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REACH

Scope of REACH

Does REACH apply to substances (either on their own, in mixtures or in articles) manufactured or imported in volumes below 1 tonne per year?

Yes, because besides registration there are several obligations under REACH that apply irrespective of tonnage. These include restrictions, authorisation and communication in the supply chain (such as the provision of safety data sheets). The one tonne per year threshold applies to registration only.

To identify your obligations, we recommend you to use the Navigator tool: http://echa.europa.eu/support/guidance-on-reach-and-clp-implementation/identify-your-obligations

Do substances used in biocides and plant protection products (PPP) have to be registered under REACH?

Active substances for use in biocidal products are regarded as already registered, as biocidal products and their active ingredients are covered by Regulation (EU) 528/2012 (Biocidal Products Regulation). However, several conditions have to be fulfilled to benefit from the exemption. These conditions are laid down in Article 15(2) of the REACH Regulation and explained in section 2.2.4.1- 'Substance for use in biocidal products' of the Guidance on registration http://echa.europa.eu/guidance-documents/guidance-on-reach.

Active substances for use in plant protection products (PPPs) are regarded as registered as the plant protection products and their active ingredients are covered by Regulation (EC) 1107/2009. Please note that even though co-formulants are mentioned in Article 15(1) of the REACH Regulation, currently they do not meet the conditions laid down in this Article. Therefore co-formulants used in plant protection products do not qualify for the exemption and are not regarded as registered. This is further explained in section 2.2.4.2- 'Substance for use in plant protection products' of the Guidance on registration http://echa.europa.eu/guidance-documents/guidance-on-reach.

It is important to note, that only the quantities of the active substance for use in biocidal products and for use in PPPs are considered registered under REACH. Thus, if the substance is not used as an active ingredient in a biocidal product or a PPP, then the exemption would not apply to this other use and the quantity of the substance for the non-biocidal or non-PPP use would have to be registered.

 

Does REACH apply to substances occurring in nature or to their synthetic analogues?

REACH applies both to substances occurring in nature, as defined by Article 3(39) of REACH, and to their synthetic analogues.

However, Annex V to REACH states that the following substances occurring in nature are exempted from registration if they are not chemically modified: minerals, ores, ore concentrates, raw and processed natural gas, crude oil and coal. These substances can only be processed by certain means (e.g. dissolution in water, flotation), which are specified in Article 3(39) of REACH and do not include chemical modification (Article 3(40)).

Other substances occurring in nature are also exempted from registration if they are not chemically modified, unless:

  • they meet the criteria for classification as dangerous according to the CLP Regulation (Regulation 1272/2008), or
  • they are persistent, bioaccumulative and toxic or very persistent and very bioaccumulative in accordance with the criteria set out in Annex XIII, or
  • they were identified in accordance with Article 59(1) at least two years previously as substances giving rise to an equivalent level of concern as set out in Article 57(f).

Further explanations and background information on the different exemptions in Annex V are included in section 2.2.3.4 - 'Substances covered by Annex V of the REACH Regulation' of the Guidance on registration: http://www.echa.europa.eu/guidance-documents/guidance-on-reach

The REACH Registration Q&As provide guidance on substances occurring in nature that are obtained by extraction processes.

For particular guidance on polymer substances occurring in nature, see section 3.2.1.3 - 'Case of a natural polymer or a chemically modified natural polymer' of the Guidance for monomers and polymers: http://www.echa.europa.eu/guidance-documents/guidance-on-reach

Since the synthetic analogues of naturally occurring substances do not meet the criteria for substances occurring in nature as defined in Article 3(39) of REACH, any manufacturer or importer of these substances in quantities of one tonne or more per year is required to register them.

 

 

Are modified substances derived from substances listed in Annex IV also exempt from registration?

Substances listed in Annex IV to REACH are exempt from registration. Modified substances derived from these substances are also exempt if the modified substance is still covered by the same EINECS entry; whether the same EINECS entry applies is a case-by-case decision. For example, for plant oils such as soybean oil (EINECS no 232-274-4; CAS no 8001-22-7) the physically modified derivatives are explicitly covered in the EINECS entry. Whereas chemical modification (e.g. hydrogenation) is not mentioned and hence considered not to be covered. For further information, see Article 3(40) of REACH and Section 2.2.3.3- 'Substances included in Annex IV of the REACH Regulation' of the Guidance on registration: http://echa.europa.eu/guidance-documents/guidance-on-reach

Do substances at nano-scale fall under the scope of REACH?

