Chemical products containing hazardous substances are expected to be safe when used according to instructions, however, adverse health effects due to accidents, inappropriate use or intentional misuse result in many calls being placed to Poison Centres throughout the EU. The main task of Poisons Centres is to inform medical personnel and the public about the poisoning risk of the exposure, symptoms and poisoning severity to be expected, adequate first aid measures and the best medical treatment options.
In order for Poison Centres to perform this task adequately, it is crucial that they receive information on the composition and properties of products placed on the market. To ensure this submission of information on hazardous mixtures by companies to Poison Centres, the European Commission has amended the CLP Regulation, by adding to Annex VIII on harmonised information relating to emergency health response.
EU Regulation 2017/542 amending CLP
EU Commission regulation 2017/542 amends CLP by adding the requirement to include a UFI to the product label (Article 25) and the inclusion of Annex VIII to the regulation.
Annex VIII of CLP aims to harmonise the information requirements for poison centre notifications, meaning that detailed, consistent information on hazardous mixtures will become available to all EU Poisons Centres. The implementation of a Unique Formula Identifier (UFI) will also mean that the mixture formula can be rapidly identified, which will lead to a better and more appropriate medical response, and at the same time, reduce the administrative burden and costs of submission for industry trading across the EU.
Mixture information requirements
Under the notification requirement, all importers and downstream users placing hazardous mixtures on the market, and distributors who modify the label or packaging for hazardous mixtures, will need to notify the ingredients in those mixtures classified as hazardous for physical effects and/or health effects.
The information that needs to be submitted includes:
- Identification of the mixture and the submitter
- Product identifier of the mixture — the trade name or names (including the brand name or other names)
- The unique formula identifier (UFI) of the mixture
- The name, address, phone number and email address of the submitter
- Hazards identification and additional information
- Classification of the mixture (hazard class and category)
- Label elements
- Hazard pictogram codes
- Signal word
- Hazard statement codes, including supplemental hazard information codes
- Precautionary statement codes
- Toxicological information
- Description of the toxicity of the mixture or its components (as required in Section 11 of the SDS)
- Additional information
- Colour
- pH (where applicable)
- Physical state
- Packaging (type and size)
- Intended use (product categorisation code)
- Uses (consumer, professional, industrial)
- Product identifiers of the mixture components
- Chemical/trade name of the components
- CAS number (where applicable)
- EC number (where applicable)
- UFI (where applicable)
- Exact concentration or concentration ranges of the mixture components
- Classification of mixture components (substances and MIM)
- Hazard classification of each component (where applicable)
- Additional identifiers (where applicable and relevant for health response).
Composition of the mixture
For Poison Centres to make an optimal clinical risk assessment in case of exposure to a product, it is necessary to access detailed product information, especially on the composition. The European Association of Poisons Centres and Clinical Toxicologists (EAPCCT) initially requested a complete formula of the mixture while industry preferred to submit the Safety Data Sheet (SDS) only, thus not meeting these requirements. On the SDS, classified components below a concentration threshold (0.1% or 1%) and non-classified components regardless of concentration do not need to be mentioned. PCs pointed out that non-classified components (e.g., sodium bromide, propylene glycol) may cause adverse health effects (poisoning, allergic reactions or by interaction with food or drugs) and are therefore of concern in individual risk assessments.
As a compromise, for mixture components classified for a health hazard or a physical hazard, a concentration threshold of 0.1% was accepted. Below this threshold, identified components (“known” by the company) must also be indicated unless the submitter can demonstrate that those components are irrelevant for the purposes of emergency health response and preventative measures. In practice, it is expected to come down to a complete list of components classified as such with exclusion of e.g. impurities. All other components, classified for an environmental hazard only or non-classified, have to be indicated if identified and present in the mixture in concentrations equal to or greater than 1%.
Generic identifiers for mixture components
Substances in the mixture must be indicated with their chemical name. By derogation of this requirement the generic identifiers “perfumes”, “fragrances” and “colouring agents” are allowed if the component (1) qualifies as such, (2) is not classified for any health hazard and (3) to the extent that the concentration of mixture components identified with a given generic product identifier does not exceed a total 5% for the sum of perfumes and fragrances and 25% for the sum of colouring agents.
