Maintaining Confidentiality of Trade Secrets in REACH Safety Data Sheets

 

Anyone who sells chemicals deemed hazardous in the European Union must comply with the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) that came into effect from June 2007. In addition, they also have to content with Regulation 1272/2008 on Classification, Labeling and Packaging (CLP) of substances and mixtures according to UN GHS norms. This is effective from January 2009.

While both are tools to communicate hazards, there is an essential difference. CLP focuses on labeling and REACH specifies rules for the safety data sheets. REACH may apply to quantities above a specified limit whereas CLP applies regardless of quantities involved. REACH SDS registration is mandatory whereas CLP is not mandatory provided chemicals are REACH registered prior to November 2010. The situation can be complex and confusing. This is further compounded by the fact that REACH is more extensive as regards protection of human health and the environment. Chemicals must be categorized and described without any ambiguities in a lengthy process and documentation. REACH safety sheet by icsds.com takes care of all the complexities and makes it easy for manufacturers to do business in the EU without contravening any regulations.

 

It must be kept in mind that full disclosure is required in the process of registration to show a substance’s property and risks. If need be, the authorities may impose restrictions or ban the substance. Full disclosure can pose a problem for manufacturers of proprietary chemical formulations. ICSDS experts adopt a variety of ways to ensure full conformity with REACH regulations while protecting vital trade secrets. A variety of methods may be adopted such as indicating a range of concentration and use of generic names. It may be necessary to apply to EU CLP in order to gain permission to hide composition information. However, REACH SDS will delineate full hazards as may be relevant. This professional and fine-tuned approach by ICSDS protects vital trade secrets of customers without infringing any rules. If necessary, the European Chemicals Agency (ECHA) may be approached to protect confidentiality of proprietary formulations. Experts will make a suitable application along with suitable justifications to reinforce the request for confidentiality. There are procedures to be followed under Article 119(2) and suitable fees to be paid for each item, all of which are taken care of by ICSDS professionals.

ICSDS goes beyond providing SDS services. Their expertise and industry knowledge as well as familiarity with REACH and CLP puts them in a class apart when addressing specific issues such as those of confidentiality of trade secrets. Companies can meet obligations of compliance while being assured that their secrets remain theirs. Should there be any dispute or should a question arise, experts are always available at hand to take on the matter with appropriate authorities.  ICSDS has extensive experience of EU regulations and has served quite a few clients in the past, not only with REACH SDS but also their translation into local languages in addition to training and acting as local representative. ICSDS represents total service for chemical businesses wishing to do business in the EU.

Assure Total GHS Implementation for EU with Professional Assistance

Though the Globally Harmonized System aims at harmony and uniformity in the safe handling, storage and disposal of chemicals, implementation vary from one country to another since they are free to adopt any revision and adopt it in full or part and add further regulations as they may seem fit. This is exactly what countries of the European Union have done. In addition to opting for version 4 of GHS (the latest, 6^th, likely to be implemented in the near future), EU countries also follow EU REACH and CLP regulations. It is mandatory for any chemical company to submit documentation in compliance with their regulations. 

REACH places the burden of GHS implementation on companies to identify and manage risks. It is not only risks related to handling, processing, storage, use and transport but also the safety of downstream user, disposal and effect on environment that is taken into consideration in the EU through REACH. The strange thing about REACH is that an exporter from the US or any other country is not bound by the regulations but the importer in the EU is required to comply with the pre-registration or registration process. This, however, does not absolve exporters because importers will only do business if an exporter is REACH compliant. Also, if quantities involved are below 10 tonnes per annum, some clauses may not apply but for quantities above 1 tonne, it is mandatory. Still, however, regardless of quantities involved, if any manufacturer-exporter wishes to do business in the EU, he must comply with REACH and CLP and this calls for exhaustive and detailed documentation. Now, in addition to the safeguards for storage, use, handling and transport, documentation must also include measures for protection of human health and environment safety through safe disposal advice.  Documents must be in the language of the country to which chemicals are exported. The REACH compliant SDS must be translated in a way that avoids any ambiguity, calling for specialized knowledge of local languages and usages in the countries forming part of the EU. 

 

A company in the US may not have a specific importer-distributor in the EU who is willing to undertake the process. In this case, registration becomes difficult. However, hiring expert GHS implementation companies resolves the issue since they appoint a local representative to carry out the process. 

Why is it so important in the EU? The simple fact is that downstream users are forbidden from using any chemical unless it has an accompanying safety data sheet on use and disposal. Therefore, even if it is a simple cleaning agent or paint or solvent, the product must be REACH compliant and must have the documentation if it is to be sold and bought within the EU and the documentation must be in the local language. This seems a formidable barrier but it becomes easy when one has access to experienced professionals well aware of all REACH regulations and the capability to comply as well as translate documents.