REACH and Biocidal Regulations explained……
REACH and Biocidal Regulations explained……
Chemicals and other potentially harmful substances and stringently regulated by the EU legislation in order to ensure that they are being used, safely and responsibly.
REACH (Regulation, Evaluation, Authorisation, and Restriction of Chemicals) and the BPR (Biocidal Products Regulations) are two of these pieces of regulations – and compliance with these regulations can be quite difficult for some small businesses – especially when you don’t have an informed distributor. Regulations are complex and some buisnesses really do struggle with both following and understanding the rules but also compliance with them.
So what implications does REACH have?
The REACH regulations came into force in June 2007, and is concerned with authorisation, restriction, and authorisation of chemicals. The REACH regulations are concerned with chemicals which are imported in to the EU in large quantities, although some substances are excluded, with many chemicals it changed the landscape of the chemical market forever.
The rollout of the REACH regulations have revolutionised some of the products lines we’ve had contact with over the years? Do any of you remember Black Disinfectant? The ingredients in this product were just deemed too harmful to allow it entrance in to the EU, so it was regulated as ‘not allowed entry’ which means that to actually get any Black Disinfectant in its original pure form is almost impossible today.
These regulations mean that all importers or manufacturers must register their substances with the European Chemicals Agency (EHCA) for them to be legally traded. How each company should comply with REACH depends on where they sit on the supply chain.
The HSE have directed that the responsibility of both employers and suppliers have not changed now that we have left the EU, and the laws and regulations previously laid out remain pertinent.
EU Biocidal Products Regulation
The EU Biocidal Products Regulation regulates biocides. Biocidal products are designed to mitigate the effects of harmful organisms or bacteria through chemical or biological means. These are mainly used to control bacteria, viruses, fungi, and insects. The BPR revolves around the requirement to be authorised before they can be sold, ensuring that all biocides are safe.
Both sets of regulations have been created and enforced across Europe by the European Chemicals Agency ECHA. ECHA is the driving force amongst regulatory authorities in implementing the chemicals legislation. It aims to benefit both human and environmental health providing a framework which is both sustainable and safe.
Compliance with both REACH and BPR is critical both in terms of making sure that your business is sustainable and staying in line with the EU laws. REACH presents several potential challenges, in that it requires companies to complete registration and authorisation processes for substances that meet just one of the following criteria.
- Listed in the European Inventory of Existing Commercial Chemical Substances
- Manufactured in the EU but have not been placed on the EU market after 1stJune 1992
- Qualify as ‘no-longer polymer’
BPR regulations present challenges that are much the same as REACH’s, as all biocidal products to be placed on the market must be authorised. The authorisation process involves putting together dossiers which include extensive data about the efficacy, physical chemistry, toxicology, and environmental impact of each biocide or family of biocides seeking authorisation.
If you’d like any advice on REACH or BPR, safety data sheets or anything else, give our office a call!