Yes, they do and their health and environment properties must be assessed in accordance with the provisions of the REACH Regulation. Potential registrants should first consider whether they have obligations under REACH, irrespective of the particle size of the substances. Once it is established that the substance falls within the scope of REACH, further investigation of the detailed provisions of REACH may indicate that different provisions apply according to the hazard properties associated with the particle size of the substances. The evolving science of nanotechnology may necessitate further requirements in the future to reflect the particular properties of nanoparticles.

 

Which substances have to be registered?
Registration is required for all substances:
- as defined in Article 3(1) of REACH;
- manufactured in or imported into the EU in quantities of 1 tonne or more per registrant per year;
- unless they are exempted from registration or regarded as being already registered, according to provisions in Articles 2, 9, 15 or 24 of the REACH Regulation;
- irrespective of whether they are classified as dangerous or not.
If you want to know whether you have to register a substance you should first consult section 2.2- 'What to register?' of the Guidance on registration. There you will also find information on substances exempted from registration: http://echa.europa.eu/guidance-documents/guidance-on-reach.
In addition, the Navigator tool can help to clarify the registration obligations for your specific substance: http://echa.europa.eu/support/guidance-on-reach-and-clp-implementation/identify-your-obligations.
Do I have to register alloys?
The REACH Regulation refers to alloys as "special mixtures" (Recital (31), Annex I (0.11.), as amended by Regulation (EC) No 1272/2008). Therefore, an alloy is to be treated in the same way as other mixtures under REACH, which means that the alloy as such is not subject to registration but the alloying elements (e.g. metals), irrespectively of the production process of the alloy are. However, components which are not important for the properties of the alloy should be considered as impurities (i.e. they are part of a substance in the mixture) and therefore need not be registered separately. Please note that intermetallic compounds are often wrongly regarded as alloys, although they have a well defined stoichiometry. Such substances are listed in EINECS (e.g. "aluminium, compound with iron (1:1)", "iron, compound with titanium (2:1)", etc.) and cannot be regarded as mixtures, therefore these intermetallic compounds have to be registered as such. This means that e.g. separate (pre-)registrations of the substances Al and Fe do not cover the substances "aluminium, compound with iron (1:1)" or "aluminium, compound with iron (1:3)". For each intermetallic compound with a different metal ratio a separate (pre-)registration is required.
Do I have to register intermediates?

It depends under which type of intermediate as described under Article 3(15) of the REACH Regulation your intermediate falls, whether you have registration obligations or not.

  • Non-isolated intermediates:

For the use of a substance as a non-isolated intermediate, there are no obligations under the REACH Regulation.

  • On-site isolated intermediates:

A manufacturer of on-site isolated intermediates in quantities of 1 tonne or more per year needs to register their substances (if they are not otherwise exempted from registration (see FAQ ID=30). However registrants of on-site isolated intermediates can provide reduced registration information according to Article 17(2) of the REACH Regulation if they confirm that the substance is manufactured and used under strictly controlled conditions as described under Article 17(3) of REACH.

  • Transported isolated intermediates:

A manufacturer or importer of transported isolated intermediates in quantities of 1 tonne or more per year needs to register his substances if they are not otherwise exempted from registration. However, a registrant of transported isolated intermediates can provide reduced registration information according to Article 18(2) of the REACH Regulation if he confirms that he is manufacturing and/or using the substance under strictly controlled conditions and if he confirms or states that he has received confirmation from the user that the substance is used under strictly controlled conditions as described under Article 18(4) of REACH. In this case, both the registrant and the users are each liable for their own statement regarding the strictly controlled conditions.
When and how the specific provisions for the registration of intermediates under REACH can be used are described in the Guidance for intermediates: http://echa.europa.eu/guidance-documents/guidance-on-reach.

More information can be found at: http://echa.europa.eu/documents/10162/13655/pg16_intermediate_registration_en.pdf
 

