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Creating and submitting a safety data sheet, basically a digital document, has technically never been as easy as today. But how about the quality?

Receivers and users of chemicals have “forever” been complaining that many safety data sheets do not meet their expectations. A similar message was heard just before Christmas from the European authorities’ enforcement project on classification and labeling of mixtures in the EU market. With all REACH data and IT tools available, a competent and responsible actor should already be able to prepare good quality documents. Nevertheless, safety data sheets do have many kinds of users, with conflicting expectations and increasingly more frequent updating requirements. Maintaining sheets up to date is therefore not an easy task. But as the complaints of low quality seem to persist, there might be reasons behind to explore.

If chemicals’ hazards are not right, how can any receiver, user or decision maker get reliable information from safety data sheets?

To me as a regulatory professional, the fundamental core is whether chemicals’ hazards are correctly identified, labelled and communicated in the supply chain. This refers indeed to the inspected sections 2, 3, 9, 11, 12 and 16 of safety data sheets. If these are not right, how can any receiver, user or decision maker get reliable information about the chemical hazards and risks of their products and materials?
For improving the availability of reliable information on chemical hazards, I’d pay attention to few important practicalities having recently come across.

The key role of the EU importer

The first issue is a reminder of the key role of the EU importer. In global supply chains the EU importers should be the ones implementing the world’s most ambitious regulations to their chemicals. Do EU importers get reliable information for identifying the most hazardous substances in the EU, starting typically from 0.1 % concentrations? A supplier safety data sheet created in the country of origin is not enough. EU regulations are not globally valid.

Not all chemicals on the EU market need to be comprehensively tested in low volumes

Secondly, not all chemicals on the EU market need to be comprehensively tested in low volumes. Hazard data, especially on chronic properties can still be lacking “legally”. The main regulation CLP, detailing classification and labeling rules for marketed products (mixtures), does not require additional testing. REACH should take care of that in the background, generating hazard data for component substances. However, REACH testing requirement starts from volumes of one tonne per substance, extending to chronic endpoints from 100 tonnes on. Eventually, classification of the most hazardous substances (carcinogens, mutagens, reproductive toxicants, respiratory sensitizers; persistent, bioaccumulative and environmentally toxic or mobile substances; and especially endocrine disruptors) are ultimately harmonized by authorities’ assessments. Classification process for harmonized chronic hazards may take many years.

How to find reliable information of new alternatives not yet properly tested?

If someone is looking for new alternatives, for example to substitute an existing hazardous chemical, finding new reliable information can be challenging. If the quality of suppliers’ safety data sheets is low, or the most hazardous properties are not yet allowed to be tested, how to make well informed decisions on the best alternatives for future products?

Benefits of quality

Ultimately, poor quality safety data sheets may result in biased business decisions and investments. They may cause operational delays and surprises regarding usability of the raw material, product, application or access to market. They add operational costs and workload for the whole supply chain, and the big picture might be lost. From the occupational health and safety point of view, missing information on hazards and risks hinder their proper identification, management and communication.

Ability to provide good quality safety data sheets, correct labels and ultimately safer products in a timely manner tells a lot about the quality and responsibility of the supplier. If generated early enough, high quality information will enable early identification and investments on sustainable products and technologies and prevent wasting resources on hazardous sunset chemicals. Forerunners will benefit from their strategic investments on good quality information, enabling fact-based decisions.

In the real life, the trickiest question nevertheless remains: which quality is good enough? Good quality is always fit for purpose for the users, and the result of continuous improvement.

Contact:

Helena Niemelä

Leading consultant

helena.niemela@ecobio.fi

This article reflects the views of the author, with 15 years’ experience on REACH implementation and submissions of nearly 100 REACH registrations, providing data content to numerous safety data sheets. Ecobio can help our customers also in improving the quality of their key safety data sheets. Read more about our services

An important milestone for the European chemical industry has been reached as the final REACH registration deadline for substances passed in 31.5.2018. The European REACH Regulation ((EC) No 1907/2006), however, continues to set high standards for the whole industry, from manufacturers, importers, formulators and distributors all the way down to downstream and end users.

Effects on the supply chain

Whilst the REACH registration deadline passed in 31.5.2018 already, it can take up to 3 months for the European Chemicals Agency ECHA to make a registration decision; your supplier might be fully REACH compliant if they have submitted their dossier on time, but might not yet have received a registration decision, i.e. a registration number, from ECHA. In complex cases where an extension might have been received from ECHA and the Director’s Contact Group, receiving a registration decision will take even longer than that.

