Reach & CLP Regulation Impact on Small and Medium Enterprise

2010 is a key year for the registration and declaration of chemicals for both, the Regulation 1907/2006 (REACH), and the Regulation 1278/2008 (CLP).
Companies that must register by November 30, 2010, should begin the process as soon as possible; first of all should contact the SIEF for sharing data on substances.
The SIEF is a forum for exchanging information on substances; its main objective is to allow maximum data sharing, so avoiding unnecessary costs and unnecessary animal testing; another aspect is to keep in mind that the data to be transmitted for individual registration without data sharing in a SIEF may be consistent and very expensive!
Operational summary of the registration procedure
The registration process takes place using two I.T. tools, referred to as REACH - IT and IUCLID 5.2. In the ECHA (European Chemical Agency) website specific pages and frequently asked questions (FAQs) are available; each EU country also has a national REACH / CLP helpdesk and an ECHA helpdesk; furthermore, assistance is also provided by industry associations, including the Enterprise Europe Network and the Chambers of Commerce.
Once the company has complied with the obligation to register, and has adhered to a SIEF, must then submit a registration booklet to the European Chemicals Agency (ECHA) comprising one common part, prepared and presented together with other producers or importers of the same substance, and one additional individual part containing specific information from the company.
To prepare the registration booklet sharing data with other members of the same SIEF, within a forum for exchanging information on the substance object of the registration, each SIEF appoints a leader that carries a common booklet, and checks and follows the instructions or requests; some SIEF are organized in an association. We must consider that the SIEF bring together companies that register the same substance and may thus share its data; this reduces the cost of double animal testing.
Registration costs are represented by the registration fees to be paid depending on the tonnage of the substances and the size of the company; the registration data received from other SIEF members must also be paid, but only to the extent necessary to their needs, and when actually needed.
The downstream user, which has no registration requirements, has however the obligation to follow the advice of the supplier on the measures of risk control, as indicated in the safety data sheets and exposure scenarios; if the use is not included in the exposure scenario, the downstream users must contact their supplier, requesting that such use be included in the exposure scenario, or, alternatively, can prepare their own chemical safety report, and inform the supplier, that then issues new information on the dangers of the substance or preparation, or considers that the advice provided to risk management is not adequate.


LABELING OF PREPARATIONS USING THE CLP REGULATION
The supplier of a preparation is responsible for the proper classification, packaging and labeling according to the laws and rules of a Member State and to the criteria of the new regulation, even if multiple problems are still unanswered, as in the case of packages consisting of mono use soluble films; they do not meet the standard requirements of label information, if the soluble films are considered as normal packaging, because in this case a printed label is required.
Additional unanswered questions involve the labeling procedures relative to hazard symbols, called pictographs; based on the directives of the Standard UN GHS, one often comes to the conclusion that the label of a preparation, in particular, must contain a series of signs that, actually complicate the reading of the label, possibly creating some confusion. Should we, perhaps, create a policy based on prevalence of risk for the identification of these pictograms?
What are the obligations of formulators? They must provide their customers with information on hazards and conditions for safe use of their substance (including measures of risk management).

Practical case of application of Regulation No. 1272/2008 (CLP) IN DETERGENTS - EXAMPLE: SODIUM HYPOCHLORITE.
Before the entry into force of the CLP, preparations containing less than 25% hypochlorite were generally not classified. From tests on a solution of sodium hypochlorite on aquatic species (for acute toxicity on Daphnia Magna), the results obtained, combined with other available data, imply that the acute toxicity of the substance is in the range of10