A large number of products that contain chemical mixtures are placed on the EU market and used by the general public and professionals in their everyday lives and working environments. Generally, chemical products are considered to be safe if their use instructions are followed. However, inappropriate use or accidents can cause unintentional exposure and, in this case, immediate access to relevant information on the chemical product is crucial for medical staff and emergency responders.
In order to have this information readily available, EU council directives from as early as 1988 required Member States (MS) to appoint a body responsible for receiving information (i.e. chemical composition) relating to dangerous preparations/mixtures/products placed on the market. Therefore, many MS have had a system for collecting such information from companies in place for a long time as well as established bodies (poison centres) to provide medical advice in health emergencies. In the event of an accidental exposure or poisoning incident, depending on the MS, various stakeholders such as physicians and other medical staff, workers and the general public could contact the poison centres for advice on medical treatment. More recently, the CLP Regulation (EC) No 1272/2008, incorporated in Art 45 the requirement for MS to appoint a body for receiving information on the composition of hazardous mixtures to enable preventative measures and treatments to be put in place. However, the absence of harmonisation led to variation in the existing national notification systems, data formats and information requirements, leading in turn to inconsistencies in the information available to medical personnel in cases of accidental exposure or poisoning incidents in different MS. To address this issue a new Annex VIII entered into force in April 2017, setting provisions for the harmonisation of the format and content of the information to be submitted to the MS appointed bodies or poison centres.
The required information includes:
- Identification (Product identification, Submitter details, Details for rapid access to additional product information)
- Hazard identification (Classification and label elements, Toxicological information, Additional information)
- Information on the composition and hazardous ingredient substances
- Information on the intended use
The information must be submitted by electronic means in a specified format. A unique formula identifier (UFI) will allow the poison centres to unambiguously identify the composition of the mixture and propose the appropriate medical treatment in the event of poisoning.
The deadlines for submitting the information are:
- 1 January 2021 for mixtures for consumer or professional use
- 1 January 2024 for mixtures for industrial use
If the information has already been submitted before the date of applicability, a resubmission is not required until 1 January 2025.
The obligation for the submission falls on economic operators/companies carrying out import, formulation, repackaging, refilling and/or toll formulation activities. Distribution, retail, re-branding and/or re-labelling activities may require submission under certain circumstances.
Post submission, submitters must make sure that the submitted information is constantly up to date.
We can assist you with:
- ensuring you meet your obligations for appointed body/poison centre notification
- carrying out required submissions through the relevant online submission tools (e.g. IUCLID)
- generating UFI(s)
- keeping your submission up to date