This also means that the potential effects of the last registration deadline that mainly dealt with SMEs and their substances might affect supply chains with a delay. Whether or not the registering company had enough assets and know-how to pull through the registration might become evident only later on. If a company has decided to cease their manufacture by 31.5.2018, they are still allowed to sell all their supply gathered before the deadline to downstream users as distributors. Whether or not some companies or some products might be dropping out, or the market become more homogenized, will most likely be found out only after the dust of the final registration deadline has settled.

Communicating REACH compliance to authorities and stakeholders

In terms of supply chains and their continuance, it is important to notice that pre-registration numbers are no longer valid. It is also important to notice that either a generic or a company-specific version of the actual REACH Registration number can be put forward. The company-specific version always consists of four parts of numbers, e.g. 01-2119458769-17-0003, whereas the generic form might only consist of three (e.g. 01-2119458769-17 or 01-2119458769-17-XXXX). Make sure that your suppliers have actually registered the substance in their name, and are not just giving you a generic number to keep you content for a while.

A good way to communicate a company’s adherence to REACH and its many requirements is a REACH declaration of compliance. Such a statement can serve as a testimony to the authorities or as communication to customers and other stakeholders to show that your company is indeed REACH compliant in all the relevant aspects of the REACH Regulation. Such a statement is a hard asset outside of Europe as well.

A shift in focus towards formulators

As the burden of REACH has previously been mainly on substance manufacturers and EU importers, the focus of the regulation is now shifting towards formulators. The safe use of mixtures is a topic that will need to be addressed by operators in the coming years in the form of unique formula identifiers (UFI) and poison centre notifications (PCN). This will require a thorough knowledge of the composition and hazardous properties of the supplied mixtures as well. Exposure scenarios and their utilization in communicating the safe use of mixtures will surely be giving formulators some gray hair.

Increasing amount of regulation

As ECHA is now the holder of the world’s largest open database of substance information, plans on how to best utilize the gathered information on the registered substances are big. On a general level this might mean more substance restrictions and harmonized classifications. Manufacturers of highly hazardous substances or those who have submitted incomplete information, on the other hand, might become a target for even more scrutiny.

Reaching the legislative deadline will also most definitely result in increased supervision from national authorities on whether or not companies have fulfilled their various requirements under the REACH Regulation, with regard to substance restrictions and registrations especially. A more scrutinized assessment of SDS’s and of the responsibilities that downstream users have regarding exposure scenarios and their assessment against their own conditions could also result.

Harmonized classifications under the CLP Regulation ((EC) No 1272/2008) themselves can also be a source of restriction, as is now happening with titanium dioxide. A common chemical used as a pigment and thickener in a wide variety of applications for consumer use, including foodstuff, is about to receive a category 2 carcinogen classification, meaning heavy restrictions on its use in many of its current applications.

Competitive edge for European companies

One of the main original aims and visions of the comprehensive chemical legislation that is REACH is to ensure a high level of health and environmental protection. Another aim of the regulation has been to stimulate innovation and enhance the competitiveness of European brands on international markets. As chemical legislation is getting stricter all around the globe, REACH is indeed serving as an important example for other countries striving for increased chemical safety. This is one of the reasons why being REACH compliant is an asset all over the world; still today, REACH is the most advanced chemical legislation in the world.

Consumer image – a threat or a possibility?

An increasing amount of portals and sources for consumers on how to use chemicals safely and on how to find relevant safety information on chemicals have also emerged. Whilst a huge amount of scientifically-based information on chemicals and their safe use is now publicly available, what should never be underestimated is the opinion and views of the general public. Companies should therefore have an understanding of what the data gathered by them actually means and how it can be translated into facts and to transparent stakeholder communication.

Registration in the future

Now that all the three major deadlines for the REACH registration of chemicals in different tonnage bands have passed, the registration of future substances will require more planning in advance; as of now substances will need to be registered before manufactured or imported into the EU in amounts above 1 tonne per year. Make sure to make use of all the relevant exemptions to registration requirements. For R&D substances, for example, a PPORD notification will give your company a 5-year period of reflection before deciding on whether to continue with the substance or not. For substances produced in circular economy processes, further exemptions also apply.

For more of the concrete results that REACH keeps delivering, see the press release of the European Commission on the matter: http://europa.eu/rapid/press-release_IP-18-1362_en.htm

Leea Ojala, Senior consultant

20.6.2018, Helsinki

In case you have any questions about your obligations under the REACH Regulation or are interested in a REACH Declaration of Compliance or a screening of substance restrictions on your chemicals, contact Ecobio’s experts at: info@ecobio.fi or tel. +358 20 756 9450.

Tag: SDS

The quality of safety data sheets does matter