Do I have to register a substance occurring in nature if I have to apply a process to extract this substance?
Substances occurring in nature are exempted from the duty to register in accordance with Article 2(7)(b) and Annex V, point 8 of REACH, as long as they are not chemically modified, not classified as dangerous in accordance with Directive 67/548/EEC, nor substances of very high concern, such as PBT or vPvB substances. If a process is applied to extract such a substance, it has to be verified whether the process applied is one of those listed in Article 3(39) of the REACH Regulation. If this is the case, the substance still qualifies as substance that occurs in nature that does not have to be registered.
The processes mentioned in Article 3(39) of REACH are manual, mechanical or gravitational processes, dissolution in water, flotation, extraction with water, steam distillation, heating solely to remove water and extraction from air. Please note that extraction with solvents other than water, like e.g. hexane or ethanol, are not covered by Article 3(39) of REACH. Substances which are extracted with these solvents do not qualify as a substance that occurs in nature and cannot be exempted from registration on the basis of Annex V, point 8 of REACH.
Lavender oil, for example, is extracted from flowers of certain species of lavender (which occur in nature) by means of steam distillation. The subsequent spontaneous separation of oil and water allows an easy isolation of the lavender oil. As this extraction process is mentioned in Article 3(39) of REACH, the lavender oil can be regarded as a substance that occurs in nature.
On the contrary, chrysanthemum oil, for example, which is extracted from chrysanthemum blossoms and leaves (which occur in nature) with a solvent mixture of water and ethanol (1:10), cannot be regarded as a substance that occurs in nature.
In general, it is important to remember that it is up to the manufacturer to assess the process applied and to determine if the definition of Article 3(39) of REACH is applicable or not.
What falls under the definition of PPORD (Product and Process Oriented Research and Development)?
According to Article 3 (22) of the REACH Regulation PPORD is defined as "any scientific development related to product development or the further development of a substance, on its own, in preparations or in articles in the course of which pilot plant or production trials are used to develop the production process and/or to test the fields of application of the substance".Any scientific development of a substance consisting of, for example, campaign(s) for the scaling-up, improvement of a production process in a pilot plant or in the full-scale production, or the investigation of the fields of applications for that substance, falls under the definition of PPORD irrespective of the tonnage involved.
In order to promote innovation, Article 9 of the REACH Regulation specifies that substances manufactured or imported on their own or in mixtures, as well as substances incorporated in articles or imported in articles for the purpose of PPORD can be exempted from the duty to register for a period of 5 years. To be exempted a company needs to submit a PPORD notification to the ECHA. Upon request, ECHA may further extend this exemption for up to another 5 years, or 10 years for the development of medicinal products (for human or veterinary use) as well as for substances that are not placed on the market. Further information is provided by the specific Guidance on Scientific Research and Development (SR&D) and Product and Process Oriented Research and Development (PPORD): http://echa.europa.eu/guidance-documents/guidance-on-reach.
Have PORD exemptions under Directive 67/548/EEC been transferred into REACH?

National Process Orientated Research and Development (PORD) exemptions for the notification of substances under Directive 67/548/EEC are no longer valid under REACH since 1 June 2008, because there are no such notifications under REACH. Therefore, to benefit from the registration exemption, manufacturers or importers of substances or producers of articles wishing to continue their PORD activities need to submit a PPORD notification (REACH, Article 9). For guidance on how to prepare and submit a PPORD notification in practice, please consult the Data Submission Manual 1, available at:

http://www.echa.europa.eu/support/dossier-submission-tools/reach-it/data-submission-manuals

Will a registration under the REACH Regulation be required for substances that are manufactured within the EEA but exported 100% outside of the EEA?
Yes. Article 6 of the REACH Regulation requires a manufacturer of a substance in quantities of more than 1 tonne per year to submit a registration, irrespective of whether this substance will subsequently be exported outside of the EEA. Therefore, substances manufactured in the EEA above this limit that do not meet any of the criteria for exemption from registration in accordance with Article 2 of the REACH Regulation and which are subsequently exported to non-EEA countries must be registered. The rationale for this duty is that the exposure resulting from manufacture and any other activity before export could be relevant for workers and the environment in the EEA.
Do I have to register chemically surface treated substances?
The surface treatment of a substance is a "two dimensional" modification of macroscopic particles. A "two dimensional" modification means a chemical reaction between the functional groups only on the surface of a macroscopic particle with a substance which is called a surface treating substance.By this definition it becomes clear that this kind of modification means a reaction of only a minor part (surface) of a macroscopic particle with the surface treating substance, i.e. most of the macroscopic particle is unmodified.
Therefore a chemically surface treated substance cannot be regarded as a mixture nor be defined by the criteria of the Guidance for identification and naming of substances under REACH: http://echa.europa.eu/guidance-documents/guidance-on-reach.
With the same reasoning, a chemically surface treated substance could not be reported for EINECS nor be notified according to Directive 67/548/EEC because it was covered by the separate EINECS entries of both the basis substance (macroscopic particle) and the surface treating substance.Taking this decision up under REACH means a consequent continuation of former decisions. Using the same line of arguments, chemically surface treated substances should not be registered as such under REACH, but the following requirements should be fulfilled:
1. Registration of the basis substance (macroscopic particle)
2. Registration of the surface treating substance
3. Description of the use "surface treatment" in the registration dossier of the surface treating substance and in the registration dossier of the basis substance
4. Any specific hazards or risks of the surface treated substance should be appropriately covered by the classification and labelling and by the chemicals safety assessment and resulting exposure scenarios.
Do I have to register substances used in medicinal products?
According to Article 2(5)(a) of the REACH Regulation substances used in medicinal products for human or veterinary use within the scope of the relevant EU legislation are exempted from the Registration Title of the REACH Regulation (Title II). More explanation is provided for in Section 2.2.3.2- 'Medicinal products' of the Guidance on registration: http://echa.europa.eu/guidance-documents/guidance-on-reach.
Substances fulfilling the conditions of Article 2(5)(a) of the REACH Regulation are also exempt from the Titles on Downstream Users, Evaluation and Authorisation (Titles V, VI and VII of the Regulation).
Importantly, substances are exempted from these Titles only to the extent that they are used in medicinal products in accordance with Regulation 726/2004, Directive 2001/82 and Directive 2001/83. Quantities of the same substance used for other purposes are not exempted.
The exemption covers the manufacture (in the EU) of substances in medicinal products that are exported; and the manufacture (in the EU) of active substances within the scope of EU legislation on medicinal products that are exported. The exemption also applies to imports of substances in medicinal products and imports of active substances within the scope of the EU rules on medicinal products.
Intermediates that are not present in the medicinal product (as defined in Regulation 726/2004, Directive 2001/82 and Directive 2001/83) are not exempted from registration. 
Is a metal hydroxide manufactured from the metal oxide covered by the exemption from registration in Annex V, point 6 of the REACH Regulation?
According to Annex V, point 6 of the REACH Regulation hydrates of a substance or hydrated ions, formed by association of a substance with water are exempted from registration, provided that the substance (i.e. the anhydrous form) has been registered by its manufacturer or importer.
 
