The REACH regulation (EU 1907/2006) came into force in mid-2007 and has particular importance to all companies dealing with substances, mixtures and articles, especially companies in the chemical industry.
REACH stands for
- Evaluation and
- Authorisation (Authorisation and Restriction)
- of Chemicals
The guiding principle of this regulation is to improve the level of protection of human health and the environment from risks posed by chemicals.
The REACH regulation concerns registration, evaluation and authorisation.
The regulation requires a united approach by all parties involved (manufacturers, importers, users) in Europe. All parties are required to prepare relevant data on each individual substance.
A substance may only be used in the EU if these data have been compiled and safe handling measures have been detailed.
This leads to the key statement of the REACH Regulation in Article 5: „No data, no market“.
Responsibility for the safe use of chemicals and derived products lies with the industry. This applies to the use of an individual substance in the EU over the entire usage chain and throughout its entire life cycle.
Control of processes under REACH and management of data are regulated by the European Chemicals Agency (ECHA) in Helsinki.
The industry is the principle actor in the registration process.
Prior to use, the manufacturer or importer of a substance must determine all properties of the substance (physical-chemical, hazardous and environmentally hazardous properties) defined as relevant in the regulation. All available data are to be compiled or redetermined according to the requirement profile stipulated in the regulation. The evaluation gives rise to the necessary measures for safe handling with this substance. The information is to be developed in conjunction with all manufacturers/importers of the same substance and submitted in a single document as a registration dossier to the ECHA. Once a registration number has been allocated by EHCA, the registrant is then granted approval to manufacture or import the substance.
Owing to the immense complexity, the regulation for substances allows the registration process to be spread out over a period of time. This is dependent on the hazardous nature and the manufactured/imported quantity of the substance per registrant. By the 1st June 2018 at the latest, all manufacturers/importers must have registered their substances (over the threshold of 1 ton per year), provided the substances are not excluded from the registration requirements.
There are two separate evaluation processes: Dossier evaluation and substance evaluation. The principle players in the evaluation processes are the authorities.
The ECHA examines whether the submitted registration dossiers comply with the regulation requirements and, if necessary, request corrections or additions.
A list of substances is compiled based on the hazardous properties and/or which could pose a risk in the quantities used in Europe to human health or to the environment. After prioritisation within the list, each substance is transferred to a Member State of the Community for evaluation. The Member State examines whether all the available information for each substance is sufficient to ensure safe handling and, where appropriate, requests further defined information from the registrants.
If there are sufficient data for evaluation, the authorities give recommendations for further action. If the existing data permit safe use, no further action is called for. If the existing information indicates a handling risk exists, appropriate action is called for. Authorisation or restriction may also be proposed.
Following appropriate evaluation and prioritisation of the risk presented by the respective substances, the authorisation processes may either initialise a handling restriction or the substance may be initially added to the so-called candidate list for subsequent inclusion in the authorisation list. The authorisation list also includes the date until which the substance may still be freely used. Thereafter, use is only permitted with submitted and subsequently approved application for authorisation of users.
If a substance is subject to registration, it must be registered prior to use. On issuing the registration number, the registrant and subsequent users receive authorisation to manufacture/import the substance or for use in accordance with the "safe uses" documented during registration, under which the downstream user may use the substance safely. That is to say, with no harmful effect on human health or the environment.
In order to fulfil these roles and obligations, extensive communication is necessary along the entire length of the supply chain. First, the downstream user must report usage to the registrant so that he may devise the conditions for safe use in the registration dossier. Secondly, the conditions of use as defined in the registration dossier must be passed on to the downstream users.
During the preparation of the registration dossier, the registrant identifies the hazardous properties of the substance. The hazardous properties are documented according to the CLP Classification, Labelling and Packaging - Classification (EU 1272/2008) and labelled in accordance with the GHS systems, Global Harmonised System. Furthermore, the conditions of use for safe handling are defined. These and other (safety) relevant information are passed on to the respective downstream users via the standardised safety data sheet.
MSDSs are regularly or immediately updated as soon as new information on hazards becomes available.
If the downstream user finds his usage is not a safe usage as described in the MSDS, then the regulation gives several options. The desired use can be registered by the registrant or the user himself, provided that safe handling can be proven.
If based on its hazardous properties authorities identify a substance for authorisation, after appropriate evaluation, it is initially added to the so-called "Candidate List". It then gains the status as an SVHC (Substance of Very High Concern). Entry into the candidate list triggers an immediate obligation of information (in accordance with Article 7 paragraph 2 and Article 33) to the ECHA or the supply chain if concentration of a substance is > 0.1 % weight by weight.
LEVACO works under existing legislation as a matter of principle, including the REACH and CLP regulation.
LEVACO has designated a REACH officer for organising and tracking the requirements under REACH.
LEVACO has pre-registered all substances liable for registration and also the raw materials (e.g., when used as monomer), where necessary. In other respects, the raw materials are registered or pre-registered by the suppliers.
LEVACO only distributes products compliant with the REACH regulation.
LEVACO passes on the necessary hazardous and substance information on the materials contained in the products with the MSDS to the customers.
LEVACO regularly checks the updated SVHC candidate list published by the ECHA. If candidate substances are included in LEVACO products, customer information is immediately listed in the MSDS of the product.
The following links also include comprehensive information on the REACH regulation and its implementation: