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As part of the breakthrough change, the court mentioned that 鈥渢he REACH Regulation鈥檚 definition of an 鈥渁rticle鈥�, taken together with the lack of any provisions specifically addressing the situation of a complex product containing several articles, means 鈥渢here is no need to draw a distinction between the situation of articles incorporated as a component of a complex product and that of articles.鈥�

The Advocate General, last year ( 18th February, 2015) had opined to ECJ that the 0.1% threshold should apply to each component separately and not to the whole article. Since the verdict has now been endorsed completely without any modifications by ECJ, REACH compliance will get stricter for companies selling products in the EU market. This would further result in increased compliance burden for manufacturers, importers and distributors differently, thereby ensuring that companies get their practices in line with the modified regulation.

ECJ鈥檚 decision comes in line with the views of the 5 EU member states and Norway (member of European Economic Area-EEA) but it contradicts the earlier view adopted by EC and ECHA.

As per REACH, when the article contains an SVHC in a concentration >0.1% then manufacturers should provide the information about the inclusion and safe use of the chemicals to the customers. Now after the ECJs ruling, the 0.1% threshold is no longer calculated on the basis of the whole article (former ECHA interpretation) but of 鈥渆ach of the articles incorporated as a component of a complex product.鈥�

This ruling will have a huge impact in the manufacturing industry as it increases the burden of REACH compliance in companies at a deeper and complex level. It will affect the way samples are analyzed (at the component level), the number of analysis to be conducted, and how they are reported under to become compliant.

There will also be a substantial impact on REACH documentation, since manufacturers of finished electronic products will need to have a REACH declaration for each individual component before the complete product could be declared. Some manufacturers may need hundreds of declarations from their suppliers so as to confirm their products as 鈥榥ot containing SVHC鈥�.

With respect to SVHC notification, EU producers and importers would have to notify listed SVHC鈥檚 above the threshold in each component (possibly including sub-assemblies) they produce/import and in the article as a whole. Suppliers or downstream users have to collect declarations from the producers for the products they supply (and each component the product contains, if required) and pass it to the customers.

A person supplying a product with one or more constituent articles containing an SVHC above the threshold will have to make sure that he receives all the required declarations for the article as a whole and for each component inside the article from the manufacturer.聽 So in fact the enquiries to manufacturing companies will increase in huge number as a result of this ruling of ECJ and the compliance burden would thereby drastically increase in the testing as well as documentation side for the manufacturers of finished electronic products.

For the future, lots of clarifications and guidance required from ECHA for manufacturers on how to handle the new changes in REACH and the guidelines needs to be modified by ECHA.

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SDS and its importance in REACH

REACH Regulation has been implemented by European Union to control the use of hazardous substances in the EU market for protecting human health and the environment. REACH obligates聽everyone in聽the supply chain to communicate freely about the substances they use, particularly with respect to substances that can cause any hazards to human health and the environment.聽REACH mandates this communication to occur through the supply chain both upstream and downstream.

To enable free flow of communication between suppliers and downstream users in all stages of the (SDS) are used. Since SDS is the vital component of GHS, they are intended to provide all necessary information about physical and chemical data of a substance/mixture for its safe use in any application. To maintain their products in the EU market, manufacturers, importers, distributors, and downstream users must make sure that their SDS for substances and mixtures comply with the requirements of REACH.

As per GHS, an SDS should be prepared for substances and mixtures which meet the criteria for physical, health or environmental hazards. SDS should also be prepared for all mixtures that contain carcinogenic, mutagenic or toxic to reproduction elements in concentrations exceeding the threshold limit specified for SDS.

In such cases of preparation of SDS, the following should be included:

• Information about the properties of the substance/ mixture
• Information on its hazards
• Instructions for transport
• Safety measures- instructions for safe use, disposal and exposure control

This information should be included in the main body of SDS or in the section for additional exposure scenarios.

In case there is a requirement to provide an SDS, it must be provided free of charge to anyone who has received or requested an SDS. SDS can be provided on paper or electronically. SDS should be provided either before or at the time of first delivery of the substance or mixture.

