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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.

 

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. 

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