
82/572/EEC: simulates to beor released by this material
used in migration tests
97/48/EEC (temperature andtime)Standards EN 1186 (globalmigration)
Standards EN 13130 (specificmigration)
ESD onEstimation: Potential release asadditivesemission or loss factors overused inservice life:
Plastic
10 additive types (e.g. antioxiIndustry
dants, anti-static agent, colourants) according to their function identified.
The loss is estimated as a percentage of the amount of additives used (dependent on particle
size (threshold value 40 µm) andvolatility (related to the vapour
pressure).
It depends on the application of
the additives and the values ofservice life.
Report formats were used to communicate Quantification methods for cadmium
EUROCAD
content in articles:
Alert and EURASCP system: a report format to inform colleagues inspectors within INAA (instrumental neutron activathe EU and Norway when products with an tion analysis)
exceed limit value of cadmium are found
DIN V ENV 1122
and it seems possible that it is planned to
AAS (atom adsorption spectroscopy),transport them to other EU countries.
XRF (x-ray fluorescence spectrosReport form EuroCad company inspeccopy) and others
tions.
Labelling requirements:
NordicLists of substances excluded from use in
Only general (GLP) requirements forswan forthese products are used.
content analysis on substance identiwriting
fication and quantification are given
supplier has to provide a declaration of
instruments classification, content of named substancesand product composition.

112

In Germany: recommendations for
substances in polymers:
http://bfr.zadi.de/kse/

GUIDANCE FOR ARTICLES - APPENDICES
Product

Identification of substances

Thai Green lists of substances that are excluded fromLabel foruse in certain applications
writing
instruments

Furnishing
Blue Angelfor furniture basedon wood

substance lists exclusion from use in the
product (with declaration from producer)
Documentation of compliance:Blue Angle
for wood
panelsNo use of:wood preservatives (fungicides, insecticides, fire protection agents)
halogenated organic compounds
Documentation of compliance:
Recipe for the production of the woodbased material and of the coating.

Determination ofsubstance content

Determination ofsubstance release

To ensure product quality the following general standards and requirements must be passed:
Thai Industrial Standards or Industrial Standard product quality test as
TISI 346, ball-point pens
TISI 650, black lead pencils
TISI 822, oil based marking pens
TISI 1147, colour lead pencils pens
TISI 1149, wax crayons oran acceptable international /national standard or
the International/national standardised test of product quality andmanufactured, transported, disposed as required by legislation e.g. Factory Act 1992.
Thresholds for
Limit values of emissions from
Formaldehyde in the raw state of the finished furniture Chamber test
wood product, i.e. prior to machining with a sample of the finishedor coating: a steady state, concentra- product or parts of the producttion of 0.1 ppm in the test chamber
Formaldehyde and VOC (subContent of Formaldehyde and TVOC stances are listed) after 24 h +/2hin the finished product
Test Methods for Wood-Based Mate- Formaldehyde and VOC after 28
rials, Federal Health Bulletin 10/91 p. days (it is recommended to takesamples on at least 3 days in
487-483
between)
Identification and quantification
with GC-MS
Official Journal of BAM (Federal Institute for Materials Research and Testing), vol. 29,
1999, p. 234-250
Limit values for the emission ofsubstances. Chamber test withproduct sample
Formaldehyde, VOC and individual substances
Phenol ("Phenol Measurement p-nitroanilin process", VDI Directive 3485)
MDI
phenol-containing binding
agentsIdentification and quantification
with GC-MS

113

GUIDANCE FOR ARTICLES - APPENDICES
Product

Identification of substances

Label forupholsteryand mattresses

The used materials (leather, textiles, upholstery and coating material, adhesives) must
not contain substances that are toxic,
CRM 54, known as a strong contact allergen (leather) 55

