In April 2016 ECHA released a preliminary draft of the European XML format on the harmonized product notification. The format is intended to standardize the variety of formats and possibilities of product notification within the EU and to ease the situation for importers and producers of chemicals, biocides, cosmetics, and detergents.
Here's a first assessment of the draft:
Overview of Required Information
- Administrative data
- The version of the reporting format
- The reporting EU member state
- The 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 to product information
- name and number of the manufacturer of the product
- name and number of the know-how carrier of the formulation
- Information on mixture:
- aggregate condition, color, the relevance of pH value, and pH value
- Unique Formula Identifier (UFI)
- toxicological data
- GHS classification, GHS labeling
- 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: the trade name, the 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 attachments to the notification.
Comparison to the BfR Format (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. The following differences can be mentioned:
Unique Formula Identifier (UFI)
Mixtures will include a UFI Code that links them to their ingredients. This code must be displayed on the product label. The UFI changes with the wording. Companies create this code with a 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. On 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 the 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.
Categorization of products
The new system for product categorization, 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 the use categories of BfR format.
Further Information on Harmonisation:
No central database
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 as long as there are no significant changes in composition.
The EU format has been published as a 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 categorization system is to be expected by the 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 to fulfill 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