This manual has been compiled since recent surveys and inspections showed that many SMEs are not
aware that the REACH and CLP Regulations have a direct impact on their business.
The general rules for the marketing of chemicals in the EU are set by:
- REACH (for Registration, Evaluation, Authorisation and Restriction of Chemicals)
- CLP (on classification, labeling and packaging of substances and mixtures)
- complemented by other, sector specific legislation, such as the Regulation on biocidal products (RBP).
These have implications for the activities of most companies in the European Economic Area (EEA), namely the EU Member States, Iceland, Liechtenstein and Norway.
SMEs have the same responsibilities as large companies and cannot be exempt from any of the requirements for chemical safety.
The REACH Regulation, in force since 1 June 2007, sets safety standards for all chemicals.
This is to protect human health and the environment against risks from chemical substances, while promoting the EU chemical industry competitiveness.
Businesses (manufacturers and importers) have to demonstrate how a substance, they put on the market, can be safely used and communicate their risk management measures to their customers.
If the risk can not be managed, authorities (ECHA) may restrict the use of substances or make compulsory prior authorization for the substance, or even ban certain hazardous substances if their risks are unmanageable.
REACH establishes procedures for collecting and assessing information on the properties and risks of substances that companies are manufacturing or importing. Companies need to register their substances and have to work together in this context with other companies who are registering the same substances.
The REACH regulation aims to encourage companies to review their range of chemicals and replace the most hazardous substances with safer alternatives.
The CLP Regulation is applicable as from 1 June 2015 for the classification, labeling and
packaging of chemical substances and mixtures. This regulation complements REACH.
This regulation will ensure that workers and consumers in the EU are clearly informed about the dangers of chemicals in the EU through the classification and labeling of chemicals.
Before placing chemicals on the market, manufacturers and importers must establish the potential risks, and suppliers are required to classify, label and package them correctly.
The dangers of chemicals are communicated through standard statements and pictograms on labels and safety data sheets.
The Biocidal Products Regulation (RBP) concerning the making available on the market and use of biocidal products, which are intended to protect humans, animals, materials or articles against harmful organisms such as parasites or bacteria, thanks to the action of active substances contained in the biocidal product. All biocidal products require authorization before they can be made available on the market and the active substances contained in the biocidal product must be approved with the exception of those under review.
4. The ECHA guide
The ECHA guide, who is very practical, contains among others the following:
- The substances that fall under the scope of the regulations and must comply;
- The actors who have to comply;
In this context, a distinction is made between the manufacturer, the importer, distributor and downstream user (any natural or legal person established in the EU, other than the manufacturer or the importer, who uses a substance, on its own or in a mixture, in the course of his industrial or professional activities. These are formulators, end-users, producers of articles, the refillers, re-importers, importers with an only representative, industrial users and business users).
- Procedures for registration, authorization, restriction and communication depending on the type of business;
- The requirements regarding the classification, labeling and packaging of chemicals;
- An easy (step-to-step) guide allowing companies to discover the requirements they have to apply;
- Legal incentives for going green;
- A list of pictograms and products to which they have to apply;
- A list of the types of biocides.
SMEs should be made aware that they have the same responsibilities as large companies and cannot be exempt from any of the requirements for chemical safety. The only SME specific provisions are to pay reduced fees and charges.
You can consult the ECHA guide by clicking here.