NordicSwan for
Furnitureand Fitments

The IKEA
way ofpurchasing

Determination ofsubstance content

Determination ofsubstance release

Chamber test with product sample (according to RAL-UZ 76
wood products, DIN ENV
13419-1, VDA 276)
LANXESS criticises that the
scenario chamber test is very
No use of certain dyes or pigments (subexpensive and time-consuming.
stance list)
They prefer other smaller scaled
The following documents are requested formethods from the automotive
compliance:industry:
recipe for the production of the wood-based
Headspace-method: RAL-GZ
material and, if the occasion arises, of the
479/VDA 277 (PV 3341),
coating.
PB VWL 709/VDA 278 overalltest certificatesemission, for leather used instatement or declaration of the suppliers
cars,
product information for the used materials
RAL-GZ 479/DIN EN 7173/VDA 275 free formaldehyde
in for leather used in cars,
Fogging DIN 75201/ISO 6452
condensable emission for leather
used in cars
Not allowed are:
Methods for detection and measuring of formaldehyde depending on
biocides classified by WHO as Type 1A or material are:
ENV 717 (perforator method)
1B (mandatory) for wood
CMR, toxic, allergenic substances
Finnish classification system: “Emission Classification of building matehalogenated organic substancesrial” 56and Climate Chamber, method, ENV-717-1
heavy metals
Chamber method used for correlation of emission potential (EN 120) as
mg/100 , emission level expressed in ppm or mg/m³
individual substances (substance list)
EN ISO 14184 (emission from padding materials and textiles)
For documentation of compliances:
The producer of wood material shall submit CEN standard 131 ( for adhesives)
information on total amount (in g/kg panel) Nitrosamines: chamber test (ENV 13419-1 after 24 h and 30 h) or ZH
of chemical substances classified as enviISO 1/120.23 57 for air sampling; Thresholds forronmentally harmful. The supplier has toemissionand content: formaldehyde
classify the constituents.
substances harmful to the environment
aromatic solvents
organic solvents and substances classified environmentally harmful (e.g.
quantity per m² surface
IKEA provides a negative list of subContent and release analysis is carRelease analysis (e.g. chamber
stances, which must not be used by its sup- ried out to control whether products
tests) are also carried out topliers.
comply with IKEA specification on
identify potential risks related tochemical compounds (see below).
long term exposure of subIKEA demands a minimum chemicals
stancesmanagement system of its suppliers, including listing all chemicals used.

54 According to Directive 67/548/EEC annex I, GefStV, TRGS, MAK- und BAT-Werte-Liste
55 List of the German BfR(https://gripsdb.dimdi.de/websearch/servlet/Gate?accessid=bfrKABasic&language=de#__DEFANCHOR__)56 http:www.rts.fi/emission_classification_of_building_materials.htm
57 Hauptverband der gewerblichen Berufsgenossenschaften

114

GUIDANCE FOR ARTICLES - APPENDICES
Product

Identification of substances

ESD ontextilesA total release is estimatedfor volatile substances to theatmospherefor biocides from indoor articles
to wastewater through cleaning
for biocides from outdoor articles to wastewater and soil.
Testing methods to control comTesting methods for detection of banned
Testing methods to control compliance with thresholds for:pliance with thresholds for:substances (substance lists)
content of pesticides and chlorinated release of heavy metals underphenols
artificial perspiration conditions
formaldehyde or containing trace
For pigment, vat or sulphurous
amounts (significantly lower than the colorants a minimum grade ofrequired legal limits)colour fastness to rubbing of 3(dry) is acceptable
Documentation includes a manufacturing
Analysis of chemicals and emissions by laboratories which are accredsystem diagram with
ited according ISO 17025.
flow diagram and list of all suppliers
Test methods/standards are indicated in the criteria documents (content
list of used chemicals, dyes and pigments in and release)
Named substances are prohibited (substance list)
the product
Thresholds for individual substances
As a reference system ChemTest is part of the toolbox and provides
available analytical methods suitable to close data gaps remaining in theknowledge based analysis.
Development and validation of biomarkers are key issues of EISChemRisks (low dose biomarkers).
Tool working with ExpoScenarios as standard scenarios.
The focus of EIS-CHEMRISKS will be to evaluate the feasibility ofusing data derived from modelling activities in the EU and in the world.

Oeko-Tex
100

EU-Flower
for textiles

ChemRisk

Determination ofsubstance content

Determination ofsubstance release115

GUIDANCE FOR ARTICLES - APPENDICESAPPENDIX 7: LEGISLATION RESTRICTING THE USE OF SUBSTANCES IN ARTICLESInstrument

Coverage

Conditions

Notes

Directive 76/769/EEC

Placing on the market
and use of hazardous
substances in Annex I

Restrictions on marketing anduse of substance, may containexemptions

Restrictions will be taken up
in Annex XVII of REACH((also see Art 137 on transitional measures regarding
restrictions)

Biocidal products!

!

The use of certain biocides is restricted by Directive76/769/EEC; and!

restrictions of non-active
substances should beunder Directive
76/769/EEC.

Marketing and use
restrictions Directive

Directive 98/8/EC
Biocides Directive!

Substances included in Annex I may be used as active
substances in biocidal products, Annex I may contain
substance specific conditions; andAuthorisation of biocidal
products at national level.