Hydrates of a substance are characterised by the fact that water molecules are linked by molecular interactions, in particular by hydrogen bonds, to other molecules or ions of the substance. For the purposes of Annex V, hydrates and water free forms (anhydrous) of compounds shall be regarded as the same substance (e.g. CuSO4.5H2O and CuSO4).
 
In contrast, a metal hydroxide (e.g. Ca(OH)2) and a metal oxide (e.g. CaO) cannot be regarded as the same substance as both substances have different structures, regardless of the manufacturing process. The formation of the hydroxide involves forming new covalent bonds, which is different from forming a hydrate which only involves weak intermolecular bonds. Therefore a metal hydroxide manufactured from the metal oxide is not covered by the exemption from registration in Annex V, point 6.
Are substances that are banned under Regulation (EC) No. 2037/2000 (on substances that deplete the ozone layer) subject to (pre-) registration?

Yes. Substances are not exempted from (pre-)registration on the grounds that they are within the scope of Regulation (EC) No. 2037/2000 on substances that deplete the ozone layer. FAQ ID=30 explains which substances have to be (pre-)registered.

Is a registrant required to update their registration dossier with a new analysis dataset each time the substance is imported from a new non-EU manufacturer?
There is no explicit legal obligation for registrants to update their registration dossier every time an import is made from a new non-EU source. However, according to Article 22(1)(b) of REACH, there is a legal obligation to update the composition of the substance as given in Section 2 of Annex VI. The registrant has to assess the sameness of the substance every time an import of the substance is made from a new source, according to Guidance for identification and naming of substances available on the ECHA website.
There are three possible outcomes of this assessment:
 
1. Registrants find that the substance has the same impurity profile as previous imports and is already registered by them. They do not have to update the registration dossier for the substance.
 
2. Registrants find that the substance has a different impurity profile from previous imports. They then have to update the relevant sections of the registration dossier (e.g. concentration ranges or changes in C&L) with the new composition of the substance.
What are the options for an importer of a mixture when he is unable to obtain the relevant information from his supplier on the components of the mixture?
To fulfil his duties as a registrant an EEA-based importer of mixtures has to have information on the composition of the mixtures he imports into the EEA. This obligation already existed under the previous legislation as regards substances to be classified as dangerous. Under REACH, an importer needs to know at least the identity and percentage content of all substances in the mixtures he imports that could exceed the amount of one tonne/year.
 
If the non-EEA supplier is not willing or not able to provide the required information, the importer has the following options:
- identify the formulator of the mixture (if different from the supplier) and ask him directly for the required information,
- propose to the non-EEA formulator that he appoints an only representative in accordance with Article 8 of the REACH Regulation,
- establish the composition of the mixture by analytical means,
- find an alternative supplier who is prepared to provide all required information for the mixture.
What are the duties of registrants that cease manufacture and import?
If a registration for a substance has been submitted, the obligations to update the registration (Article 22) and to keep information (Article 36) apply. This means that a registrant ceasing manufacture and import of this substance has to inform the Agency about the new total tonnage manufactured and imported (in this case zero t/a). Furthermore this registrant has to keep available all the information he required to carry out his duties under REACH for a period of at least 10 years after he last manufactured, imported, supplied or used the substance (as such or in a mixture). In this regard, the period of at least 10 years does not start if the registrant, who ceased manufacture and import, still supplies or uses the substance.
Who can benefit from the phase-in scheme?

