Are your substances exempt from REACH?

There are two categories of exemptions: substances out of the scope of REACH � total exemptions � and substances exempt under certain articles of REACH �partial exemptions. Total exemptions of REACH

These substances are listed in article 2.1 of REACH. They are outside the scope of the regulation. They are:

• Radioactives substances (Directive 96/29/Euratom)
• Non-isolated intermediates and
• Transported hazardous substances (International regulation ADR/IATA/IMDG�)
• Waste (as established in Waste Framework Directive 2006/12/EC: light dossier to submit to ECHA)
• Substances under customs supervision, on their own or in mixtures or articles.
• Substances used in the interest of defense and covered by national exemptions
• Substances used in biocides and plant protection products are considered as already registered, as well as � new substances � or NONS (Notification of New Substances) � notified under the directive 67/548/EEC.

All other chemical substances placed on the European market in amounts higher than one ton a year are impacted by REACH. However, it can depend in some cases.

Partial exemptions of REACH

Substances subject to partial exemptions are either exempt from REACH registration and authorisation or only exempt from REACH registration. It is generally required to provide a lighter dossier than for a classic REACH registration to notify the exemptions to ECHA. EcoMundo provides the services you need.

1) Substances exempt from REACH registration and authorisation

Are exempt from REACH registration and authorisation:

• Substances used in research and development as defined in article 9. Exemption concerns scientific research and development (SR&D) and product and process orientated research and development (PPORD) activities. NB: For substances used in product and process orientated research and development (PPORD), you must submit a notification in dossier format. (Exempt for 5 years, renewable for 5 more years (drug development, renewable for 10 years)
• Substances used in food and feedstuffs as flavouring under article 2, paragraph 5 of REACH
• Substances used in medicinal products under article 2, paragraph 5 of REACH

2) Substances exempt from REACH registration

Are exempt from REACH registration:

• Natural substances, not chemically modified. Their risk is considered as sufficiently well known:
• Substances that present minimum risk because of their basic properties. These are substances for which we have sufficient information to say that they only present a minimal risk. They are listed in Annex IV of REACH: water for example.
• Substances occurring in nature where registration is deemed inappropriate or unnecessary. These are substances from Annex V:
• 1- Substances which result from a chemical reaction that occurs incidental to exposure of another substance or article to environmental factors such as air, moisture, microbial organisms or sunlight.
• 2- Substances which result from a chemical reaction that occurs incidental to storage of another substance, preparation or article.
• 3- Substances which result from a chemical reaction occurring upon end use of other substances, preparations or articles and which are not themselves manufactured, imported or placed on the market.
• 4- Substances which are not themselves manufactured, imported or placed on the market and which result from a chemical reaction that occurs when:
• a stabiliser, colorant, flavouring agent, antioxidant, filler, solvent, carrier, surfactant, plasticiser, corrosion inhibitor, antifoamer or defoamer, dispersant, precipitation inhibitor, desiccant, binder, emulsifier, de-emulsifier, dewatering agent, agglomerating agent, adhesion promoter, flow modifier, pH neutraliser, sequesterant, coagulant, flocculant, fire retardant, lubricant, chelating agent, or quality control reagent functions as intended; or
• a substance solely intended to provide a specific physicochemical characteristic functions as intended.
• 5- By-products, unless they are imported or placed on the market themselves.
• 6- Hydrates of a substance or hydrated ions, formed by association of a substance with water, provided that the substance has been registered by the manufacturer or importer using this exemption.
• 7- The following substances which occur in nature, if they are not chemically modified: Minerals, ores, ore concentrates, raw and processed natural gas, crude oil, coal.
• 8- Substances which occur in nature other than those listed under paragraph 7, if they are not chemically modified, unless they meet the criteria for classification as dangerous according to Regulation (EC) No 1272/2008 or unless they are persistent, bioaccumulative and toxic or very persistent and very bioaccumulative in accordance with the criteria set out in Annex XIII or unless 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).
• 9- The following substances obtained from natural sources, if they are not chemically modified, unless they meet the criteria for classification as dangerous according to Directive 67/548/EEC13 with the exception of those only classified as flammable [R10], as a skin irritant [R38] or as an eye irritant [R36] or unless they are persistent, bioaccumulative and toxic or very persistent and very bioaccumulative in accordance with the criteria set out in Annex XIII or unless 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): Vegetable fats, vegetable oils, vegetable waxes; animal fats, animal oils, animal waxes; fatty acids from C6 to C24 and their potassium, sodium, calcium and magnesium salts; glycerol.
• 10- The following substances if they are not chemically modified: Liquefied petroleum gas, natural gas condensate, process gases and components thereof, coke, cement clinker, magnesia.
• 11- The following substances unless they meet the criteria for classification as dangerous according to Directive 67/548/EEC18 and provided that they do not contain constituents meeting the criteria as dangerous in accordance with Directive 67/548/EEC present in concentrations above the lowest of the applicable concentration limits set out in Directive 1999/45/EC19 or concentration limit set out in Annex I to Directive 67/548/EEC, unless conclusive scientific experimental data show that these constituents are not available throughout the life-cycle of the substance and those data have been ascertained to be adequate and reliable: Glass, ceramic frits.
• 12- Compost and biogas
• 13- Hydrogen and oxygen
• Substances already registered, then exported from and re-imported into the EEA, by an actor in the supply chain under article 2, paragraph 8
• Substances already registered and recovered through a waste recovery process (dossier to submit to ECHA).
• Substances manufactured or imported under 1 tonne per year under article 5, paragraph 1.

