In April 2016 ECHA released a preliminary draft of the European XML-format on harmonised product notification. The format is supposed to standardise the variety of formats and possibilities of product notification within the EU and to ease the situation of importers and producers of chemicals, biocides, cosmetics and detergents.
A first assessment of the draft:
Overview of the required tasks
- Administrative data: Version of reporting format, reporting EU-member state, date and time of transmission
- Information about the reporting company: company name, address, telephone number, E-Mail address and VAT
- Contact information: name and telephone number for fast access on product information, name and number of the manufacturer of the product and name and number of the know how carrier of the formulation.
- Information on mixture: aggregate condition, colour, relevance of pH value and pH value, Unique Formula Identifier (UFI), toxicological data, GHS classification, GHS labelling and the composition
- Composition: composition is distinguished between substances, mixtures of substances and generic components. The concentration, be it exact or approximate, must be defined for all components. Furthermore, the classification of all components is to be stated. Substances need to be identified by their chemical name, CAS, EC and index number. Mixtures are to be specified by name, UFI and company data. Fragrances and colorants can be specified as generic components.
- Product details: Several products can be reported per formula. There must be stated: trade name, intended use (one to three options – end consumer, industrial, professional), product category as defined by new categorization and information about package size and packaging type. It is also possible to state any identifiers of the product such as product number, EAN-Code, etc as further identifiers. As an option, safety data sheets for each product and language can be transferred as attachment of the notification.
Comparison to the BfR-format, currently used in Germany
Compared to the XML-Format of the Federal Institute for risk assessment (BfR, Bundesamt für Risikobewertung), which already electronically transfers product notifications in Germany, the required indications are very similar. Following differences can be mentioned:
Unique Formula Identifier (UFI)
Mixtures will include an UFI Code that links them to their ingredients. This code must be displayed at the product label. The UFI changes with the wording. Companies create this code with an UFI generator. The UFI Code solves the problem of an (unknown) mixture within a composition. It is not necessary to know the exact composition of the mixture of the supplier of the notification. The UFI of the mixture is sufficient. In contrary, the BfR-format requires the exact composition.
One mixture – many products
The EU-format data model permits notification on several products regarding the same mixture. This resembles very closely the common data models and suits the SAP EHSM data model very well. In the standard data model, mixture corresponds to real substance and products correspond to the materials assigned. Das Gemisch entspricht im Standarddatenmodell dem Realstoff, die Produkte den zugeordneten Materialien. With BfR-format, the product name is leading. This is why information about mixture is reported repeatedly for products of the mixture when the product names vary.
Identification of the company is based on value added tax ID. The Federal institute of risk assessment (BfR) identifies producers or placing on the market by BfR-company code.
Categorisation of products
The new system for product categorisation, which is expected to be available end of 2017, allows the EU to identify a statistical analysis of incidents possibly needing risk minimization measures. The product classification complies with use categories of BfR-Format.
Further information on harmonisation:
No central data base
Notifications must be submitted to national authorities since there will be no central European database.
The language used will be the official language of the reporting country or, if accepted, English.
Existing notifications remain valid
Existing notifications remain valid until 2025 in so far as there are no significant changes in composition.
The EU-format has been published as preliminary draft in April 2016. The realization of the appropriate CLP regulations and the publication of the final format are planned for the years 2016 and 2017. Also, the provision of the UFI generator and the new product categorisation system is to be expected until end of 2017.
Solution for all customers of SAP EHS Management
opesus EHS Product Notification (EPN) will support the upcoming EU XML and represents a comfortable and reliable way to allow customers of SAP EHS Management fulfil their reporting obligations. EPN is the preferred software solution of SAP EHS Management customers for reporting notifications in Germany and Switzerland.
Link Poison Centers: https://poisoncentres.echa.europa.eu