REACH

Factsheet

ECHA-12-FS-07-EN
Key information for recipients of substances covered by Article 2(7) of the REACH Regulation

Communication obligations for certain substances exemptedfrom registration under REACH
The aim of this fact sheet is tofamiliarize the reader with the factthat some substances can be legallyplaced on the market without aregistration number and with theinformation he can expect from his
supplier concerning in particular
those substances which benefit fromthe exemption from registrationaccording to Article 2(7) of REACH.
Manufacturers or importers that can rely onArticle 2(7) of the REACH Regulation
regarding the exemption of a substance fromthe registration provisions can legally place on
the market such a substance without
submitting a registration dossier. In such asituation, the manufacturer or importer will
not obtain a registration number andconsequently will not be able to communicate
such a registration number in the supplychain.
Companies that wish to benefit from such an
exemption must assess whether theirsubstances qualify for the exemption. They
also have to provide the authorities (onrequest) with appropriate information toprove that their substances fulfil theexemption conditions.

Once it has been established that a substancecan be legally placed on the market althougha registration number may not be available, afurther obligation applies. The supplier of such
substances has a duty to communicate
information down the supply chain to his
recipients to enable them to use thesubstance safely.

SUBSTANCES EXEMPTED FROMREGISTRATION UNDER ARTICLE
2(7)The following substances are exempted fromthe registration obligations:! Substances included in Annex IV tothe REACH Regulation as they present
minimum risk because of their intrinsic
properties (e.g. water, nitrogen);! Substances covered by Annex V to theREACH Regulation as for thesesubstances (substances occurring innature, e.g. minerals, ores and ore
concentrates if they are not chemicallymodified) registration is deemed
inappropriate or unnecessary;! Substances already registered andrecovered through a recovery process
in the EU;! Substances already registered andexported from and re-imported into
the EU.

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The specific conditions under which theabove-mentioned exemptions fromregistration under REACH apply are describedin detail in the ECHA Guidance on registration(section 2.2.3).

ACTORS CONCERNED
Information included in this document may be
relevant for any actor involved in the supply
chain of a substance exempted under any ofthe provisions of Article 2(7). Since
exempted substances may be placed on themarket without indicating a registration
number, this factsheet is addressed inparticular to:! recipients (including downstream users
using the substances in their professional
and/or industrial activity) who are notcertain if the substances they receive arelegally placed on the market;! suppliers who have to provide theircustomers with a safety data sheet (anSDS) or other sufficient information on thesafe use of a substance they supply incase no SDS is required.
In some cases distributors (includingretailers) may find this information useful,since they also contribute to the flow ofinformation in the supply chain.

WHAT INFORMATION CAN I
GENERALLY EXPECT FROM MYSUPPLIER?
Safety data sheet
A supplier has to provide an SDS, whenever
the substance (on its own or in a mixture)
falls within one of the following categories:! it meets the criteria for classification as
hazardous in accordance with theRegulation on classification, labelling andpackaging of substances and mixtures(CLP Regulation) or the mixture containing
the substance is classified as dangerous inaccordance with the Dangerous
Preparation Directive (DPD);! it is persistent, bioaccumulative and toxic(PBT) or very persistent and very
bioaccumulative (vPvB) in accordancewith Annex XIII of the REACH Regulation;! it is included in the candidate list ofsubstances which may be subjected toauthorisation.

A supplier has also to provide on request an
SDS for any mixture which does not meet thecriteria for classification as dangerous but
which contains:! !1% (by weight) for non-gaseous
mixtures (or !0.2% by volume for agaseous mixture) of a substance posing
human health or environmental hazards;
or! !0.1% (by weight) for non-gaseous
mixtures of a PBT or a vPvB substance inaccordance with Annex XIII; or! a substance for which there are
Community workplace exposure limits.
Please note that the SDS does not have to besupplied if a hazardous substance or
dangerous mixture is offered or sold to thegeneral public and provided with sufficient
information to use the substance safely unlessspecifically requested by a downstream user
or distributor. It follows that SDSs are only
for professional users.
For more information on which substancesand mixtures SDSs needs to be provided forand by whom, please consult the Guidance on
the compilation of safety data sheets.

Extended SDS
In some cases actors in the supply chain will
be provided with one or more exposure
scenario(s) (ES) attached to the SDS for asubstance or mixture. This may happen if asubstance is subject to registration for
quantities of 10 tonnes or more per year. In
this situation the registrant is required toperform a chemical safety assessment (CSA)
to ensure that the risks arising from themanufacture and use of a substance areunder control. The results of a CSA are thendocumented in a chemical safety report(CSR). The final ES is an integral part of CSR
and it is developed for all identified uses.
Once a relevant ES is completed it has to becommunicated to you and other downstream
users of the registrant as an annex to theSDS – thus creating a so-called “extendedSDS”. The ES will provide appropriate
instructions on risk management measures(RMM) that you should apply in order toensure control of risks.
However, actors should be aware that not all
registrants who are required to carry out aCSA and prepare a CSR are necessarily
required to prepare an ES. For example,

ANNANKATU 18, P.O. BOX 400, FI-00121 HELSINKI, FINLAND | ECHA.EUROPA.EUalthough a CSA and a CSR is generally
required for all substances subject toregistration in quantities of 10 tonnes ormore, an ES is only required for those which
fulfill the criteria for any of the hazard classes
or categories set out in Article 14(4) of theREACH Regulation or are assessed to be a
PBT or vPvB.
Furthermore, the CSA and CSR would
normally be carried out as part of thepreparations for a registration by the relevant
deadline. The ES for a particular substance on
its own or in mixture will therefore normally
only be attached to SDS after the relevant
substance has been registered.
To learn more about the information contentof the ES please see the Guidance on
information requirements and chemical safetyassessment. Part D: Exposure Scenario
Building.
You may also find useful to consult Practicalexamples of exposure scenarios available on
the ECHA website.

