What are biocides?
What are the regulations?
What are the consequences for you?
What can we do for you?

What are biocides?

Biocides are active substances (chemical substances or microorganisms) that are designed to deter, neutralise or destroy harmful organisms. Pests include insects, rodents, algae, fungi and bacteria. Biocides are therefore contained in numerous products that we use in many areas of private or professional life: for example, antibacterial cleaning and disinfecting agents, wood preservatives, mosquito repellents and ant poisons. However, the biocidal active ingredients themselves pose health risks.

What are the regulations?

Since the end of 2003, biocides have been subject to authorisation throughout Europe. The European Biocides Regulation (Biocides Regulation EU No. 528/2012) replaced the previous Biocides Directive 98/8/EC on 1 September 2013. The authorisation of biocides is now carried out in two stages: The first step is to check whether the active substances contained in a product have already been included in the Union list of approved active substances (positive list). Only these may be used. In the second step, the manufacturer in the EU member states must submit an application for authorisation of the biocidal product. The European Chemicals Agency (ECHA) and the authorisation bodies of the member states are responsible for this.

The aim of the ordinance is to ensure that only tested biocidal products are placed on the market whose effects on humans and the environment have been assessed as acceptable and which are sufficiently effectived.

What are the consequences for you?

All biocides already on the market are currently being tested in an "existing active substance programme". The risk for consumers, the environment and employees as well as the efficacy are being investigated. Only active substances for which there is no unacceptable risk when used as directed will be included in the Union list. Where appropriate, the active substance will be subject to conditions and restrictions on use. Biocidal active substances which are not included in the positive list may no longer be used.

Biocidal products containing so-called existing active substances are subject to a transitional regime and do not have to be authorised but notified. This notification is free of charge and can be made via an online form. According to the Biocide Notification Ordinance from the Chemicals Act, the trade name of the biocidal product as well as the name, CAS and EC number of the biocidal active substance must be indicated. If a biocidal product is marketed under different trade names, several notifications are required.

If a manufacturer wants to market a biocidal product with so-called new active substances, he must submit an application for authorisation. The requirements for the inclusion of active substances in the Union list are the same as for existing active substances. As soon as the active substances are on the positive list, the manufacturer can submit an application for approval of the product within 12 months. However, the application must be submitted in the EU member state in which the product is to be marketed and is initially only valid nationally. If the product is to be marketed in other EU countries, an application for mutual recognition of the approval must be submitted.

In addition, biocidal active substances must be labelled accordingly on the packaging since 1 December 2010 and biocidal products since 1 June 2015 (CLP Regulation).

For the purposes of material compliance, manufacturing companies in the automotive sector, for example, must check whether biocides are contained in their own products and whether they are prohibited under the Biocides Ordinance. In the first case, these must be documented accordingly in the material reporting system. In the second case, measures must be taken to ensure that the biocide is no longer used. Important: It is absolutely essential to check whether biocides are contained not only in the product itself but also in the packaging, as they can migrate from the packaging into the product.

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