REACH

Factsheet

ECHA-13-GF-06-EN
Information for parties involved in contractual arrangements for toll manufacturing.

Toll manufacturer under the REACH Regulation
For business reasons (e. g. economic
advantage, staying competitive,
logistics) a company may decide tooutsource (some of) its
manufacturing operations to a third
party. The nature of such contractual
arrangements between companies is
described using a broad range ofterminology. “Toll manufacturer” is
one of the most frequently used terms
for describing a second company
carrying out an activity on behalf of afirst in cases where the activity is
manufacturing. The activity iscorrespondingly described as toll
manufacturing and is a common
practice in the chemicals industry.
The REACH Regulation does nothave specific provisions on toll
manufacturing. Nevertheless, toll
manufacturers may have obligations
under the Regulation.
The aim of this fact sheet is to explain
the concept of a toll manufacturer
and the responsibilities that he may
have under the REACH Regulation.
This document also briefly describes

relevant REACH requirements. It
additionally gives some initial advice
on how compliance may be facilitated
for toll manufacturers and forcompanies who are contracting
others to toll manufacture on theirbehalf.
Toll manufacturing agreements may
be very different in scope andarrangements. It is strongly
recommended that such agreements
explicitly address the REACH
obligations related to manufacturing
activities in the EU - as a minimum
the registration obligation. Provisions
for ownership of data, future updates,
responsibility for compiling andproviding Safety Data Sheets (SDSs),
as well as other relevant REACH
obligations should be clearlyaddressed in the contractual
agreements. Similarly obligations forcorrect classification, packaging andlabelling of the substances or
mixtures subject to the agreement
under the CLP Regulation should also
be addressed in the agreements.

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WHO IS A TOLL MANUFACTURER?
A toll manufacturer is normally understood tobe a company providing manufacturingservices (for a fee) to another company, on
the basis of a contract for provision of thoseservices. The following terms are also used todescribe such activity:• Outsourced manufacturer;• Third party service provider;

In general, the customer usually owns theprocess technology and know-how as well as
the end product(s). This fact differentiates atoll manufacturing agreement from a standard
supply contract.

WHAT ARE THE TOLLMANUFACTURER’S OBLIGATIONSUNDER REACH?
Registration of substance• Custom chemical manufacturer;• Supplier of outside services;• Contract manufacturer;• Toller.

WHAT IS TOLL MANUFACTURING?
Toll manufacturing (or tolling) implies thatprocessing of materials takes place. The toll
manufacturer’s services can include forexample:-manufacturing of a substance;-

formulation;-

blending;-

separation;-

distillation;-

centrifugation;-

a combination of the above.

Storage or distribution may accompany the
tolling operations, but do not themselves
constitute toll manufacturing.
Toll manufacturing arrangements may differ
subtantially from case to case.

ACTORS CONCERNED
A toll manufacturing agreement involves twoparties:• Company procuring the tolling service(“the customer”, also called “theprincipal”) that may provide raw
materials, chemical process informationand necessary instructions.
• Toll manufacturer (provider of service)
who (depending on the situation) provides
infrastructure, required equipment,
operating staff and technical support.

There is no definition of a toll manufacturer inthe REACH Regulation. The Regulation offers
no specific rules or provisions for this actor.
Therefore, for REACH purposes, a toll
manufacturer is to be considered in the same
way as any other EU-based manufacturer
that conforms to the definition in Article 3 (9)of REACH, i.e. as a:• natural or legal person established within theCommunity who manufactures a substancewithin the Community
and the activity of manufacturing is definedin Article 3 (8) as:• production or extraction of substances in thenatural state

According to Article 6 (1) of REACH, any
EU-manufacturer of a substance in a quantityof one tonne or more per year must register
the substance, unless specific exemptions
apply 1. This includes substances on their own,
in mixtures or substances in articles when
they are intended to be released undernormal or reasonably foreseeable conditionsof use.
If the above-mentioned criteria for registration are met, it is the toll manufacturer
who has the registration obligation under
REACH, despite the fact that the customer
owns the raw materials, intellectual property
and end product(s).
The issue of who should bear theadministrative burden of registration andassociated costs needs to be agreed between
the two actors. The toll manufacturer may not
be capable of taking on such costs. Also, thecompany procuring the tolling services may
want to control the registration, as it often
1

For more information on exemptions from REACH
provisions, please consult sections: 2.2.2, 2.2.3 and2.2.4 of the Guidance on registration.