Other information
According to Article 32(1) of the REACH Regulation when supplying a substance or a mixture for which an SDS is not required suppliers still have to communicate the following
information:

Substances covered by Annex IV andV of the REACH Regulation
If the conditions of Article 2(7)(a) or Article2(7)(b) of the REACH Regulation (concerning
substances listed in Annexes IV or V of theRegulation because either sufficient
information is already known about them orregistration is deemed inappropriate or
unnecessary, respectively) are met for asubstance, it is exempted from theregistration provisions and can be legallyplaced on the market without a registration
number. Please note that the registration
number refers to the submission of a specificregistration dossier for a substance by eachmanufacturer or importer. Therefore,
recipients of substances that have not beenregistered by their manufacturer or importer
because the exemptions according to Article2(7)(a) or 2(7)(b) apply will not receive aregistration number from the manufacturer orimporter of these substances.
As mentioned before, a CSR documenting theCSA is only needed for substances subject toregistration in quantities of 10 tonnes or more
per year per registrant. As a consequence forsubstances that are exempted fromregistration the CSA and CSR are not neededat all. Therefore, if you are the recipient ofsuch a substance you will not receive an ES
as part of the safety data sheet.

!

if the substance is subject toauthorisation and the details of thegranted or denied authorisation or appropriate information if authorisation
has been denied;

For more explanations and backgroundinformation on applying the different
exemptions and clarifications as to when an
exemption could or cannot be applied, please
consult the Guidance on Annex V.

!

the details of any restriction imposed;

Recovered substances!

any available and relevant information
about the substance that is necessary
to enable appropriate risk management;!

the registration number if available
for any substances for which information is communicated as outlined
above.

A recovery operator who establishes thesameness of a substance with one alreadyregistered and who possesses the required
information according to Articles 31 or 32 of
REACH is exempted from registration of that
substance and consequently does not have toperform a CSA or complete a CSR for thesubstance. Therefore, even if the registrationof the same “original” substance does notcover its use as a recovered substance, therecovery operator is not required to prepare
an ES for the use of the recovered substance.
It should be recalled, however, that therecovery operator must in any case provide
relevant and adequate safety information toallow safe use of the recovered substance.

WHAT CHANGES IN CASE
ARTICLE 2(7) APPLIES?
There are however substances for which yoursupplier is not required to provide you withall information listed above. These arediscussed further below.

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When placing a recovered substance on themarket, a recovery operator does not have toindicate a registration number, as he is
exempted from the provisions of Title II ofREACH. Therefore, if you are recipient of arecovered substance that has not beenregistered by the recovery operator because
the exemption of Article 2(7)(d) of the REACH
Regulation applies, you will generally notreceive:!

a registration number;!

an ES for the subsequent downstream
uses within the new life cycle chain after the recovery has taken place;from the manufacturer of the recovered substance as part of the SDS or as an attachment
to it.
However, please be aware that according to
the provisions of Article 32(1) of REACH it
may be required, to provide a registration
number free of charge if this is available to
the recovery operator.
To learn more about the conditions underwhich legal entities recovering substancesfrom waste can benefit from the exemption
laid down in Article 2(7)(d) and their
obligations to share information in the supply
chain please consult the Guidance on waste
and recovered substances.

Re-imported substances
In cases where a substance is firstmanufactured in the EU, then exported andthen brought back into the EU again this could
lead to a double registration obligation if it
happens within the same supply chain.
Therefore, substances which have beenregistered according to Title II of REACH,
exported and then re-imported are exemptedfrom registration under the following
conditions:-the substance must have beenregistered before it was exported fromthe EU;-

the substance already registered andexported must be the same as thesubstance being re-imported;-

the substance must not only be thesame but it must actually proceedfrom the same supply chain in which
the substance was registered;-

the re-importer must have been
provided with information on theexported substance, and that
information must comply with therequirements established under REACH
for the provision of information down
the supply chain.

The re-importer will need to havedocumentation showing that the substance is
identical to that registered in the EU by him
or someone in his supply chain. The samenessof the substance must be assessed according
to the criteria defined in the Guidance on
identification and naming of substances under
REACH and CLP.
Furthermore, in order to avoid a double
registration obligation, the re-importer needs
to have available an SDS, or otherinformation required by Article 32 relating tothe exported substance. The re-importer canshow this by tracing and documenting thesupply chain and identifying the originalregistrant of the substance.

WHERE CAN I FIND FURTHERINFORMATION AND SUPPORT?
National REACH helpdesks offer practicaladvice in local languages:
http://www.echa.europa.eu/nationalhelp/
Industry associations often also provide
information and support to their members.

LINKS TO RELATED MATERIAL
REACH Regulation EC No 1907/2006
REACH Guidance: this section of the ECHA
website is a single point of access to generaland detailed technical guidance on REACH.
Guidance Fact Sheets and Frequently Asked
Questions can be found in the “support”
section of the ECHA website.
© European Chemicals Agency, 2012

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