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European Safety Data Sheet preparation for Fragrances, Flavours and Essential Oils

European Legislation requires that Safety Data Sheets are supplied for any hazardous product (ingredient or formulation). In many cases, customers also request a SDS when a product is not hazardous.The key is to determine if a product is hazardous!

For ingredients this is often straight forward as the quality and widely accepted safety information is available to members of industry associations through the IFRA / IOFI Labelling manual.

Many aspects of Fragrance and Flavour Formulations can be assessed for safety under the Dangerous Preparations Directive according to the conventional method. This takes into account the percentage and type of hazardous ingredients, applies some complex calculations and gives safety information appropriate to the formulation.

We are currently in a transition phase, moving from the historical DSD/DPD requirements to those of the Globally Harmonised System. This is a complicated time!

REACH

REACH is a European regulation. The main requirement of REACH passes onto industry the requirement to fully assess and consider the safety of chemicals used as such, in mixtures and articles - everywhere in the EU.

REACH regulations required a change to the Safety Data Sheet format amongst many other things. REACH Annex II on Safety Data Sheet compilation and format has been significantly modified and is more complex than ever before, particularly during the transition phase.

Global Harmonised System (GHS)

GHS had lofty goals of a Global Harmonised System for the classification and labelling of safety information across the globe. Japan and Europe are two of the earliest groups to adopt the GHS legislation. GHS has a tool box approach which give different countries the ability to select the most relevant classifications for them. For example not every country is adopting all the environmental classifications. Practically, this means for the same product marketed globally, there could be different labelling requirements.

In Europe GHS has been adopted as REGULATION (EC) No 1272/2008, on classification, labelling and packaging of substances and mixtures (CLP).

In Europe, from December 2010, ingredients must be labelled in accordance with CLP. Safety Data Sheets should contain both DPD (Dangerous Substances Directive) and CLP classification and information. It is possible to undertake CLP classification earlier than this.

For mixtures, from June 2015, the GHS requirements for labelling and Safety Data Sheets will become mandatory. Again, it is possible to undertake CLP classification earlier than this.

There are many additional responsibilities, for example notification to the Classification and Labelling Inventory. An abbreviation is all hazardous substances, irrespective of quantity used must be notified. The notification must be done with a month of placing a hazardous substance on the market, either as such, or by importing it in a mixture. More information can be found on the ECHA web site.

 

GHS Information about the labelling of ingredients and essential oils used in the flavour and fragrance industry started to become available in 2009, with further information available in 2010 and on an ongoing basis. There is more work to be done. REACH, with it's additional safety requirements, will also impact the classification of ingredients, and therefore mixtures. As REACH develops, further information will start to be needed on the Safety Data Sheet, for example supported usages and in some cases and Chemical Safety Reports.

Regulation Expert Safety Data Sheet Services

MSDS compilation can be undertaken for any Fragrance, Flavour or Essential Oil formulation. In addition, training can be provided in compiling these complex safety data sheets and the hazard assessment processes.

We use Industry Standard safety information from EFFA (European Flavor & Fragrance Association) and IFRA (International Fragrance Association) alongside any individual information you have. We can assess formulation safety and prepare REACH Annex I or Annex II compliant Safety Data Sheet for you to use as required.

Regulatory Help

 

The MSDS includes Hazards Identification & Transport Information, amongst many other Sections required by the legislation.

 

We are available with expert & confidential help with:

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Software

If you are looking for Software to manage Safety Data Sheet requirements please check out Formpak