The SDS should be immediately updated if new information on hazards or risk management measures is made available. SDS must be updated as early as possible when:

• Any latest information on hazards becomes available
• Any latest information on risk management measures becomes available
• Details of authorizations granted or refused
• Details of any restrictions imposed

SDS issued after registration must also include the registration number.

With GHS alignment, each package of a classified hazardous chemical should be labeled or marked with the following elements:

• Product or chemical identifier that matches the product or chemical identifier on the SDS
• Contact information of the product or chemical supplier
• Hazard Pictograms
• Signal words
• Hazard statements
• Precautionary information

Transition of Material Safety Data Sheet (MSDS) to Safety Data Sheet (SDS)

Material safety data sheet (MSDS), which OSHA (Occupational Safety and Health Administration) calls a “one-stop resource for everything you might need or want to know about a chemical”, is the cornerstone of OSHA鈥檚 Hazard Communication Standard (HCS). OSHA revised the HCS to align with the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) to help manage the risks associated with chemicals in the workplace with the help of the new SDS. The intention behind GHS is to harmonize classification criteria and hazard communication tools at regional, national, and worldwide level. Due to this, OSHA adopted United Nations鈥� GHS and brought substantial changes to MSDS. This led to the formulation of SDS.OSHA further decided to standardize the 16 section format with a required ordering of sections for SDS as a mandate. Hence, REACH SDS now includes these rules that are in line with GHS to help manage the risks associated with chemicals. Annex II of the REACH Regulation provides the detailed requirements and format of SDS for substances and mixtures.

Over the past 3 years UN鈥檚 GHS format for SDS has received global acceptance, leading to implementation of GHS in the European Union and Asian manufacturing nations like Korea, China and Japan.

SDS was formerly named as MSDS (Material Safety Data Sheet) which was functionally equivalent to the new SDS with a slight format change in the template and content. Below mentioned are a few details about the transition of MSDS. GHS formatted SDS and ANSI Standard 16-section MSDS are nearly identical. One of the major changes is the 鈥榬enaming of material safety data sheets from MSDS to SDS.

The other major changes are:

1. As per GHS requirements SDS has a reclassified order for the standard 16 sections. The new order is mentioned below.

• Identification
• Hazard(s) Identification
• Composition/Ingredient Information
• First-Aid Measures
• Fire-Fighting Measures
• Accidental Release Measures
• Handling and Storage
• Exposure Control/Personal Protection
• Physical & Chemical Properties
• Stability & Reactivity
• Toxicological Information
• Ecological Information
• Disposal Considerations
• Transport Information
• Regulatory Information
• Other Information

An SDS needs all 16 sections completed in the above order to become GHS-compliant SDS.

2. SDS needs to represent the hazardous effects of the substance with the use of GHS standard pictograms
3. Inclusion of key words and phrases in the SDS, standardized by GHS
4. Introduction of new GHS labels
5. Need for conducting updated employee trainings

Important dates to remember :

Manufacturers need to keep track on the following dates to be able to execute successful for their products, in lines with the upgraded version of GHS-SDS.

• Employers must educate employees on the updated information by December 2013.
• Manufacturers must update all the MSDS to SDS by June 2015.
• Employers and end users must have the new GHS-compliant SDS in their workplace for their chemicals by June 2016.

By June 1, 2015, Chemical manufacturers and distributors are expected to complete their reclassification of chemicals and should start the shipping of GHS formatted SDS and labels with their delivery. MSDS database should be updated to GHS formatted SDS database within the same time period.

Conclusion

Despite no official confirmation from EU, manufacturers have some respite in case they share the SDS documents within 1^st June 2015. As per a reputed agency document EU will continue to allow the SDS (as per old standards) for the next 2 years, if the SDS was shared by the manufacturer before 1^st June 2015. This provides more time to the chemical manufacturers for sharing the GHS formatted SDS with their customers. But to avoid last minute filings and to obtain easy access to US, European and Asian markets its suggested to get the SDS refreshed as early as possible.

SDS will continue to be the backbone of hazard data communication irrespective of being called MSDS or SDS. Manufacturers who can foresee the future and take proactive implementation can make MSDS to SDS transition an easier job as the dead line approaches.

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