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REACH Annex II: Building a safer future through proactive emergency response

18 Nov 2024

Effective chemical incident response requires qualified experts, not just medical-focused advisory bodies, to mitigate risks and ensure safety.

REACH Annex II (SDS) is clear that, in Europe, the provision of an Official Advisory Body (OAB, local Poison Centre) number in section 1.4 can suffice for emergency response purposes, while complying with this regulation:

“If an official advisory body exists in the Member State where the substance or mixture is placed on the market (this may be the body responsible for receiving information relating to health referred to in Article 45 of Regulation (EC) No 1272/2008), its telephone number shall be given and can suffice.”

But in reality, does it suffice? No, it does not. And for several reasons.

There are plenty reasons why this is insufficient. Whether this is insufficient because European regulations demand something else, whether the intended effect of the regulation expects different actions, or where organisational risk is not effectively managed by this approach.

Alongside the regulations themselves, ECHA publish guidance documentation to how to comply with the regulation. This guidance document very clearly states:

“Please note that although the official advisory body may be appropriate, there may also be cases where certain Member States have an advisory body for medical personnel only to contact. In such cases if the telephone number is given in an SDS it should also be explicitly stated in the SDS that it is intended for use by medical professionals only.”

Ricardo have contacted many OABs across Europe to establish their capability in response and whether they are able to provide advice beyond medical emergencies. All respondents confirmed that their emergency number can only be used for medical emergencies. Specifically, Poland also clarifies that “placing just the number 112* is not enough” and that an emergency number belonging to a supplier, or a competent third-party provider must be displayed. Based on Ricardo’s research and knowledge of the European Poison Centre landscape, we are not aware of any OAB which can provide more than just advice for medical emergencies.

*112 is the general emergency telephone number for members of the public in Europe, serving as the equivalent to 911 in the US and 999 in the UK.

This is reinforced by Article 45 of the Classification Labelling and Packaging Regulation (CLP) which sets out the requirement to submit product notifications to the official advisory bodies with the clear expectation that they only provide support to emergent health incidents.

Reading the guidance in conjunction with the regulation, and also with Article 45 of CLP, emphasises that including OAB numbers in section 1.4 does not suffice in totality, and is only suitable from the perspective of medical emergencies.

Is English OK?

A common question we get is around the language of a response solution in Europe. We find that that many organisations read the REACH Annex II text and assume that English language (or a single language of their choosing) is acceptable for SDS. Indeed, this is not the case, as the guidance documentation states:

“These services should be able to address requests/calls in the official language(s) of the Member State(s) for which the SDS is intended. Appropriate international dialling codes should of course be indicated as part of telephone numbers outside the country of supply of the substance/mixture referred to.”

As SDS must be produced in the official language of the Member State, there is a clear requirement that a local language response must be available through the emergency number.

And industry agree.

Alongside the regulations, there is also an ingrained expectation from industry themselves that OAB numbers only on section 1.4 cannot suffice.

The European Chemical Industry Association’s guidelines for Level 1 Chemical Emergency Response (available here) – which is also supported by other Industry Associations, in particular FECC (European Association of Chemical Distributors) – outlines what best practice emergency response looks like.

The guidance states that:

“The role of the Level 1 responder is first to mitigate the risk of the incident to people, the environment, assets and reputation as much as reasonably possible from a remote location.”

This expectation is clearly beyond that of an Official Advisory Body which only provides medical advice. The guidance goes on to state:

“In addition, the emergency response specialist should be a technically qualified, university graduate chemist, or have a similar high-level qualification (e.g.: chemical engineering, biochemistry, environmental protection) that is sufficient to give them an expert knowledge and understanding of chemicals, chemical behaviour and hazards across a range of incident types.”

Emergency response numbers therefore must connect to an individual who has the capability, knowledge and experience to provide direct advice to a wide range of chemical incidents, not isolated to just medical emergencies.

Is it right for you?

Emergency response telephones numbers are not intended to be a compliance tool. They are fundamentally a risk management tool, which the regulations are intending to reinforce is taken seriously. The Code of Federal Regulations Title 49, in the USA (CFR 49), is a Department of Transport regulation that incudes hazardous materials transportation.

This sets this expectation out clearly:

“The telephone number of a person who is either knowledgeable of the hazardous material being shipped and has comprehensive emergency response and incident mitigation information for that material, or has immediate access to a person who possesses such knowledge and information.”

Only using the OAB telephone number is essentially delegating your organisational risk management to a third party, and one which is extremely limited in their own response.

Looking at the incidents that Ricardo have received over the last 12 months, 13% of these cover what would be considered an acute medical incident. This leaves 87% of calls that, if you only displayed the OAB’s number on your SDS, would go unanswered.

OAB’s have limited ability to respond in these situations. There may be an alternative emergency number, if you included one in your notification, but typically they would just refer the caller back to the supplier. Which, if there is no alternative number on the SDS, would be very difficult for the caller to find the right person to contact. And whist they were trying to work this out, the incident could be getting worse, and more people could be at risk of harm.

Official Advisory Bodies do an extremely difficult job very well. They support the emergency services and physicians to identify and treat acute, critical and often complex medical cases involving chemical exposure and poisonings. Their contribution to public safety must be celebrated. However, by their own admission, their capability is limited to just this field. Putting the safety of your customers, and those in the supply chain, onto these organisations is unfair on them and their expertise, whilst also creating significant financial, legal and reputation risks to your own.

Only through the implementation of a robust and established emergency response programme, where advice can be sought by experienced and qualified chemical response professionals about the response to a range of chemical incidents, can you ensure you are effectively protecting people, the environment, assets and reputation.