Note: These substances are exempt from REACH registration but it can be necessary to notify them to ECHA (see details below).

What must I do according to the different types of exempt substance?

_ If your substances are outside of the scope of REACH, no need to notify the ECHA ! Refer to the proper regulations.

_ If your substances are exempted from Registration and/or Authorisation, you may still have to notify the ECHA and provide a lighter version the dossier that contains some data of the SDS, but also analytical data.To make your job easier, EcoMundo takes care of all the entire process.

Below, what must be done for each type of exempt substance:

• For substances used in product and process orientated research and development (PPORD): you must provide a notification dossier created via IUCLID 6 such as: � PPORD under REACH regulation�. With this dossier, your substances will be exempt from registration for 5 years. You can then renew this exemption for 5 more years.
• For substances used in food and feedstuffs (Regulation (EC) No 178/2002) (including those used as additives, as flavouring) and medicinal products for human use (Directive 2001/83/EC) and veterinary use (Regulation (EC) No 726/2004, Directive 2001/82/EC), no notification required.
• For substances listed in annexes IV and V (partial exemptions), no notification is required: these substances are considered as sufficiently well known and as causing minimum risk because of their intrinsic properties or that registration is not necessary according to REACH. No notification is required for these substances, however, for substances exempt according to annex V, it�s recommended to have the documents justifying the exemption available (SDS proving the non classification, certificate proving a natural source �)
• For re-imported substances or for downstream users: you must ensure that the substances are already registered, otherwise you cannot use these substances on the European market.
• For substances recovered through a waste recovery process, REACH does not apply to waste under the directive 2006/12/EC. However, the waste step is taken into account for the life cycle assessment in the registration dossier. Beware! If you wish to benefit from exemption through the waste recovery process of a substance, the following two criteria must be met:
• The same substance must have already been registered during the manufacturing and/or importing step
• The recovered substance must be the same chemically as the one already registered. Identity criteria of the substances are defined in the Guide for the identification and designation of substances within REACH and CLP (ECHA website)
• If these two conditions are not met, then the recovered substance is subject to REACH registration.

Specific cases: polymers

Polymers are considered as of little concern as they have a significant average molecular weight. This is why they are exempt from REACH registration. Note that a polymers is defined in REACH according to the definition in article 3, paragraph 5 :
�polymer means a substance consisting of molecules characterised by the sequence of one or more types of monomer units. Such molecules must be distributed over a range of molecular weights wherein differences in the molecular weight are primarily attributable to differences in the number of monomer units. A polymer comprises the following:

• a simple weight majority of molecules containing at least three monomer units which are covalently bound to at least one other monomer unit or other reactant;
• less than a simple weight majority of molecules of the same molecular weight.�
• To add more detail to this definition, ECHA�s guidance on polymers indicates that over 50 percent of the weight for that substance must consist of polymer molecules and that the amount of polymer molecules presenting the same molecular weight must be less than 50 weight percent of the substance. Note that polymers are not all considered as polymers under REACH.
• If the substance considered is a polymer under REACH, then it is exempt from registration. However, monomers as well as additives used in the formulation (except those required to preserve the stability) must be registered.
• For monomers: Any manufacturer or importer of a monomer, for a use as a monomer and as a non-monomeric intermediate, a �standard� registration dossier is required to be submitted. Monomers are by definition intermediates and therefore, they cannot be subject to authorisation under REACH for such use as monomers in polymerisation reactions. Nonetheless, the specific provisions for the registration of intermediates under REACH do not apply to monomers. � The manufacturer or importer of a monomer substance has otherwise the same obligations under REACH as for any standard substance: general rules on restriction, information down the supply chain and classification and labelling therefore apply.�
• Check our REACH registration services for 2018
• EcoMundo is an expert service provider for REACH registration 2018 Our services include:
• REACH compliance Service
• REACH consulting Service
• REACH for non-EU manufacturer
• REACH Registration
• Only Representative (OR) service
• REACH Late pre-registration and inquiry process
• Representation of your interests within the SIEF and/or consortium.
• Negotiation on your behalf and purchase of the Letter of Access (LoA) from the Lead Registrant
• REACH letter of access
• Data exchange and drafting of your REACH IUCLID dossier.
• Submission of your REACH dossier to ECHA and follow-up until acceptance
• Delivery of your REACH certificate
• Regulatory watch when needed