REACH is future European regulation aiming at strengthening safety relative to chemicals - for human health and the environment. REACH stands for
|R||- for pre registration and registration|
The first step was pre registration of existing substances , where individual raw materials made or imported into Europe had to be pre registered by the 30th of November 2008. This allows substances to be subject to one of three phase in registration deadlines based on volume and hazards. The phase in deadlines are as follows
|CMR'S CAT 1 &2 (>1TPA)||- before 1st Dec 2010|
|R50/53 >100tpa ||- before 1st Dec 2010|
|>1000tpa ||- before 1st Dec 2010|
|>100tpa ||- before 1st June 2013|
|>1tpa ||- before 1st June 2018|
After pre registration , manufacturers and importers will form Substance Information Exchange Fora (SIEFS) for each substance to enable existing testing information to be pooled thereby removing the need for registrants to repeat any tests like animal tests that have already been performed. The costs of any new tests that have to be performed will be shared between SIEF members. The gathering of all this information will enable the registrant to prepare registration dossiers for submission to ECHA before the relevant phase in deadline. These will be evaluated to ensure each substance is safe to use from both a human and environmental perspective and if potential issues arise then their use will be restricted in those specific areas.
This is the " Global Harmonised System " and is aimed at classifying and labelling chemicals. The REACH and GHS regulations will therefore be closely linked.
GHS addresses classification of chemicals by types of hazard and proposes harmonised hazard communication elements , including labels and safety data sheets. It aims at ensuring that information on physical hazards and toxicity from chemicals be available in order to enhance the protection of human health and the environment during the handling, transport and use of these chemicals. The GHS also provides a basis for harmonisation of rules and regulations on chemicals at national, regional and worldwide level, an important factor also for trade facilitation.
The BPD stands for the Biocidal Products Directive , and the directive has three main objectives
- to harmonise the European market for biocidal products and their active substances such that product authorisation in one member state can be recognised in other member states
- to provide a high level of protection for people , animals and the environment ( from the use of biocidal products) through risk assessment. This requires the submission and evaluation of data relating to substances' chemistry, toxicity to humans and toxicity and fate in the environment.
- to ensure products are sufficiently effective against target species
This not only applies to suppliers of the biocidal product although they will produce the initial biocidal product dossier but also the manufacturers of the final product..
To be registered for the BPD , the biocide manufacturers have to produce a dossier of all hazards associated with the chemical so its effects are clearly understood.The dossiers need to be submitted depending on the final application of which there are 23 types split into 4 groups.
Once the biocidal product has been evaluated and assessed then the manufacturer of the final product needs to assess their end formulation as part of the BPD.