Manufacturers and importers who have manufactured a substance in any of the current Member States of the EU at least once after 31 May 1992 (15 years before the entry into force of REACH) and never placed it on the EU market can benefit from the phase-in scheme. This benefit also applies if you were a manufacturer before the entry into force of REACH and became an importer after it.

For all other manufacturers and first time importers who did not manufacture the substance in the EU, the substance is considered as a non-phase-in substance.
 

Is biomethane obtained by the purification of biogas exempted from registration under REACH?

Yes, biomethane obtained by the purification of biogas is considered to be covered by the exemption from registration according to Annex V entry 12 to REACH. This exemption does not refer to biomethane as such, but to biogas (consisting mainly of methane) produced by the biological breakdown of organic matter (e.g. agricultural waste, municipal waste, sewage) in the absence of oxygen. Nevertheless, biomethane obtained by the purification of biogas to remove undesirable components is still considered as biogas and is, therefore, exempted from registration according to Annex V entry 12 to REACH.

For methane processed from raw natural gas, the exemption in Annex V entry 7 to REACH applies. Methane obtained from other sources than fossils is not regarded as natural gas and is, therefore, not covered by this entry. 

Do chromic acids and their oligomers, generated in water from chromium trioxide, require their own registration under REACH?

When brought in contact with water, chromium trioxide (EC number 215-607-8) forms two acids and several oligomers: Chromic acid (EC number 231-801-5), Dichromic acid (EC number 236-881-5), Oligomers of chromic acid and dichromic acid.

These chemical species are identified as substances of very high concern (SVHC) and included in the Candidate List1 as two separate entries.

Chromic acids and their oligomers generated in water from chromium trioxide are commonly referred to as an aqueous solution of chromium trioxide. With regard to the obligation to register, it may be justifiable in some specific situations described in the table below, to consider for practical reasons chromic acids and their oligomers as an aqueous solution of chromium trioxide. Hence, in these specific cases, chromic acids and their oligomers present in an aqueous solution of chromium trioxide can be covered by a registration dossier for chromium trioxide.

Important note: The presented approach is strictly limited to chromium trioxide and chromic acids and their oligomers generated from chromium trioxide in water. It derives from very specific aspects of the Chromium VI aqueous chemistry; the system in aqueous solution is a complex equilibrium between multiple chemical species which depends on several physico-chemical parameters and the different chemical species cannot be isolated from the aqueous solution. The approach can thus not be applied by analogy to any other substance.

Manufacturers and importers of chromium trioxide and chromic acids and their oligomers have to consider the following situations:

 

Actor / Scenario Legal requirement Explanation
Manufacturer or importer of chromium trioxide who generates chromic acids and their oligomers in water One registration according to Article 10 for chromium trioxide

The generation of chromic acids and their oligomers by adding chromium trioxide to water and their further use have to be included in the registration dossier and have to be considered for the chemical safety assessment (CSA) and the chemical safety report (CSR).

In case a downstream user (DU) generates chromic acids and their oligomers from chromium trioxide, this use has to be communicated up the supply chain and has to be included in the registration dossier.

Importer of both chromium trioxide and chromic acids and their oligomers generated in water from chromium trioxide

One registration according to Article 10 for chromium trioxide The registrant has to register chromium trioxide and chromic acids and their oligomers in one dossier for chromium trioxide. It has to become clear from the registration dossier that chromic acids and their oligomers are also imported. Therefore, at least two compositions have to be provided in section 1.2 of the IUCLID dossier. The first composition refers to chromium trioxide; the second composition refers to the composition of chromic acids and their oligomers. A remark has to be entered to clarify the approach.  The tonnage to be reported is the aggregated tonnage of both chromium trioxide and chromic acids and their oligomers. The tonnage has to be reported on the basis of equivalent chromium trioxide tonnage. 
Importer of chromic acids and their oligomers generated in water from chromium trioxide Registration according to Article 10
either for chromic acids and their oligomers generated from chromium trioxide
or for chromium trioxide

In case the importer decides to register chromic acids and their oligomers in a dossier for chromium trioxide, it has to become clear from the registration dossier that what is actual imported are chromic acids and their oligomers.

