REACH Regulation Glossary

Intertek provides a glossary of important terms to help our customers understand the complex EU REACH Regulation (EC1907/2006).

A

Article
A product with a shape, surface or design that determines its function to a greater degree than its chemical composition.

C

Candidate List
The list of substances created by the ECHA that will be studied for their possible inclusion as Substances of Very High Concern (SVHCs). SVHCs will be subject to authorization under REACH.

Category 1 & 2 carcinogens (Cat 1 & 2)
Substances in these lists will be subject to authorization under REACH. IARC classification system that defines carcinogens as:

  1. definitely carcinogenic to humans
  2. probably or possibly carcinogenic to humans

Carcinogens, Mutagens, Reproductive Toxins (CMRs)
SVHCs which cause cancer, cause damage to genes or are considered reproductively-toxic (i.e. causes either a decrease in fertility or problems with the development of the fetus).

Chemical Safety Report (CSR)
A report based on the chemical safety assessment required for all substances registered in quantities of 10 tonnes or more per year.

Consortium
A group, usually formed by an industry group, for the purpose of sharing information and costs of REACH.

D

Distributor
Any natural or legal person within the EU (including retailers) who stores or places a substance, preparation or article on the market, for third parties.

Downstream User
Any natural or legal person within the EU (other than manufacturers or importers) who use a substance, either on its own or in a preparation, in their industrial or professional activities. Examples include processors, formulators and packagers. Distributors and consumers are not considered downstream users.

E

European Chemicals Agency (ECHA)
The agency responsible for management of the pre-registration and registration processes associated with REACH. ECHA is based in Helsinki, Finland. Visit: http://ec.europa.eu/echa/home_en.html

Extended Safety Data Sheet (eSDS)
An eSDS is required for dangerous or PBT/vPvB substances manufactured or imported at >10 tonnes per annum. They include more extensive hazard assessment information.

I

Importer
Any natural or legal person within the EU that is responsible for importing a product. This includes physically bringing products into the EU. Placing on the market is not required. A non-EU manufacturer can take on the responsibility of an importer by assigning an Only Representative.

Intentional release
A substance is intended to be released when:

  • The release is essential for the end use function of the article or when the article would not work efficiently without the release, Examples: release of perfume of potpourri, wet wipes
  • The release contributes to a secondary function or is an added value of the article which is not directly connected to the end use function. Example: perfumed eraser

M

Manufacturer

Any natural or legal person within the EU that manufactures a substance in the EU. This includes production or extraction of substances in the natural state A non-EU manufacturer can take on the responsibility of an importer by assigning an Only Representative.

N

Notification
The requirement to notify the Agency of SVHCs contained within articles produced or imported into the EU. 

O

Only Representative
An EU-based representative of a non-EU manufacturer. The Only Representative is appointed by the manufacturer to fulfill the needs of an importer in the EU and have similar responsibilities.

P

Persistent Bioaccumulative and Toxic Substances (PBT)
Substances that can build up in the food chain to levels which are harmful to humans and the environment.

Phase-in Substance
Existing substances that meet one of the following criteria:

  1. Substances listed on the European Inventory of Existing Commercial Chemical Substances (EINECS)
  2. Substances placed on the EU market that were considered polymers but, according to the 7th amendment (92/32/EEC) of the Dangerous Substance Directive (67/548/EEC), are no longer considered polymers. This includes substances that meet the criteria but are not currently on the No Longer Polymers (NLP) list.
  3. Substances manufactured in the EU but not placed on the market since 1992

Pre-registration
The first stage in registering existing, phase-in substances. Pre-registered phase-in substances have an extended grace period before registration is required.

Preparation
A mixture or solutions of two or more substances/chemicals, pigments and/or solvents.

R

REACH (Registration, Evaluation and Authorisation of Chemicals)
The EU regulation that places greater onus on manufacturers, importers and distributors of substances to provide safety data and manage hazards associated with their products.

Registration
REACH registration requires manufacturers and importers to generate data on the substances they manufacture or import, to use these data to assess the risks related to these substances and to develop and recommend appropriate risk management measures.

S

Safety Data Sheet (SDS)
A form containing essential physical, chemical, and health and safety data for a substance or preparation. These are also known as Material Safety Data Sheets (MSDS).

Substance
Individual chemical elements, or compounds in the natural state or obtained by any manufacturing process

Substances of Unknown or Variable composition, Complex reaction products or Biological materials (UVCB)These substances have additional identification requirements due to their unknown or variable composition. Identifiers such as source, manufacturing process and genetic code may be required to fully define the substance.

Substance Pre-registration Information Package (SPRIP)
A package that contains all required registrant information and substance identification for pre-registration. The package also contains molecular and compositional information (used mainly for multi-constituent substances and UVCBs).

Substance Information Exchange Forum (SIEF)
A mandatory forum created during pre-registration to assist the sharing and data collection of REACH compliance information and studies with other registrants of the same substance.

Substance of Very High Concern (SVHC)
Substances such as CMRs, PBTs, vPvBs and endocrine disruptors that are dangerous to human health and/or the environment and will be subject to authorization, notification and/or restriction under REACH. View the current SVHC Candidate List.

V

Very Persistent very Bioaccumulative substances (vPvB)
Substances that can quickly build up in the food chain to levels which are very harmful to humans and the environment.

 
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