Chemical Testing according REACH
What is REACH?
The REACH regulation (EC No. 1907/2006) regulates the Registration, Evaluation, Authorization of Chemicals in the European Union and came into force on June 1, 2007. The competent authority is ECHA (European Chemicals Agency) in Helsinki, Finland. àlink
What Chemicals does REACH apply to?
REACH applies to substances that are produced or imported into the EU in a total quantity of 1 t / a or more. The definition of a substance comprises the following chemicals:
- Mono-constituent substances
- Multi-constituent substances
- Reaction Masses: Substances that consist of several components and have resulted from the reaction of two substances.
- UVCBs: Unknown or Variable composition, Complex reaction products or Biological material
Special requirements apply to Nanomaterials and substances that contain Nanoparticles.
REACH does not affect polymers (but their monomers), non-isolated intermediates, radioactive substances, pharmaceuticals, substances in transit or in product development.
What is required for a REACH Registration?
The scope of a REACH registration dossier for a chemical depends on the annual production and import volume of the substance. Standard data requirements are described in Annexes VII-X of the REACH regulation depending on manufactured and/or imported quantity (in t/a: tons per year):
- Annex VII for ≥ 1 t/a
- Annex VIII for ≥ 10 t/a
- Annex IX for ≥ 100 t/a
- Annex X for ≥ 1000 t/a
LAUS offers the complete set of studies for registrations in Europe according to REACH, and also according to the national regulations in countries outside the EU:
- Sameness / Substanz Identity Profile
- Physico-chemical Properties
- In vitro / in vivo Toxicology
- Mutagenicity / Genotoxicity
- Aquatic and terrestrial Ecotoxicology
- Environmental Fate (E-fate)
- Studies regarding Endocrine Properties
- Analytical Chemistry
All data and experimental endpoints must be submitted to ECHA in a technical dossier using IUCLID 6 software.
What is a Substance Identity Profile/Sameness?
The Substance Identity Profile (SIP) unequivocally describes a substance using appropriate spectroscopic and analytical methods. Each substance can only be registered once under REACH, the OSOR principle (One Substance - One Registration) applies. This means all registrants whose substances are covered by the same SIP need to collect the necessary data only once.
LAUS offers to put together a package with all relevant analyzes in order to clearly identify your substance. You will receive a report for submission at ECHA. The following methods are available:
- UV/VIS at 3 pH-values
- 1H-NMR/13C-NMR/solid NMR
- Mass spectroscopy: GC/MS with Headspace or LC-MS
- Water content (gravimetric, Karl Fischer, freeze drying)
- Specific methods for the characterization of Nanomaterials LINK
Using this procedure, the substances can also be clearly assigned to CAS or EN numbers.
The Substance Information Exchange Forum (SIEF) allows sharing of the collected data for joint registration, saving costs and time in a consortium, and avoiding unnecessary animal experiments (3R principle: Replace, Reduce and Refine). It is possible to join the SIEF later by means of a "Letter of Access" (LoA). Using a Third Party Representative allows to remain anonymous to other manufacturers, importers or downstream users.
How can LAUS support you?
There are four scenarios where new experimental endpoints may be required:
- If you want to introduce a new substance to the market, you have to register it.
- If the production volume increases and will exceed the volume band of the registration, the requirements of the higher volume band must be taken into account.
- If the Intended Use associated with the registration changes, then the data spectrum must also be adapted according to the new requirements.
- If ECHA evaluates the data situation as “irrelevant, not reliable (Klimisch Code 3 or 4) or not sufficient”, supplementary data will be requested.
LAUS offers to develop a specific approach according to your needs, based on the test item properties and the data requirements. Please don’t hesitate to contact us to discuss the test strategy or request a proposal.
Who is affected by REACH?
REACH relies on the responsibility of the chemical industry. Within the scope of REACH, every manufacturer, importer and downstream user of chemicals must ensure that these are registered accordingly before placing them on the market ("No Data, No Market" principle).
Non-EU manufacturers can appoint an Only Representative (OR) in the EU to register their substances or leave that duty to the importer.
REACH in non-EU Countries
More and more countries are amending their chemical legislation towards global harmonization. In many cases the principles of REACH are being adapted to national needs. These countries include:
- China: The MEP Order No. 7 (Measures on Environmental Administration of New Chemical Substance) came into force on October 15, 2010 and due to its similarity to the European model it is referred to as China REACH. On January 1, 2021 this was replaced by the Chinese Ministry of Ecology and Environment with MEE Order No.12 (Measures for the Environmental Management Registration of New Chemical Substances).
- South-Korea: AREC ("Act on the Registration and Evaluation of Chemical Substances") has been in force since January 1, 2015, and the revised version since January 1, 2019. This is also referred to as K-REACH.
- Turkey: KKDIK (also Turkey REACH) became effective on December 23, 2017, pre-registrations must be made by December 31, 2020.
- United Kingdom: The UK left the EU on 31 January 2020 (Brexit). The new UK chemicals regulatory framework, UK REACH, came into force on 1 January 2021. The Health and Safety Executive (HSE), will act as the UK Agency.
LAUS can act as your Only Representative (OR) in the UK after Brexit.
For more information about transition periods and information requirements, please click here.
In these countries mostly the same guidelines for experimental data apply. Our studies can also be adapted to national and individual requirements.
REACH was implemented in a phased approach, depending on the production volume and the previous status of the substances.
A distinction was made between non-phase-in substances that had to be newly registered, and phase-in substances that were already on the market and a transition phase was applicable.
Registration deadlines for phase-in substances:
- Volume ≥ 1000 t/a: September 2010
- Volume 100 – 1000 t/a: May 2013
- Volume 1 – 100 t/a: May 2018