Compliance and safety for the supply of chemical products
SAFETY DATA SHEETS
Safety Data Sheet Services
Alchemy Compliance has extensive experience in authoring EU compliant safety data sheets (SDSs). The service includes checking the classification of ingredients, against mandatory classifications in Annex VI of the Classification, Labelling and Packaging Regulation (CLP Regulation; 1272/2008), and against available information for other ingredients. SDSs are compiled with reference not only to legislation but also guidance documents such as the ECHA Guidance on the Compilation of Safety Data Sheets.
Manufacturers, distributors, and importers of dangerous substances are obliged to make themselves aware of the relevant and accessible data concerning the properties their products. Alchemy Compliance can fulfil this obligation on your behalf, through literature searching and structure–activity relationships.
SDSs can also be tailored for individual EU Member States (MS), including specific MS information such as the German WGK classifications and MAK values, and be translated into national languages.
Alchemy Compliance also offers authoring services for US, Canada, Switzerland, and Australia, in compliance not only with legislative requirements, but also with current guidance and best practices. SDSs for other territories, for example using the international United Nations Globally Harmonised System (GHS) format for SDSs, are available on request.
SDSs can be provided in your designated format, or supplied on our template.
Further information
Hazard communication and safety data sheets
Hazard communication deals with hazard data, not risk, and so a company uses the safety data sheet (SDS) supplied with a dangerous substance to perform an evaluation of risk in the workplace (eg under the UK COSHH Regulations; or the EU Chemical Agents Directive 98/24/EC).
Hazard communication, in the form of the SDS, is a central part of the REACH Regulation (1907/2006, Annex II; as amended by Regulation 435/2010), while the CLP Regulation (1272/2008) describes how substances and mixtures should be classified for their intrinsic hazards, and the requirements for labels and packaging.
The format requirements for the SDS given in the REACH Regulation (1907/2006), are more in line with the international format prescribed by the UN, ie the Globally Harmonised System (GHS).
It is the responsibility of all suppliers to ensure that dangerous substances are classified, packaged and labelled in the manner set out in the CLP Regulation. For mixtures, we are still in the transition period from the older Dangerous Preparations Directive (DPD, 99/45/EC; enacted as the CHIP Regulation in the UK) to the newer requirement of the CLP Regulation, so that classification according to either system is allowed. After 1 June 2015, mixtures must also be classified according to the CLP Regulation. The supplier should provide an SDS to his customer in the following circumstance (see REACH, Article 31): .
-
substances or mixtures classified as hazardous according to the CLP Regulation or the DPD (for mixtures), or in the new REACH categories of persistent, bioaccumulative, and toxic (PBT), or very persistent and very bioaccumulative (vPvB)
-
when requested by a professional user, for mixtures not classified as dangerous but containing >1% w/w of a dangerous substance (>0.2% v/v for gaseous preparations), or a substance with a EU workplace exposure limit (the level of detail on the safety data sheet may be lower than that for classified preparations, but should be sufficient to ensure a safe use by the recipient).
In all cases, the supplier of an SDS has the responsibility for its contents, even though they may not have prepared the SDS themselves. The duty is not absolute, but the supplier must exercise due diligence and be able to show that they have taken reasonable measures to ensure the accuracy of the information in the SDS. According to the Regulations, the SDS should be prepared by a competent person.
Safety Data Sheets are designed to allow the employer to protect workers and the environment by providing information under 16 headings:
Section 1: Identification of the substance/mixture and of the company/undertaking
Section 2: Hazards identification
Section 3: Composition/information on ingredients
Section 4: First aid measures
Section 5: Firefighting measures
Section 6: Accidental release measures
Section 7: Handling and storage
Section 8: Exposure controls/personal protection
Section 9: Physical and chemical properties
Section 10: Stability and reactivity
Section 11: Toxicological information
Section 12: Ecological information
Section 13: Disposal considerations
Section 14: Transport information
Section 15: Regulatory information
Section 16: Other information
Exposure scenarios and the extended SDS (ext-SDS)
The biggest change to the SDS under REACH is the requirement for an Annex containing the exposure scenario(s) (ES) derived from the chemical safety report (CSR), to give the so-called extended SDS (ext-SDS). An ext-SDS is therefore required only for >10 t and PBT/vPvB substances. Thus, REACH Regulation, Article 31.7 states:
‘any actor in the supply chain who is required to prepare a CSR (Articles 14 for M/Is or 37 for DUs) shall place the relevant exposure scenarios (including the use and exposure categories where appropriate) in an annex to the SDS covering identified uses…’
Development of exposure scenarios
So what is an ES? Annex 1 of REACH states:
‘An ES is the set of conditions that describe how the substance is manufactured or used during its life-cycle and how the manufacturer/importer (M/I) controls, or recommends downstream users (DUs) to control exposures of humans and the environment. These sets of conditions contain a description of both the risk management measures (RMMs) and operational conditions (OCs) which the manufacturer or importer has implemented or recommends to be implemented by downstream users.’
ESs cover any manufacture in the European Community and all identified uses. The assessor develops an initial ES, which is tested through risk assessment in an iterative process, which leads to a final ES (see diagram: Chemical Safety Asessment Under REACH); that is attached as an Annex to the SDS.
The ES includes a description of:
- Use
- Operational conditions:
- Processes, including the physical form of substance
- Activities of workers and consumers, and their duration and frequency of exposure
- Duration and frequency of emissions to the environment, and the dilution in receiving compartment
- Risk management measures:
- RMMs to reduce exposure to the substance of humans, and the environmental compartments (including waste management).Enhancement of the competitiveness of the EU chemicals industry
The large number of tasks to be described in the ES presents a problem, in terms of both definition of terminology, and the DUs ability to identify if their control measures are sufficient. For purposes of clarity, a simple task descriptor has been generated for each operational condition and RMM. An inventory of such descriptors available in the REACH guidance document, Guidance on Information Requirements and Chemical Safety Assessment, Part D Exposure Scenario Building, available at the ECHA website.
Such descriptors also allow automatic production of the ES through SDS authoring software. Also, instead of specific ESs, assessors may develop use and exposure categories. These are generic descriptions of operational conditions and RMMs which cover multiple uses, and may also help in protecting proprietary information.
Despite these provisions, the ES Annex to the SDS could prove enormously bureaucratic, and there are instances of the SDS Annex running to hundreds of pages. DUs may be faced with multiple ESs attached to a single SDS, and have to decide their relevance to using a particular substance or mixture in a particular way in the workplace. It is likely that many DUs, particularly small and medium enterprises, will lack the expertise to make such judgements. The Commission have commented in the SDS guidance: ‘The ES probably represents the greatest challenge for the ext-SDS in terms of presenting the essential information in a comprehensible format.’
Copyright Alchemy Compliance DISCLAIMER
FOR MORE INFORMATION PLEASE EMAIL: INFO@ALCHEMYCOMPLIANCE.COM