REACH Scope & exemptions

REACH Scope & Exemptions

Most chemicals are in scope of REACH. The lower threshold is 1 tonne per year.   Important exemptions exist.   Confusion about the exemption of polymers is notorious.   Under REACH ‘Articles’ (objects) have their own rules.

In scope or not in scope of REACH?

All substances that are manufactured, placed on the market or simply used in the EU are in scope of REACH. The substances may ‘substances on their own’, in mixtures or even as part of articles.   There are however a few groups of substances and activities to which REACH does not apply at all:
• Radioactive substances.   • Substances under customs supervision.   • Non-isolated intermediates.   • Transportation of dangerous substances.   • Waste.

REACH Exemptions

Several groups of substances are exempted from REACH. There are six main categories:   • Polymers - This sounds better than it is. Monomers and most additives are not exempted. See the section ‘Polymers and Monomers’ below.   • Substances completely exempted according to Annex IV - Some 90 substances that are well known and of low risk such as water, CO2 and numerous organic substances such as several fatty acids, vegetable oils, cellulose pulp etc.   • Groups of substances completely exempted according to Annex V. Some examples:   - Minerals, ores, ore concentrates, cement clinker, natural gas, LPG, crude oil, coal.   - H2 O2 N2, noble gasses etc.   - Substances resulting from a chemical reaction taking place when manufacturing an article.
• Substance used for R&D (PPORD)   • Substances exempted for certain uses   - Biocides and plant protection products.   - Medical products.   - Food, food additives and animal feed.   - Military purposes if so decided by a Member State.   • Substances recovered in the EU do not need to be registered again, if an ‘Extended Safety Data Sheets’ is available.     See the sections below for more information on:   • Polymers.   • Substances used for R&D.   Annexes IV and V and relevant guidance can be downloaded from our 'Glossary and Official Texts’ section.

Substances used for R&D (PPORD)

PPORD means ‘Substance manufactured in Product and Process Oriented Research and Development’. These substances are exempt from REACH Registration.   The exemption from registration applies to manufacturers and importers doing research, either by themselves or with listed customers.   The substances for these uses do not require registration, when they are not supplied to others in the supply chain for commercial purposes.
If a PPORD substance is used in a quantity over 1 tonne per use per year, the user must notify ECHA.   For details see the official ‘Guidance on Scientific Research and Product and Process Oriented Research and Development’, downloadable from the ECHA web site.

Polymers and Monomers

Polymers are exempted from REACH.   However: the monomers and most of the additives used for the production of the polymer must be registered if they are > 2% of the polymer weight. Even if they are no longer present as such.   The following additives are exempted from registration: unbound heat stabilisers, light stabilisers and anti-oxidants.   Other additives must be registered if used in excess of 1 tonne per year.   Some monomers are Carcinogenic. They have to be registered immediately, even if their quantity is well over 1 tonne per year.
Polymeric articles do not have to be registered. Plastic film is an article, but Polymers in the shape of flakes or a fluid are always considered a substance or mixture.   Warning: The issue of Polymers under REACH is complicated. For details use the ‘Guidance for monomers and polymers’, downloadable from the ECHA website.

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