Regulations
WHAT IS EU REACH?
EU REACH is a new European Union regulation concerning the registration, evaluation, authorisation and restriction of chemicals. It came into force on 1st June 2007 and replaces a number of European Directives and Regulations with a single system.
AIMS
EU REACH has several aims:
- To provide a high level of protection of human health and the environment from the use of chemicals.
- To make the people who place chemicals on the market (manufacturers and importers responsible for understanding and managing the risks associated with their use.)
- To allow the free movement of substances on the EU market.
- To enhance innovation in and the competitiveness of the EU chemicals industry.
- To promote the use of alternative methods for the assessment of the hazardous properties of substances e.g. quantitative structure-activity relationships (QSAR) and read across.
SCOPE AND EXEMPTIONS
EU REACH applies to substances manufactured or imported into the EU in quantities of 1 tonne per year or more. Generally, it applies to all individual chemical substances on their own, in preparations or in articles (if the substance is intended to be released during normal and reasonably foreseeable conditions of use from an article).
Some substances are specifically excluded:
- Radioactive substances
- Substances under customs supervision
- The transport of substances
- Non-isolated intermediates
- Waste
- Some naturally occurring low-hazard substances
Some substances, covered by more specific legislation, have tailored provisions, including:
- Human and veterinary medicines
- Food and foodstuff additives
- Plant protection products and biocides
Other substances have tailored provisions within the REACH legislation, as long they are used in specified conditions:
- Isolated intermediates
- Substances used for research and development
Authorisation and Restriction in REACH
One of the main reasons of EU REACH Regulation, which is gathering most chemical legislation under an umbrella, is to protect environment and human health from the risks and hazards coming from chemicals. For this aim, procedures like registration has established to find more information on chemicals; and like notification/authorisations and restrictions to minimize or avoid the exposure of the hazardous substances to human and environment.
REACH Regulation brings different provisions for the substances have serious and often irreversible effects on humans and environment (Substances of Very High Concern-SVHC). The manufacturing, trading or using these substances which are carsinogenic, mutagenic, toxic, persistent and/or bioaccumulative can be controlled or limited or may subject to authorisation.
Substances that are included in the Candidate List by ECHA have been identified as Substances of Very High Concern (SVHC). The inclusion of a substance in the list may have legal obligations on companies and those substances may subject to Authorisations by decision of the European Commission if they include to the Annex XIV of REACH.
(Follow the links to find out more about the related procedure)
Authorisation = REACH Regulation Annex XIV
Restrictions = REACH Regulation Annex XVII
Sources:
Authorisation - https://echa.europa.eu/substances-of-very-high-concern-identification-explained
Restriction - https://echa.europa.eu/regulations/reach/restriction
What is the role of Elastron in REACH?
On ECHA's web page it says: "Companies that are not established in the EU have no obligations under REACH and cannot pre-register and register. However, a non-EU manufacturer of substances, preparations or articles whose products are imported into the EU can appoint an Only Representative. The Only Representative will then carry out the REACH obligations including pre-registration linked to the imported substances."
The company Pulver Kimya International GmbH has been appointed as "Only Representative" to provide information to customers and distributors about the EU REACH regulation issues by Elastron Kimya. The ‘Only Representative' notification has been shared with our EU customers. Pulver Kimya International GmbH will take place in supply chain and provide connection between our European customers and ECHA (European Chemicals Agency). Please click only-representative-letter.pdf for related letter (Only Representative Pulver Kimya International GmbH). Pre-registration of our substances to ECHA has been fulfilled.
List Of Substances of Very High Concern (SVHC) = Candidate List
In the context of REACH, substances of very high concern (SVHC) are:
- Carcinogenic, Mutagenic or toxic to Reproduction (CMR) classified in category 1 or 2
- Persistent, Bioaccumulative and Toxic (PBT) or very Persistent and very Bioaccumulative (vPvB) according to the criteria in Annex XIII of the REACH Regulation,
- identified, on a case-by-case basis, from scientific evidence as causing probable serious effects to humans or the environment of an equivalent level of concern as those above e.g. endocrine disrupters
* European Chemicals Agency published their first list of substances of very high concern (SVHC) on 28th of October 2008. After this date, the list is updated at different times. You can reach the updated list from this link: https://echa.europa.eu/candidate-list-table.
What is Elastron’s role in REACH?
ELASTRON KİMYA A.Ş. will inform customers and distributors about SVHC by their requests. For a sample of notification request, please click svhc-substance-information-sample.pdf
CLP
WHAT IS CLP?
C= Classification
L= Labelling
P= Packaging
It is the acronym for the new European Regulation (EC) No 1272/2008 on Classification, Labelling and Packaging of chemical substances and mixtures.
CLP Regulation (came into force on 20 January 2009) aims to apply United Nation's (UN's) Globally Harmonized System (GHS) criteria.
For United Nation's detailed GHS information.
Link: https://www.unece.org/
Notification to C&L; Inventory
According to the CLP Regulation, every manufacturer/importer is required to notify required substances (REACH - registrable or substance with hazardous) to the European Chemical Agency.
Pulver Kimya International GmbH has initiated a group to make notifications about the materials mentioned in REACH. Notification of all substances supplied by Elastron Kimya A.Ş. to EU importers was completed successfully before the deadline, 3rd of January 2011.
Useful links:
- Reach Regulation https://echa.europa.eu
- ECHA (European Chemicals Agency Official Web Site) https://echa.europa.eu/