Frequently Asked Questions about the mandatory notification of detergents and cleaning agents
FAQs, 29 May 2007 Detergents and cleaning agents contain substances that may jeopardise the health of consumers. Certain ingredients like fragrances or preservatives can trigger allergic reactions in sensitive individuals. There are also repeated incidents of poisoning caused by people ingesting detergents or cleaning agents by mistake. Since the entry into force of the new Detergent and Cleaning Agent Act on 5 May 2005, manufacturers must report the formulations of their detergents and cleaning agents to BfR. That is why BfR has compiled the following FAQs on this new mandatory notification.
Why must the formulations of detergents and cleaning agents be reported to BfR?
So as to afford consumers even better health protection, manufacturers are obliged to notify the formulations of their detergents and cleaning agents to BfR. This information can then be used for emergency treatment in the event of poisoning accidents. On 5 May 2007 the amended Detergent and Cleaning Agent Act (Wasch- und Reinigungs-mittelgesetz, WRMG) came into force. It transferred responsibility for the receipt of these notifications from the Federal Environmental Agency (UBA) to BfR. The reason for this amendment was to bring German law into line with the EU Detergents Regulation.
To which detergents and cleaning agents does the mandatory notification obligation pursuant to WRMG apply?
All detergents and cleaning agents for commercial and private use must be notified. Dangerous preparations, biocide products (see below) and surfactant-containing cosmetics (for instance shower gel and shampoos) are exempt from the mandatory notification prescribed in WRMG. Other statutory provisions govern the notification of these products. For instance cosmetics are notified to the Federal Office of Consumer Protection and Food Safety (BVL) in connection with the enforcement of the Cosmetics Regulation.
What data must be notified?
Manufacturers must provide BfR with a data sheet with the complete formulation of the detergent or cleaning agent.
What does BfR do with the data?
As is the case with other product groups, BfR passes on the formulations of detergents and cleaning agents along with regular updates to the German poison information and treatment centres. They use the information for the emergency treatment of cases of poisoning. The data are treated confidentially and used within BfR for the assessment of poisoning incidents which physicians must report to it as part of their statutory notification duty. Pursuant to the Act, the BfR passes on the names of the products and manufacturers to the Federal Environmental Agency (UBA). UBA is the contact for the control authorities of the federal states and responds to inquiries about whether detergents and cleaning agents have in fact been notified.
Do detergents and cleaning agents, that have to be notified pursuant to § 16 e ChemG (Chemicals Act), also have to be notified under WRMG?
Detergents and cleaning agents which come under § 16 e will still be notified pursuant to the Chemicals Act. Manufacturers are bound to state in these notifications that the products belong to the group of detergents and cleaning agents. BfR then knows that it must pass on the names of the products and manufacturers to UBA. There is no need for a second notification pursuant to WRMG.
How are the data sent to BfR?
The data stipulated in the Act must be sent electronically to BfR. BfR has defined an exchange format for this purpose and developed an electronic reporting aid. Both are available free of charge on the BfR website.
Are there statutory transition periods for the later notification of detergents and cleaning agents?
Manufacturers must notify all detergents and cleaning agents which were placed on the market between 8 October 2005 (date of the entry into force of the EU Detergents Regulation) and 5 May 2007 (date of the entry into force of WRMG) to BfR by 4 July 2007. Since the entry into force of WRMG manufacturers must notify all other new products to BfR at the latest when they place them on the market.
Will there be a BfR number for the purposes of product identification similar to the old UBA number?
There will be a BfR number, similar to the UBA number, in future, a so-called product identification element (PI element). The PI element is the first step towards European product identification. It was proposed by BfR and its predecessor institutes and is the subject of a European standardisation procedure (CEN). The PI element consists of the five-digit BfR company code and a four-digit number allocated by the manufacturer itself. The number sequence ends with details of the hazard characteristics of the product (for instance, irritant, corrosive or toxic).
May the old UBA number still be used?
The UBA numbers will no longer be assigned but may still appear on existing products.
Do new products only have to be notified to BfR? What’s going to happen to the UBA database?
Only products placed on the market since 8 October 2005 must be notified to BfR. For legal reasons the UBA database may not be handed over to BfR. The formulations of existing products may not, therefore, be used for advice on poisoning or for the assessment of poisoning incidents.
What improvements will the new provisions mean for physicians and consumers?
When treating cases of poisoning or allergic symptoms, medical staff now has far faster access to product information and formulation ingredients. This applies both to consumer and commercial products. Furthermore, according to the new WRMG, the manufacturers of detergents and cleaning agents must also provide more information on their product labels than they did in the past: for instance ingredients like surfactants, phosphates or bleaching agents from a concentration of 0.2 weight percent must be stated on the package labels. Irrespective of the concentration, preservatives must always be listed as must allergenic fragrances from a concentration of 0.01 percent.