Directive 94/62

Packaging and packaging waste

Concentration limits for heavy
metal content in packaging materials

Directive 76/768

Cosmetics

List of banned and permitted
substances for use in cosmetic
products

Directive 842/2006

Greenhouse gases

Restrictions on fluorinatedgreenhouse gases

Directive 89/106 on
construction products“New approach” Directives

Contains general provisions on
the materials from which the
products covered can be made,especially specifying that theyshould not affect health of users
and/or not release toxic gases

Directive 89/686 on
personal protective
equipment
Directive 93/42 on
medical devices
Directive 98/79 on invitro diagnostic medical devices
Directive 90/385 on
active implantable
medical devices

116

This also has a provision on
bioavailability of substances inthe devices

GUIDANCE FOR ARTICLES - APPENDICES
Instrument

Coverage

Conditions

Notes

Electrical and electronicequipment falling undercategories set in Annex
IA to Directive
2002/96/EC (Waste
Electrical and Electronic
Equipment)!

New equipment may notcontain Pb, Hg, Cd, Cr(VI),
PBB, PBDE; andStakeholder consultation on
proposals for additional exemptions ongoing!

exemptions listed in an Annex.

Amendment
2006/690/EC

The use of Pb in crystal
glass in specific materials and components usedin electrical and electronic equipment!

Exemptions for applicationsof Pb in crystal glass

Amendment
2006/691/EC

Exemptions for applications of Pb and Cd inelectrical and electronicequipment!

Exemptions granted basedon a review process

Amendment
2006/692/EC

Exemptions for applications of Cr(VI) in electrical and electronicequipment!

Exempted until 1/07/2007

Directive
91/157/EEC, Directive 98/101/EC

Batteries and accumulators

Marketing of batteries and accumulators containing morethan 0,00005 % of Hg prohibited (exemption: more than 2 %of Hg in button cells)

The revision of the directives
is under preparation. Directive 2006/66 will replace
Directive 91/157 as of
26/9/2008

The use of Pb, Hg, Cg andCr(VI) is prohibited in vehicles
and their components.

The directive aims to reduce
the amount of and risks from(hazardous) waste from disposal of ELVs. The IDIS
software is designed from car
manufacturers for providing
information to dismantlingcompanies about the content
of the four banned heavy
metals in car components

Environment-Other
Directive 2002/95/EC
Restriction of Hazardous Substances(RoHS) Directive

Directive 2000/53/EC
End-of-life vehicles(ELVs) and International Dismantling
Information System(IDIS)

Stakeholder consultation on
proposals for additional exemptions ongoing

Consumers
General Product
Safety Directive(GPSD) 2001/95/EEC

All consumer products
or aspects of those products that are not coveredby specific European
safety legislation

A number of measures, including published standards andcodes of good practice may betaken into account in assessing
safety.

Products must provide thesafety which consumers canreasonably expect.

Directive 88/378/EEC

Toys as defined in Article 1

Limit values for bioavailabilityof metals resulting from the useof toysUse of certain substances intoys restricted by Directive
76/769/EEC

Elastomer or rubber teats
and soothers

List of permitted, authorised andbanned nitrosamines and Nnitrosatable substances in elastomers or rubber teats andsoothers

Toys Directive
Directive 93/11

117

GUIDANCE FOR ARTICLES - APPENDICES
Instrument

Coverage

Conditions

Directive 89/107/EEC

Additives to be used infoodstuffs

Positive list of substances (onlythese to be used in foodstuffs
and only certain conditions
specified therein)

Materials and articles
intended to come into
contact with foodstuffs

In Annex I groups of materials
and articles are listed whichshall be subject to specific directives.

Aims to ensure that all materials and articles in their finished state that come in contact to foodstuffs do nottransfer substances in quantities that endanger humanhealth or bring an unacceptable change in the composition of the foodstuffs (Art.
2).

Plastic materials andarticles intended to comeinto contact with foodstuffs

Positive lists with authorised
substances which excludes allothers from use in a certain application.

The aim of a positive list of
substances is to protect consumer against health risks
due to exposure to substances migrating into food

Food additives

Directive
1935/2004/EEC
Food Contact Materials

Directive 2002/72/EC
Plastic Food Contact
Materials

Annex II ‘monomers and otherstarting substances’
Information on impurities insubstances and constituents of
mixtures
Overall and specific migration
limitsDirective 84/500
Ceramic food contact
materials

Directive 78/142
Food Contact Materials

Directive 93/10
Food Contact Materials

Directive 1895/2095
Food Contact Materials

118

Symbol that may accompany materials andarticles intended to comeinto contact with foodstuffs

determining the symbol that may
accompany materials and articles intended to come into contact with foodstuffs

Materials and articles
intended to come into
contact with foodstuffs

Migration limits for vinylchloride monomer in food contact
materials

Materials and articles
intended to come into
contact with foodstuffs

Migration limits for cellulose infood contact materials

Materials and articles
intended to come into
contact with foodstuffs

Contains list of permitted substances
Food contact materials containing epoxy derivatives

Notes