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holds the registration data and confidential
business information concerning thesubstance and its uses.
As long as this is not in conflict with the
obligations of the manufacturer under REACH,
the practical arrangements can be madebetween both parties in any way satisfactory
to both parties. For example, the customer
may decide to compile the registration dossierand pay for the registration costs. Also there
may be a contractual agreement between thecustomer and the toller covering data
ownership and containing provisions whereby
one or both parties commit to compensate theother for any loss, damage, or legal liability
that may arise out of the agreement. Since
toll manufacturing circumstances vary frombusiness to business, each scenario should be
judged on a case by case basis, allowing forpractical solutions. It should be noted that
there may be a need to review and update
the content of the registration dossier
following a request from authorities or as aresult of new information becoming available.
Both parties should pre-define clearly how to
act in case of such update needs.

manufacturer (i.e. raw materials used in theprocess). This information should be indicatedby the supplier of the substance, usually inthe safety data sheet (SDS). If the substanceis listed in Annex XIV to the REACH
Regulation (List of substances subject toauthorisation), the toll manufacturer must
check whether or not he needs to apply for an
authorisation for his use. However, if anauthorisation for this specific use has been
granted to an actor up his supply chain (e.g.
the customer) the toll manufacturer may
benefit from it (provided that he uses thesubstance according to the conditions of an
authorisation granted to an actor up his
supply chain).
For more information on the authorisation
process, please consult the Guidance on the
preparation of an application for authorisation
and Questions and Answers on application forauthorisation. It is also advised to view
the Authorisation section on the ECHA
website.

Requirements for safety data sheets(SDSs)In addition to the registration obligation, theREACH Regulation defines other
responsibilities for manufacturers whichtollers will have to comply with. The following
paragraphs explain some of these obligations.

Article 31 (1) of the REACH Regulation,requires the supplier of a substance or a
mixture to provide an SDS formatted according to Annex II of REACH, whenever:Toll manufacturing and substances
subject to restriction

a substance:

If the toll manufacturer is contracted to
manufacture a substance, he also needs toensure that manufacture, placing on themarket or use of this substance is not
restricted by Annex XVII (Restriction on the
manufacture, placing on the market and use
of certain dangerous substances, mixtures
and articles) of the REACH Regulation.
For more information about restrictions,please consult the Guidance for the
preparations of an Annex XV dossier for
restrictions. It is also recommended to visit
the Restriction section on the ECHA website.

Toll manufacturing and authorisation
provisions
The authorisation requirements may apply tothe substances that are used by the toll-meets the criteria for classification as
hazardous in accordance with theRegulation on classification, labelling andpackaging of substances and mixtures(CLP Regulation); or-

is persistent, bioaccumulative and toxic(PBT) or very persistent and very bioaccumulative (vPvB) in accordance with
Annex XIII of the REACH Regulation; or-is included in the candidate list of substances which may be subjected to authorisation.

or a mixture:- meets the criteria for classification as
dangerous in accordance with the Dangerous
Preparation Directive (DPD) 2;
2

Note that from 1 June 2015 also the criterion for mixtures will be based on the CLP Regulation.

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A supplier is defined in Article 3 (32) of
REACH as "any manufacturer, importer,
downstream user or distributor placing on
the market a substance, on its own or in a
mixture, or a mixture". With regard to the
REACH definition of placing on the market(“supplying or making available, whether in
return for payment or free of charge, to athird party”) substances (or mixtures) madeavailable to the customer (i.e. the third party)
by the toller can be considered to have beenplaced on the market. Therefore, the toll
manufacturer is the supplier of a substance(or mixture) and the customer or a DU of thecustomer is the recipient. The toll
manufacturer is thus formally responsible forproviding the SDS for thesubstance(s)/mixture(s) that he manufactures
to the customer. However, if agreed between
the parties, the compilation of the SDS can be
carried out by the customer.
Note that even if the substance is notclassified as hazardous, or the conditions ofArticle 31 for when an SDS must be provided
are not fulfilled, the supplier may undercertain conditions have to provide therecipient with other information according to
Article 32 of the REACH Regulation.
For more information on for which substancesand mixtures SDSs need to be provided andby whom, please consult the Guidance on thecompilation of safety data sheets.

