Biocidal Products Directive (BPD)
The Biocidal Products Directive (BPD), Directive 98/8/EC, entered into force on 14 May 2000.
The Directive has three main objectives:
- to harmonise the European market for biocidal products and their active substances
- to provide a high level of protection for people, animals and the environment through risk assessment
- to ensure products are sufficiently effective against the target species
The Directive aimed to review all notified existing active substances that were on the market on 14 May 2000, during a 10-year review programme. All new active substances would be evaluated prior to their marketing.
The Directive has been amended several times to include new or existing active substances approved under the Directive (Annex I of the Directive - Annex 1 approvals).
Revision of the BPD
On 12 June 2009, the European Commission adopted a proposal for a Regulation concerning the placing on the market and use of biocidal products (COM(2009)267). It will repeal and replace Directive 98/8/EC.
The Regulation aims to improve the functioning of the internal market in biocidal products while maintaining the high level of the environmental and human health protection. The proposal will build on the principles laid down in Directive 98/8/EC, in particular the two-tier authorisation process: firstly, the inclusion of the active substance in Annex I and secondly, the authorisation of the biocidal product. The proposed regulation is scheduled to enter into force on 1 January 2013.
Further information on the EU Biocidal Products Directive/Regulations can be obtained here
The testing requirements for active substances under the 23 product types is available on the European Chemicals Bureau Website on Biocides
Testing Requirements
As well as a core data set required for registration, there are specific additional data requirements depending on the biocidal product type. Brixham Environmental Laboratory is experienced in designing the appropriate testing strategy for a particular biocidal product and in agreeing that strategy with the regulatory authorities.
Study Capabilities
Brixham Environmental Laboratory is able deliver all studies required for the environmental component of the submission, including the following studies that are listed within the Directive.
| STUDY | GUIDELINE |
| Physical and Chemical Properties | |
| Melting Point/Melting Range | OECD 102 |
| Vapour Pressure | OECD 104 |
| UV-Visible Absorption Spectrum | OECD 101 |
| Water Solubility | OECD 105 |
| Dissociation Constants in Water | OECD 112 |
| n-Octanol/Water Partition Coefficient | OECD 107 or 117 |
| Ecotoxicological Studies | |
| Freshwater Algal growth inhibition | OECD 201 |
| Freshwater Daphnia immobilisation | OECD 202 |
| Freshwater/Saltwater Fish acute toxicity | OECD 203 |
| Effects on micro-organisms e.g Activated Sludge Respiration Inhibition or Pseudomonas putida | OECD 209, ISO 10712 |
| Inhibition of microbial activity | OECD 216, OECD 217 |
| Bioconcentration in fish | OECD 305 |
| Ready Biodegradability Test | OECD 301A-F |
| Inherent Biodegradability | OECD 302A-C |
| Hydrolysis | OECD 111 |
| Photolysis | OECD 316 |
| Adsorption - Desorption | OECD 106/ OECD 121/OPPTS 835.1110 |
| Biodegradation in seawater | OECD 306 |
| Aerobic biodegradation (STP) | O 303 A, OECD 314A-E (excl. C) |
| Anaerobic biodegradation | ISO 11 734, OECD 314C |
| Aerobic aquatic degradation | OECD 309, ISO 14 592OPPTS 835.3100 (non adapted organisms) |
| Water/sediment degradation | OECD 308 |
| Aerobic degradation in soil | OECD 304A, OECD307 |
| 7.4.3.1 Prolonged toxicity to an appropriate species of fish [Ann. IIIA, XIII.2.1.] | O 204 |
| 7.4.3.2 Effects on reproduction and growth on fish [Ann. IIIA, XIII.2.2.] | O 210 O 212 O 215 |
| 7.4.3.3 Bio-accumulation in an aquatic organism [Ann. IIIA, XIII.2.3.] | |
| 7.4.3.3.1 Bio-accumulation in an appropriate species of fish | O 305EC C.13 |
| 7.4.3.3.2 Bio-accumulation in an appropriate invertebrate species | US 850.1710 |
| 7.4.3.4 Reproduction and growth rate of an appropriate Invertebrate species [Ann. IIIA, XIII.2.4.] | O 211 Danish Standard 2209 Bryant et al 1985 US 850.1350 |
| 7.4.3.5 Effects on any other specific, non-target organisms (flora and fauna) [Ann. IIIA, XIII.3.4.] | |
| 7.4.3.5.1 Effects on sediment dwelling organisms | TGD (EC) 1996O 218ASTM E 1383 |
| 7.4.3.5.2 Aquatic plant toxicity | US 850.4400 |
| 7.5 Effects on terrestrial organisms | |
| 7.5.1.2 Acute toxicity to earthworms or other soil non-target macro organisms | EC C.8O 207 |
| 7.5.1.3 Acute toxicity to plants | O 208 |
| 7.5.2.1 Reproduction study with earthworms or other soil non-target macro-organisms | I 11 268 (part 2) I 16 387 I 11 267 (draft) |
| 7.5.2.2 Long-term test with terrestrial plants | No guidance |
| 7.5.3.1.1 Acute oral toxicity [Ann. IIIA, XIII.1.1.] | S 1995 |
| 7.5.3.1.2 Short term toxicity [Ann. IIIA, XIII.1.2.] | O 205 |
| 7.5.3.1.3 Effects on reproduction [Ann. IIIA, XIII.1.3.] | O 206 |
| 7.5.4.1 Acute toxicity to honeybees and other beneficial arthropods [Ann. IIIA, XIII.3.1.] | O 213 &/or O 214 EPPO 170 IOBC 1985 BBA Part VI, 23-2.1.1; 23-2.1.5; 23-2.1.10 |
| 7.5.5 Bioconcentration, terrestrial [Ann. IIA, VII.7.5] | |
| 7.5.5.1 Bioconcentration, further studies (earthworms) | I 11 268 (part 3) |