Therefore at least two compositions have to be provided in section 1.2 of the IUCLID dossier. The first composition refers to the generic substance "chromium trioxide"; its purity and composition should be indicated as 100 %. The second composition shall refer to the actual composition of chromic acids and their oligomers which are imported. A remark has to be entered to clarify the approach.  
Manufacturer or importer of chromic acids and their oligomers generated by alternative methods other than from adding chromium trioxide to water
or
Importer who is unaware of the manufacturing methods of the chromic acids and their oligomers
Registration according to Article 10 for chromic acids and their oligomers The approaches described above cannot be applied as the starting material for manufacturing chromic acids and their oligomers is not chromium trioxide or is not known. 

 

Please, also see Q&A=805 (Can an application for authorisation for chromium trioxide cover the use of the chromic acids and their oligomers generated from adding chromium trioxide to water?)

How do I determine who is responsible for importing ?

You should register if you are the legal entity established in the EU who is responsible for importing.

The responsibility for importing depends on many factors such as:

  • Who orders?
  • Who pays?
  • Who is dealing with the customs formalities?
    However, this might not be conclusive on its own.

Example
A sales agency established in the EU that acts as an intermediary, i.e. they transmit orders from buyers to non-EU suppliers (and are paid for this service). However, they take no responsibility for the goods or the payment of the goods and do not own the goods at any stage. In this case, the sales agency is not considered to be an importer for the purposes of REACH. The sales agency is not responsible for the physical introduction of the goods.

In many instances, this will be the ultimate receiver of the goods (the consignee) who is the legal entity responsible for importing the goods.

For further information and examples see chapter 2.1.2.4 "Who is responsible for registration in case of import?" in the Guidance on registration:

How do I document the re-import of a registered substance?

Substances which have been registered, exported and then re-imported are exempted from registration under certain conditions.

To benefit from this exemption, you need to document that the following conditions are fulfilled:

  1. The substance must have been registered before it was exported from the EU.
  2. The substance already registered and exported must be the same, as the substance being re-imported.
  3. The substance must not only be the same but it must actually proceed from the same supply chain in which the substance was registered.
  4. The re-importer must have been provided with information on the exported substance as required by REACH (e.g. safety data sheet).

For further information, see chapter 2.2.3.6 "Re-imported substance" in the Guidance on registration:

What are my duties as an only representative?

As an only representative, you are fully responsible and liable for fulfilling all obligations of importers for the substances you are responsible for. These do not only pertain to registration but also to all other obligations of importers under REACH. As an only representative, you need to register the imported quantities depending on the contractual arrangements with the ‘non-EU manufacturer'.

You can represent one or several ‘non-EU manufacturers'. If you act on behalf of several ‘non-EU manufacturers', you must submit a separate registration for each of these manufacturers.

Your registration dossier should contain all uses of the importers covered by the registration. You need to keep an up-to-date list of importers within the same supply chain of the ‘non-EU manufacturer' and the tonnage covered for each of them, as well as information on the supply of the latest update of the safety data sheet.

For further information see chapter 2.1.2.5 "Only representative of a non-EU manufacturer" in the Guidance on registration:

How is a polymer defined under REACH?

A polymer is a substance consisting of molecules characterised by the sequence of one or more types of monomer unit. Such molecules must be distributed over a range of molecular weights. Differences in the molecular weight are primarily attributable to differences in the number of monomer units.

Under REACH, a polymer is defined as a substance meeting the following criteria:

  1. Over 50 percent of the weight consists of molecules containing at least three monomer units which are covalently bound to at least one other monomer unit or other reactant; and,
  2. The amount of molecules presenting the same molecular weight must be less than 50 percent of the weight.

For further information see chapter 2.2.3.7 of the Guidance on registration:

Full details on polymers are available in the Guidance for monomers and polymers:

Which substances are covered by Annex V?
Annex V of REACH lists thirteen broad categories of substances for which registration is deemed inappropriate or unnecessary. The registration exemption applies to the substances as such, provided however that they meet the conditions for the exemption which are given in the particular category of Annex V.
 
If you need more detailed information on any category of substances, you can find this in the Guidance for Annex V, which gives explanations and background information for applying the different exemptions and clarifies when an exemption can be applied and when not.
 
Which substances are exempted from registration in the interest of defence?

In specific cases, REACH allows individual Member States to exempt certain substances from the application of REACH, in the interests of defence.

More information on national exemptions in the interest of defence in individual Member States is available on the European Defence Agency website:

How is a non-isolated intermediate defined under REACH?

A non-isolated intermediate is defined as an intermediate that during synthesis is not intentionally removed (except for sampling) from the equipment in which the synthesis takes place.

For further information see the Guidance on registration:

Which substances used in food or feedingstuffs are exempted from registration?