Unique formula identifier (UFI)
After exposure, correct identification of the involved product is often problematic. Patients or medical experts have difficulties recognising the correct/complete trade name on the label. As a result, Poison Centres frequently experience problems linking a trade name reported on the phone to the corresponding mixture dataset in the PC product database. To solve this problem, the Unique Formula Identifier (UFI) was proposed. A UFI, both present on the label of a hazardous product placed on the EU market and in the submitted mixture information, will substantially improve product identification. Moreover, with the UFI being formula specific, composition changes over time under the same trade name, can now be distinguished.
Another benefit is the use of the UFI for the identification of “mixtures in mixtures”. When a mixture is used as a component in another mixture, the first mixture is referred to as a “mixture in mixture” (MIM). When a MIM composition is not made available to the submitting company due to confidentiality reasons, the MIM can be indicated with its UFI, trade name and concentration in the mixture. In this case, the MIM composition must be submitted separately (by another party) allowing PCs to deduce the complete composition.
The UFI is a 16-digit alphanumeric code presented in four blocks of four characters. This code is preceded by “UFI” (e.g., “UFI 18CV – C4HJ – P000 – DSFN”). The UFI excludes the letters “L”, “I”, “B”, “Z” and “O” to prevent confusion when read and communicated (“spell-by-phone-friendly”) and contains a check digit in order to verify whether the UFI is built correctly. The UFI is generated from the company’s VAT number, if the company is not registered for VAT, then there are provisions in place. This code must be placed on the product label and becomes part of the notification.
An online UFI generator application has been developed to allow companies to create UFI’s either singularly or in bulk. Alternatively, the UFI algorithm can be implemented by companies by their own IT system.
UseS
- Consumer use — a mixture intended to be used by consumers
- Professional use — a mixture intended to be used by professional users (but not at industrial sites)
- Industrial use — a mixture intended to be used at industrial sites only
ECHA is planning to release some guidance which will help to further define these definitions.
Group Submissions
Group submissions are permitted for mixtures in a group provided that all have the same classifications for health and physical hazards and all have the same product category code. Such groups can be notified in one submission. The concentration ranges must be the same for them all. Group submissions are also permissible for perfumes and fragrances provided that the total concentration of perfumes and fragrances contained in each mixture does not exceed 5 %.
Scope of the submission requirements
Some hazardous mixtures fall out of scope of the notification requirement and include those:
- classified as dangerous for the environment only
- classified as gases under pressure
- classified as explosive
- for scientific research and development (R&D) purposes
- for product and process-orientated research and development (PPORD)
- requiring a safety data sheet (SDS) but not classified as hazardous
- not in scope for CLP (eg waste, radioactive mixtures)
- not placed on the market, but finished products for defined markets.
Next steps
Companies are advised to start now to prepare for the new notification system by identifying deadlines relevant to their products.
Companies need to be ready with the UFIs on labels before their deadline to submit the product information to the Poison Centres. In practice, this means that the generation of UFIs and the printing of appropriate product labels should be carefully planned into your company’s schedule and can be executed in advance of the relevant submission deadlines.
New data submission requirements are set out in Annex VIII to the CLP Regulation and will apply from 1 January 2020.
The new requirements will apply from 1st January 2020 with the following phased deadlines:
- 1st January 2020 for consumer uses
- 1st January 2021 for professional uses
- 1st January 2024 for industrial uses
The message from ECHA is to:
- identify your obligations
- prepare your IT systems
- notify by the deadline
- keep your notifications up to date
Technical Tools
Technical tools to generate the electronic format and the UFI together with guidance documents are available from the European Chemicals Agency (ECHA).
Further information
The amendment can be accessed here, and can be downloaded as a PDF (in English): Annex VIII
Unique Formula Identifiers (UFIs).
https://poisoncentres.echa.europa.eu/questions-and-answers
Hibiscus Plc has been providing regulatory advice and labelling solutions for dangerous goods retailers and wholesale chemical suppliers for over 35 years.