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REACH

Scope of REACH

Who is responsible for the enforcement of REACH?

Member States endorse national provisions defining controls and sanctions for non-compliance with REACH. We recommend you to contact the relevant enforcement authorities in your country for information on the national control procedures in place. You can also contact the customs authorities and the national helpdesk for further information.

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.

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.

 

To which territories does REACH apply?

REACH is an EU Regulation that directly applies in all Member States of the European Union. REACH is of EEA (European Economic Area) relevance as it has been incorporated into the Agreement on the European Economic Area. This means that REACH also applies in Iceland, Liechtenstein and Norway. 
Substances imported into the EEA from Switzerland (a non-EU country belonging to the European Free Trade Association but not to the EEA) are treated under REACH in the same way as substances imported from any other non-EEA country. 
The Member States are best placed to explain how REACH applies to their territories (autonomic areas or overseas territories). We therefore recommend contacting the national REACH helpdesk of the relevant country to clarify specific questions in this regard.

What are the REACH obligations of non-EEA companies?

Manufacturers established outside of the European Economic Area (EEA)/EU do not have direct obligations under REACH, as the EU importer needs to comply with the obligations. 

Non-EU companies exporting substances to the EU can (but are not obliged to) appoint an "only representative" to fulfil the obligations of importers. More guidance on only representatives can be found in our Q&A section on Only Representatives and in the Guidance on registration section 2.1.2.5- "Only representative of a non-EU manufacturer".

For further information, see also the webpage concerning the non-EU companies.

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.
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 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. 
Who is an importer and how to determine it?

An importer is any natural or legal person established within the Community who is responsible for import (Article 3(11) of the REACH Regulation). Import means the physical introduction into the customs territory of the Community (Article 3(10)).
The scope of the customs territory of the Community is defined in the relevant Community legislation on customs that should be consulted for further information. [Regulation (EU) No 952/2013 of the European Parliament and of the Council of 9 October 2013 laying down the Union Customs Code].
It is important to note, however, that the REACH Regulation and the Customs legislation are independent from each other.
The import of a substance on its own, in mixtures or in articles manufactured or produced outside the European Union is considered placing the substance, mixture or article on the Union market.
The responsibility for import depends on many factors such as who orders, who pays, who is dealing with the customs formalities, but 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 the Guidance on registration, chapter 2.1.2.4 "Who is responsible for registration in case of import?".

What is considered as manufacturing?

Under REACH, manufacturing means producing or extracting substances in their natural state. It is a case-by-case decision to establish the extent to which the different steps in producing the substance are covered by the definition ‘manufacturing'.

Example
A company that purchases registered substances from within the EU and then formulates these into mixtures (e.g. paints) would be regarded as a downstream user under REACH.

In layman's terms, this company might be considered to be a manufacturer of paints. However, within the context of REACH, the company would not be a manufacturer of a substance and so would have no registration obligations for these substances. For further information see the Guidance on registration. Examples on manufacturing of intermediates available in the Guidance on intermediates and Practical Guide 16.

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:

Which substances are covered by Annex V?

Annex V of REACH lists a series of broad  categories of substances for which registration is deemed inappropriate or unnecessary. Substances included in Annex V are also exempted from the supply chain communication and downstream user provisions, as well as evaluation.

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?

Where necessary, in the interests of defence, Member States may allow for exemptions from the REACH Regulation in specific cases for certain substances on their own, in a mixture or in an article (Article 2(3) of the REACH Regulation). 

Furthermore, Member States are not obliged to supply information the disclosure of which they consider to be contrary to the essential interests of its security (Article 346 TFEU1).

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

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 because of their intrinsic property.
 
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, supply chain communication and downstream user provisions as well as evaluation.
 
The registration exemption applies to the substance as such, not to a particular use.
 
For more information see Annex IV of the REACH Regulation

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