When a substance is used in food for humans or feedingstuffs for animals in accordance with the Food Safety Regulation ((EC) No 178/2002), the substance does not have to be registered.

This includes the use of the substance:

  • as a food additive in foodstuffs (Council Directive 89/107/ECC);
  • as a flavouring in foodstuffs (Council Directive 88/388/ECC and Commission Decision 1999/217/EC);
  • as an additive in feedingstuffs (Regulation (EC) No 1831/2003);
  • in animal nutrition (Council Directive 82/471/EEC).

Amounts of the same substance used for other uses than food and feedingstuffs are not exempted from registration. Only the amounts of the substance used in food and feedingstuffs are exempted from the registration obligation under REACH.

For further information, see chapter 2.2.3.1 of the Guidance on registration:

Which substances used in medicinal products are exempted from registration?

When a substance is used in a medicinal product within the scope of either:

  • The Regulation on Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency ((EC) No 726/2004); or
  • The Directive on the Community code relating to veterinary medicinal Products (2001/82/EC); or
  • The Directive on the Community code for medicinal products for human use (2001/83/EC); the substance does not have to be registered under REACH for that use.

The exemption does not distinguish between active or non-active ingredients as it applies to any substance ‘used in medicinal products'. Excipients used in medicinal products are therefore also exempted from registration.

Amounts of the same substance used for other uses than pharmaceuticals are not exempted. Only the amounts of the substance used in medicinal products are exempted from the registration obligation.

For further information, see chapter 2.2.3.2 of the Guidance on registration:

Which substances used in biocidal products are regarded as registered?

Active substances manufactured or imported for use in biocidal products are regarded as registered for the use in that biocidal product in the following situations:

  • The active substance has been approved in accordance with Regulation (EU) No 528/2012 ("BPR"), or
  • The active substance is under assessment in the review programme of existing active substances established under Article 16(2) of Directive 98/8/EC and continued under Article 89 BPR.

The list of approved active substances is available from the ECHA website:

To check which active substances are in the review programme, please see Annex II, part I to Commission Delegated Regulation (EU) No 1062/2014, also available from the ECHA website:

http://echa.europa.eu/regulations/biocidal-products-regulation/approval-of-active-substances/existing-active-substance

An exemption from REACH registration also applies in the following cases:

  • The active substance is manufactured/imported for use in a biocidal product which has a simplified authorisation (Article 27 BPR)
  • The active substance is manufactured/imported for use in a biocidal product which has a provisional authorisation (Article 55 BPR)
  • The active substance is manufactured/imported for use exclusively in a biocidal product which is the subject of experiments or tests for the purposes of scientific or product and process-orientated research and development (Article 56 BPR).

If you manufacture or import a substance for biocidal and non-biocidal uses, you need to register it for the quantities of the substance used in non-biocidal products.

Which substances used in plant protection products are regarded as registered?

Active substances manufactured or imported for use in plant protection products, in accordance with Regulation (EC) No 1107/2009 concerning the placing of plant protection products on the market, are regarded as registered under REACH (for that use) if the active substance is approved and included in Commission Implementing Regulation (EU) No 540/2011 (list of approved active substances), or where the application for approval of the active substance is deemed admissible in accordance with Article 9 of Regulation (EC) No 1107/2009.

Amounts of the same active substance used for other uses than in plant protection products are not regarded as being registered even if they are approved. Also, other substances such as co-formulants, synergists, safeners and adjuvants are not regarded as being registered.

The Commission maintains an electronic list of the approved (and non-approved) active substances which is available at the following link:

http://ec.europa.eu/food/plant/pesticides/eu-pesticides-database/public/?event=activesubstance.selection&language=EN

When should a recovered substance be registered?

A recovered substance should be registered as soon as it is no longer considered waste (when it reaches the end of waste criteria).

For further information on the end of waste criteria, see the following page:

How do I document that a recovered substance is already registered?

To benefit from this exemption, you need to document that the following conditions apply:

  1. The same substance must have been registered.
  2. The substance must be the same.
  3. The company that did the recovery must have the information required by REACH available (e.g. safety data sheet).

For further information, see chapter 2.2.3.5 ‘Recovered substance already registered' in the Guidance on registration:

Which substances are covered by Annex IV?
Annex IV of REACH lists a number of substances for which sufficient information is available to consider them as causing minimum risk to human health and the environment.
 
These substances are typically of natural origin and the list of exempted substances includes, for example, water and nitrogen. Substances included in Annex IV are exempted from the registration provisions.
 
The registration exemption applies to the substance as such, not to a particular use.
 
For more information see Annex IV of the REACH Regulation:
 
How do I proceed if I have concerns about confidential business information (CBI) when discussing substance sameness?

