American manufacturers/dealers of hazardous
chemicals must comply with OSHA-GHS regulations for local processing and trade.
Exploring world markets, especially markets of the European Union, necessitates
compliance with Regulation EC No 1907/2006 (REACH) and Regulation 1272/2008
(CLP). There are differences to the SDS and compliances under these two
regulations. Compliance is necessary, especially when chemicals exceeding 10
tonnes in quantity per year are imported and distributed in the EU. It is a
requirement to provide extended safety data sheets known as eSDS also termed as
REACH SDS.
Sellers are obligated to supply REACH SDS at the
time of first delivery. The European Safety Data Sheets can
be in electronic or paper format. This is required when
the chemical is termed hazardous. Even if a mixture is not termed as dangerous
but if it contains chemicals that may be harmful to human health or to the
environment with a concentration of greater than 1%, then the SDS must be
supplied and must conform to norms. This applies to chemicals and mixtures that
are termed as persistent, bio accumulative and toxic materials or substances of
very high concern. REACH SDS may not be insisted upon if the chemical is not
hazardous but it facilitates trade.
REACH SDS has some changes. Section 1 requires
information on identification of chemical or mixture and the company. Section 2
deals with hazard identification. Section 3 covers composition and information
on ingredients. Section 7 covers handling and storage while section 8 deals
with exposure controls and personal protection. Section 11 and 12 pertain to
toxicological and ecological information. Section 15 relates to regulatory
information. SDS must be updated to REACH SDS for hazardous mixtures from
December 2015 and when a substance is classified according to CLP regulations.
The process is a bit complicated since it requires a manufacturer/exporter to
acquire a REACH registration number and follow various steps to include information
on exposure scenarios, derived no effect level and predicted no effect
concentration. The updated SDS is then called eSDS which may be in hundreds of
pages. Further, the document must be translated into the official language of
the member state where a manufacturer or exporter does business.
Given
these extensive requirements of REACH and CLP, a manufacturer would greatly
benefit from professional expertise in compilation of SDS to eSDS and then
translatation into the local language. This calls for extreme proficiency and
competence in SDS and label authoring services. The authoring service provider
must not only be competent about MSDS and SDS in the USA but must have equal
knowledge and expertise in EU norms besides possessing translation facilities.
Particular attention must be given to translation to ensure the meaning is not
lost in the process and this requires knowledge of local jargon and use of
standard phrases. This type of expertise may be availed from an established
service such as ICSDS that serves American and global clients. It also happens sometimes that American
exporters may have a manufacturing base in an Asian country and expert from
there to the EU and the US in which case their expertise in local and
international GHS compliances benefit such manufacturers.