Obligation to keep information
As is the case for any other EU-based
manufacturer, a toll manufacturer is required
according to Article 36 of REACH to collectand keep available all the information herequires to carry out his duties under REACH.
The toll manufacturer should be able todemonstrate REACH compliance upon requestof (inspecting/enforcing) authorities or ECHA.
Depending on the service provided by the toll
manufacturer, the set of such information
may vary. For toll manufacturers carrying out
manufacturing as defined in REACH thisinformation may include for example:• SDSs of substances/mixtures that are
manufactured for the customer and madeavailable to the customer or third parties;• SDSs of substances/mixtures that are
made available by the customer to the toll
manufacturer;• registration numbers of all substances
manufactured (provided that they requireregistration);• any other information on substances
made available to the customer or third
parties as required by Article 32 of
REACH;• invoices and proof of payment concerning
fees for registration of manufactured
substance(s);• copy of tolling contract;• the toll manufacturer should also be able
to document the volume of each
substance that he manufactures.

CONFIDENTIALITY
Toll manufacturing agreements may be
confidential. In particular the customer may
not want to reveal to his final clients theidentity of the toll manufacturer or to disclosethat there are other tollers acting on hisbehalf.
If both actors are situated within the EU, thecustomer may use the possibility given by
Article 4 of REACH (General provision) and act
as a Third Party Representative (TPR) for
discussions with other registrants within the
Substance Information Exchange Forum(SIEF) for a phase in substance. The toll
manufacturer might appoint the customer asa TPR. In this case the identity of theregistrant (i.e. the toll manufacturer) will not
be disclosed to other manufacturers orimporters by ECHA in the inquiry process. As
a TPR, the customer will be a visible
participant in discussions in any SIEF for theindividual substances concerned. However,when concluding SIEF agreements andagreements for access to data the specificstatus of the TPR needs to be taken into
account. It needs to be ensured that theactual registrant (i.e. the toll manufacturer),
who is represented by the TPR, also himself
obtains permission to refer to the data in the
joint registration.
Moreover, both sides of the toll manufacturingagreement should bear in mind that when thecustomer acts as a TPR, he (like all TPRs)
cannot register a substance for the company
he represents (i.e. the toll manufacturer). In
such cases, the registration itself has to bemade by the toll manufacturer (in his own

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name). The role of the TPR is limited tomaintain anonymity in the SIEF discussions(so that other SIEF members do not know
who the actual manufacturer is). The (toll)
manufacturer legally remains the registrant.
When preparing a registration dossier, theregistrant (toll manufacturer) can claim
certain information contained in the SDS(such as the company name) as confidential
for the purposes of dissemination of
information from the registration dossier by
ECHA. This possibility is given by Article 119(2) (d) of the REACH Regulation. The
registrant needs to submit a justification as towhy publishing this information would be
potentially harmful to his commercial
interests or to the commercial interests of any
other party concerned. The fact that theregistrant is not acting as a direct supplierand has appointed a TPR is a supporting
factor in this situation. Such a confidentiality
claim must be accompanied by thecorresponding fee according to Annex IV of
the Fee Regulation. The justification will beassessed by ECHA in accordance with Article
119 (2) of the REACH Regulation. Where it isaccepted as valid, the information concerned
will not be revealed by ECHA during
dissemination of information from registration
dossiers or for data sharing purposes.
For further instructions please consult section
4.3.4 of the Data Submission Manual Part 16- Confidentiality Claims.
For more information about appointing a TPR,
data sharing obligations and SIEF formation,please consult the Guidance on data sharing.

supply chain of the OR appointment (so theywould know who the non-EU toll manufactureris). However, this problem does not arise if
the customer acts as a sole importer.
A non-EU manufacturer can only appoint one
OR per substance. An OR can represent
several non-EU manufacturers of the same
given substance, but would then need toregister the substance separately for eachlegal entity he represents for that substance(i.e. by creating separate UUIDs for each legal
entity he represents and by submission of aseparate registration for each of those legal
entities). This makes appointing an OR by the
non-EU toll manufacturer more complicated incase the non-EU toller manufactures several
different substances for several customers.
For more information about appointing an
only representative and his role and duties
under REACH, please consult section 2.1.2.5of the Guidance on registration.

