Low Risk Biocides Get a New Lease on Life Under the Biocidal Products Regulation

One of the significant failings of the Biocidal Products Directive (BPD) (98/8/EC) was the removal from the market of many commodity chemicals that are considered low risk biocides because of the cost associated with securing product approvals. The BPD attempted to make special provision for such low risk biocides by establishing an Annex IA for qualifying active substances and streamlining the registration of biocidal products containing List IA actives as long as the products do not contain any substances of concern. However, few applications for listing actives in Annex IA have been submitted because an Annex IA listing requires a full dossier (thus, there is no reduction in data requirements or costs for the active substance).

 

Annex I Low Risk Actives under the BPR

 

The new Biocidal Products Regulation (PE-CONS 3/12), adopted on 10 May 2012, and entering into force on 1 September 2013 with a transitional period for certain provisions, remedies the situation by establishing an Annex I list of low-risk actives. There are currently 19 substances on Annex I selected among substances identified as presenting a low risk under Annex IV to Regulation (EC) No 1907/2006 (REACH) or Annex IA to Directive 98/8/EC, substances identified as food additives, pheromones and other substances considered to have low toxicity, such as weak acids, alcohols and vegetable oils used in cosmetics and food. Article 28 of the BPR authorizes the European Commission to amend the list to add additional substances as long as they do raise health or safety concern.^[1] Substances not eligible for Annex I inclusion are substances that:

 

 

 

(a) meet the criteria for classification according to Regulation (EC) No 1272/2008 (CLP) as:

• explosive/highly flammable;
• organic peroxide;
• acutely toxic of category 1, 2 or 3;
• corrosive of category 1A, 1B or 1C;
• respiratory sensitizer;
• skin sensitizer;
• germ cell mutagen of category 1 or 2;
• carcinogen of category 1 or 2;
• human reproductive toxicant of category 1 or 2 or with effects on or via lactation;
• specific target organ toxicant by single or repeated exposure; or
• toxic to aquatic life of acute category 1;

(b) are PBTs or endocrine disruptors;

(c) have neurotoxic or immunotoxic properties; or

(d) give rise to an equivalent level of concern based on reliable information.

 

Simplified Authorization Procedure

 

Per Article 25 of the BPR, biocidal products containing Annex I actives are eligible for a simplified authorization procedure if all of the following conditions are met:

(a) all the active substances contained in the biocidal product appear in Annex I and satisfy any restriction specified in that Annex;

(b) the biocidal product does not contain any substance(s) of concern;

(c) the biocidal product does not contain any nanomaterials;

(d) the biocidal product is sufficiently effective; and

(e) the handling of the biocidal product and its intended use do not require personal protective equipment.

 

The simplified authorization procedure under Article 26 BPR involves submission of an application to the European Chemicals Agency (ECHA) informing it of the name of the competent authority of the Member State that the applicant proposes should evaluate the application and providing written confirmation that the competent authority agrees to do so; providing a summary of the biocidal product characteristics including the basic information referred to in points (a), (b) and (e) to (q) of Article 22(2) of the BPR, as applicable, along with efficacy data, and any other relevant information in support of the conclusion that the biocidal product meets the conditions laid down in Article 25; and payment of the evaluation fee as specified by the evaluating competent authority. Within 90 days of the payment of the fee, the evaluating competent authority must authorize the biocidal product if satisfied that the product meets the conditions laid down in Article 25. The evaluating competent authority may ask for additional information if needed to evaluate the product, however.

 

A biocidal product authorized in accordance with Article 26 may be made available on the market in all Member States without the need for mutual recognition. However, the authorization holder must notify each Member State no later than 30 days before placing the biocidal product on the market within the territory of that Member State and must use the official language or languages of that Member State in the product's labeling, unless that Member State provides otherwise (Article 27 BPR).

If another Member State considers that a biocidal product authorized in accordance with Article 26 has not been notified or labeled in accordance with the Article 27 requirements above, or does not meet the requirements of Article 25, it may refer that matter to a "coordination group" comprised of the Commission, the ECHA, and the Member States for appropriate action (Article 27(2) BPR). A Member State having legitimate concerns may provisionally restrict or prohibit making available on the market or use of the product on its territory pending the outcome of the coordination group process (Art. 27(3) BPR).

 

 

 

Adding New Substances to Annex I

 

The Commission is authorized under Article 28 BPR to add substances to Annex I provided the substances do not give rise to concern because:

(a) they meet the criteria for classification according to Regulation (EC) No 1272/2008 as:

• explosive/highly flammable;
• organic peroxide;
• acutely toxic of category 1, 2 or 3;
• corrosive of category 1A, 1B or 1C;
• respiratory sensitizer;
• skin sensitizer;
• germ cell mutagen of category 1 or 2;
• carcinogen of category 1 or 2;
• human reproductive toxicant of category 1 or 2 or with effects on or via lactation;
• specific target organ toxicant by single or repeated exposure; or
• toxic to aquatic life of acute category 1;

(b) they fulfill any of the substitution criteria set out in Article 10(1) BBR; or

(c) they have neurotoxic or immunotoxic properties.

Active substances also give rise to concern, even if none of the specific criteria in points (a) to (c) above are met, where a level of concern equivalent to that arising from points (a) to (c) can be reasonably demonstrated based on reliable information.

 

Given the cost associated with product approval for standard biocides under the new BPR, companies should take advantages of the simplified authorization procedure and also explore opportunities to have additional substance added to Annex I. Possible candidates include substances on the U.S. EPA list of minimal risk pesticides at 40 CFR 152.25(g) (1). Also, because imported treated articles are now within the scope of the BPR, there will be a critical need for the availability of biocides authorized for such uses in the EU. Listing on Annex I provides a practical way of meeting this need.

For assistance in complying with the above obligations, please contact Herbert Estreicher at +1 202.434.4334 or estreicher@khlaw.com.

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The Brussels office of Keller and Heckman LLP has been assisting clients on the Biocidal Products Directive and the National transitional schemes for biocides for a number of years. For further information, please contact Herbert Estreicher (+1 202.434.4334, +32 (0)2 645 50 96, estreicher@khlaw.com).