Consider taking specific measures in the SIEF to protect information that you consider CBI, but you nevertheless need to share with the SIEF to conclude on the substance sameness. You can, for example:

  1. Have confidentiality agreements that limit access to documents or other information to specific named persons, or departments; and
  2. Allow access to certain documents in a ‘reading room’ only (where copying is not allowed); and
  3. Agree to have certain documents reviewed and/or assessed only by a third party expert (independent consultant) or a trustee.

You can strengthen this by having additional personal confidentiality agreements for those who get access to the CBI documents. 

As a minimum, you should specify to the other SIEF members that the information is indeed CBI and, therefore, you communicate it and it can be used only for purposes of the verification of substance identity under REACH.

For more information on CBI, see section 9 of the Guidance on Data-sharing (https://echa.europa.eu/guidance-documents/guidance-on-reach).

Why have I not received a registration number even though I submitted my registration dossier on time?

There can be a number of reasons for this. Have a look at the scenarios below.

If you submitted your registration on time, you can continue to manufacture or import your substance even if you have not yet received your registration number. You would need to cease manufacture or import only if ECHA rejects your registration.

Your dossier is considered as ‘submitted’ when it passes the business rules step. You are informed about it through your REACH-IT account and ECHA then assigns a submission number and a submission date to your dossier. The proof that you have submitted a registration dossier is this submission number and submission date that you have received in your submission report in REACH-IT. If you are a lead registrant, it is only after your lead registrant dossier has passed the business rules check that the member registrants can submit their own dossiers.

If your dossier has failed the business rules check, you have also been informed about it through your REACH-IT account. In this case, you have missed the legal deadline and are not entitled to manufacture, import or market the substance in the EU/EEA. You can only start manufacturing or importing again once you have submitted a complete registration dossier and received a registration number from ECHA. In the meantime, you may place on the market any stocks you might have (Reference: Q&A 40). Submit a registration dossier as a matter of urgency! Document your submission attempts so that you can demonstrate that you took corrective action as soon as you could.

Scenario 1: ECHA is still processing your dossier

ECHA has until the end of August 2018 to verify the completeness of the dossiers that were submitted in April and May 2018. Keep track of the progress through your REACH-IT account. In the meantime, you can continue manufacturing or importing your substance.

Scenario 2: You have not paid the registration fee

Your registration will only be complete once ECHA has confirmed that your registration includes all the required information and you have paid the fee indicated in the invoice you have received through your REACH-IT account.

If you do not pay by the initial payment deadline indicated in the invoice, you will automatically be granted an extension. However, if you do not pay by this extended deadline, ECHA will reject your registration. You will have to cease manufacturing or importing activities, as you can only legally manufacture, import or market your substance once you have successfully registered it. In the meantime, you may place on the market any stocks you might have (Reference: Q&A 40).

Scenario 3: Your dossier has failed the first technical completeness check

In this scenario, we will tell you what needs to be done and what the deadline is for submitting the missing information. You will have at least four months for this, so invest time in fixing the errors reported before resubmitting the full information as an update. You only have this one last chance to update your dossier so that it passes the technical completeness check. Make sure that you follow the instructions carefully and provide all the information requested, and only resubmit when you are sure you have addressed all failures.

Use the Validation assistant tool in IUCLID to avoid the risk of failing again – you will not get a third chance. If you still have questions, contact ECHA to make sure you understand what you need to do to complete your dossier.

Scenario 4:  Your dossier has been rejected as it has failed the technical completeness check a second time

You will have to start the registration process all over again and resubmit your dossier as an initial submission. Any fee that you paid in connection with your failed first registration will not be refunded.

You will have to stop manufacturing or importing activities, as you can only legally manufacture, import or market your substance if you have successfully registered it. In the meantime, you may place on the market any stocks you might have (Reference: Q&A 40).

What should I do if I did not submit my registration dossier by 31 May 2018 deadline?

31 May 2018 was the last chance to submit a registration for existing (phase-in) substances manufactured or imported in amounts of more than one tonne per year. If the registration obligation applied to you, but you did not submit your dossier by then, as of 1 June you can no longer manufacture or import your substance legally in the EU/EEA. You may, however, continue placing on the market any stock that was manufactured/imported before the deadline.

If you missed the deadline, you should make yourself compliant without delay:

  • If you have pre-registered or inquired about your phase-in substance, you can register it directly (until further notice, you can still use the pre-registration number).
  • If you have not pre-registered or inquired about your phase-in substance, you need to submit an inquiry before registering it.

If you submit your dossier after 31 May, you will need to wait until you receive your registration number before resuming or starting manufacture or import of your substance.

 

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