CHANGE OF TOLL MANUFACTURER
A company procuring tolling services should
also be aware of legal consequences whenchanging the toll manufacturer to a different
company (different entity).
According to Article 22 (1) (a) of REACH anychange in the identity of a registrant has tobe notified to ECHA. If the change also
involves a change in legal personality of theregistrant, it triggers the need to update theregistration dossier and for payment of an
update fee according to Regulation (EC) No
340/2008 4 (the Fee Regulation).

It may also be the case that the toll
manufacturer is located outside the EU, andthe customer inside the EU. In such asituation, the customer is an importer andmay register the substance in this role 3. Thisway the customer both owns the registration
dossier and controls the registration.

If the company procuring the tolling services
decides to transfer toll manufacturing to adifferent company, it cannot be treated simply
as a change of legal personality, unless there
is a legal link between the old and the newlegal person. Therefore, in such a case a newregistration accompanied by the relevant
fee would be required.

Another option could be to appoint thecustomer as an Only Representative (OR)of the non-EU toll manufacturer. Note that
Article 8 (3) of the REACH Regulation requires
the non-EU manufacturer (i.e. the toller) to
inform all the EU importer(s) within the same

A new registration accompanied by therelevant fee may also be required if there is achange of a non-EU toll manufacturer which
has appointed an OR. In such a case it iseither the EU importers or a new OR

3
It is not an option for the non-EU toll manufacturer toregister a substance, as only an EU legal entity canregister a substance under REACH.

4
As amended by the Commission Implementing Regulation (EU) No 254/2013 of 20 March 2013.

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appointed by the new non-EU toll
manufacturer that needs to register.
If the new toll manufacturer (or therespective new OR or importer) is the firsttime manufacturer (or importer) of a phase in
substance in a quantity between 1-100 tonnes
per year (and the substance is not classified
as CMR category 1 or 2, or as very toxic toaquatic organisms which may cause longterm adverse effects in the aquatic
environment (R50/53) in accordance with
Directive 67/548/EEC 5) he can still benefit
from "late" pre-registration up to 31 May
2017, within 6 months of first manufacturing
in a quantity of 1 tonne or more per year.
This possibility is foreseen under Article 28(6) of the REACH Regulation. Note that latepre-registration does not apply for non-phasein substances.

REACH Regulation EC No 1907/2006
CLP Regulation (EC) No 1272/2008
Fee Regulation (EC) No 340/2008 as
amended by Commission Implementing
Regulation (EU) No 254/2013 of 20 March
2013.
REACH Guidance: this section of the ECHA
website is a single point of access to generaland detailed technical guidance on REACH.
Guidance in a Nutshell: this section of the
ECHA website contains a series of shortened
versions of the REACH guidance documents tomake the corresponding full guidance
documents published by ECHA moreaccessible for industry.
Guidance Fact Sheets and Frequently Asked
Questions (FAQs) can be found in the“support” section of the ECHA website.
For the current FAQ on toll manufacture (as at
July 2013) see: FAQ link.

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.
5

Directive 67/548/EEC has been replaced by Regulation(EC) No 1272/2008 (the CLP Regulation). 67/548/EEC
will be fully repealed with effect from 1 June 2015. Until
then there are transitional provisions in place in accordance with Article 61 of CLP. The reference to classification
contained in this text applies to the concept of harmonised classification of substances listed in Part 3 of Annex
VI to the CLP Regulation and self-classification in accordance with Article 4 of the CLP Regulation.

© European Chemicals Agency, 2013

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ED-02-13-214-EN-C – DoI:10.2823/88049 – ISBN: 978-92-9244-004-6

For more information on legal entity change,
it is recommended to consult REACH-IT
Industry User Manual Part 17 – Legal Entity
Change. This manual provides an overall
context for legal entity change, defines somekey terms and summarises the duties ofcompanies with respect to changes of nameand changes of legal personality. It also
describes the use of those functionalities
required by industry to comply with the
REACH Regulation when a company changes
its legal personality. For more specificinstructions on how to report a change inlegal entity, please consult Practical Guide 8:
How to report changes in identity of legal
entities.

LINKS TO RELATED MATERIAL