Please see below for information on REACH, BPD and CLP legislation.
REACH is a European Union regulation concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals, which came into force in 2007 and is implemented in the UK by the REACH Enforcement Regulations 2008.
REACH was devised as a single system to replace a number of older separate European Directives. The main purposes of REACH are:
- to protect health of workers and the environment in regards to the use of hazardous chemicals
- to ensure chemical manufacturers are responsible for managing any risks
- to allow an integrated European system to help manage the free movement of chemicals throughout the EU.
The regulations apply to single substances and the initial steps towards compliance are being taken by prime chemical manufacturers.
Further information can be found on the HSE website here.
Bio Technics Ltd and their associated companies are fully aware of the EU REACH regulations and are fully committed to complying with all requirements of the legislation.
However, Bio Technics is not a prime manufacturer of chemicals but a formulator and blender of substances.
We have established links with our suppliers in order to confirm that all raw materials used by us are expected to be supported by REACH legislation.
At present, we do not use any raw materials which fall into the highest health and environment risk categories and, under REACH legislation, require early authorisation. We shall therefore continue to pass on existing information through Safety Data Sheets (SDS) as required as part of REACH.
We anticipate that some of our customers will require supply chain information in order to prepare themselves for REACH and we will cooperate fully with any request with the aim to distribute information, wherever possible.
Introduction of the BPR in Europe:
Recently biocidal regulations in the European Union have been undergoing considerable change. The below is intended to act as an overview of the current situation.
What is the BPR?
The BPR (Biocidal Product Regulation) under Regulation (EU) 528/2012 was introduced in 2012 to replace the previous biocidal monitoring system called the BPD (Biocidal Products Directive). The purpose of the BPR is to improve the free movement of biocidal products within the EU whilst ensuring a high level of protection to humans, animals and the wider environment.
The BPR requires that all biocidal products are approved at a National or Union level before being placed on the European market. The BPR has a list called Article 95 which details all known active biocidal substances from around the world and classifies them into specific product types/uses. Further information can be found on the HSE website, please click here.
What are the implications for our products?
Before Bio Technics places any biocidal product on the European Market, the active substances contained in that biocidal product must first be approved for the relevant product type and the product must then be authorised for this use.
Currently, all the active substances Bio Technics uses in its biocidal formulations are still being evaluated by the BPR. Bio Technics continually monitors this BPR process for updates and is in regular contact with all our suppliers about this process.
We cannot authorise any of our products under the new BPR system until all the active substances in the formulation have been approved. However, we will continue to keep customers updated on this as progress develops.
In the meantime, please be assured that any existing registrations under the old national registration systems remain valid during this transition period.
The active substance review process is a very large undertaking for the BPR and will take a number of years to complete. We estimate that the review of our active substances will not be completed until approximately 2019, at the earliest.
What happens after the active substances are reviewed?
Once the review process has been completed, Bio Technics intends to submit Biocidal Product Dossiers to support our products and begin the authorisation process. This authorisation process could take a further 2 to 3 years, with the earliest anticipated completion not happening until approximately 2021.
Implications for customers outside of the EU?
The BPR is only directly applicable to products made or sold within the European Union and as such does not have an impact to customers operating outside of this territory.
CLP, or the CLP Regulation, stands for Classification, Labelling and Packaging of substances and mixtures and refers to European Regulation (EC) No 1272/2008.
CLP adopts the United Nations’ Globally Harmonised System on the classification and labelling of chemicals (GHS) although, unlike the GHS which is a voluntary agreement, is legally binding legislation throughout the EU.
CLP came into force on 20 January 2009 for chemical manufacturers and for formulators and blenders on the 1st June 2015 - Bio Technics worked hard to ensure that we fully complied with CLP legislation well before this deadline.
The adoption of CLP requires changes to the Risk and Safety Phrases - now retitled as Hazard and Precautionary Statements - and pictorial ideograms, changing from orange square ideograms to red diamonds.
For further information on CLP, please refer to the HSE website here.
If you have any questions on CLP, BPD or REACH, please contact us or call on +44 (0) 1561 361515.