Synazo e.K. and it's predecessor, Chemiehandel Dr. Doerner, have collected a vast expertise on chemical regulation. We successfully supported European distributors of biocides in legal duties such as registration of products.
In 2008 Synazo has formed a new company, Synazo GmbH, as we want to share our expertise on chemical regulation and legal affairs with other chemical companies. Synazo GmbH also supports non-EU manufacturers, acting as their OR (only representative) under REACh.
More details are available on request (please use our contact button on top of page).
Chemicals and risk: safe and secure handling
REACH (Registration, Evaluation and Authorization of CHemicals) is fully supported by Synazo. Regulation EC 1907/2006 was created for reforming European chemicals legislation, governing the handling of all chemical substances in preparations and products, including the substances themselves, irrespective of any inherent hazardous properties.
REACH requires manufacturers and importers to be responsible for the documentation of and transparency on safety of their chemicals and provide all data required for evaluation. They must be able to demonstrate, at advanced level, that products supplied by them in combination with well defined uses are safe to handle and do not compromise health of workers, consumers or environment. Manufacturers/importers have to register substances manufactured or imported in quantities of more than one metric ton per year per manufacturer/importer. Information on the substances and their uses together with possible required documentation must be filed in electronic format with ECHA (European Chemicals Agency) seated in Helsinki. The complexicity of data to be provided for registration depends on the quantity, inherent hazardous properties and defined uses of the substance.
REACh: a key objective
The objective of REACh is that manufacturers/importers enable downstream users to handle supplied chemicals safely, and enable them to eliminate risk to human beings and/ or the environment. Rigid deadlines have been set for registering chemical substances already on the market through every manufactuer and importer. The REACH process had started with the pre-registration of these substances. Pre-registration for the whole chemical community was possible until, and ended with December 1, 2008.
Synazo has completed pre-registration of all it's substances in due time. The following deadlines apply for completion of full registration :
for all substances placed on the market in annual quantities of >
for CMR* substances in categories 1 and 2 from 1 ton per year
for substances harmful to the environment with an N rating (R50/53)** from 100 tons per year.
for substances in annual quantities of 100 to 1000 tons.
for substances in annual quantities of 1 to 100 tons.
Transparency on all risks requires bi-directional communication
The aim of REACH is to assure safe handling of products for all uses defined. This requires complex and iterative information exchange between all parties involved in the supply chain. Increased cooperation between manufacturers/importers, their customers, and finally end-users (if the substance is not consumed during synthesis) means greater transparency all over the supply chain.
While manufactures/importers have to supply data on inherent properties to downstream users, downstream users have to supply identified uses to their supplier. Only then a manufacturer/importer, in feedback with his customer/downstream user, identify best practice methods for safe handling.
REACH affects the complete industry
Only few chemical substances are exempted from being registered. Polymers, some natural products, pharmaceutical, biocidal and crop protection active ingredients, and radioactive substances are exempt. (Specific rules apply in the case of polymers. Except natural products, all other products are already well covered by othe legislation.)
Every party supplying chemical products isinvolved. This inccludes producer of customer products like shampoo or detergents as well.
ECHA (European Chemicals Agency) at Helsinki is responsible for evaluating a registration. It will assess which tests still need to be carried out using the information in the registration dossier.
* CMR: carcinogenic, mutagenic, reprotoxic
** N(R50/53): dangerous for the environment, very toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment