Lessons from the Enforcement of the EU Biocides Directive CEFIC 8th Legis Workshop May 17, 2011 Cándido García Molyneux [email protected] Covington & Burling LLP

Key Message Achievement of environmental and human safety objectives and of an internal market (fair competition) requires a EU institutionalized coordination of enforcement of chemicals rules

Challenges Regarding the Enforcement of the Biocides Rules • Need to comply at different levels in the supply chain • Long transitional review period for existing substances • Free riders

• Borderline issues • Poor enforcement and lack of EU coordination

Non-Compliances under the EU Biocides Directive •

•

Illegal biocidal product (BP): – Marketed as a non-BP (borderline issues) – Not authorized/registered under EU/national rules – Contains non notified substance – Contains withdrawn substance – Contains rejected substance – Does not comply with classification, labeling and packaging requirements – Does not comply with safety data sheet requirements – Does not comply with advertising rules (e.g., harmless, non-toxic) Illegal active substance for use in biocidal products – Not notified – Withdrawn or rejected – Does not comply with classification, labeling and packaging requirements

Transitional Review • Long transitional review (at least until 2014) – BP containing reviewed active substances subject to national (authorization/registration) rules – Significant differences among different national regimes – In effect, also affects definition of BP » and application of Directive’s requirements (e.g., labeling, advertising)

– BPs within same product type can be treated differently depending on whether substance’s review has been completed

Free Riders Two problems: 1.

During Transitional Review Period: Once one manufacturer of existing active substance notifies and submits dossier, all others can continue to market BP with that substance (in notified product type) subject to national rules

2.

Once BP is authorized: Manufacturer of BP could go to a supplier different than the one who supplied data for authorization –

Provided substance is “identical”

Borderline Issues • Medicines – Veterinary products -- Medical devices – Cosmetics – Foods – Other • Commission has developed guidance – Limited use during transitional period

• Commission request of information to MS on device with “silver nitrate” in 2010 “CE Medical mark 0499 - manufactured to ISO 9001/ISO 13485” “new generation of bio disinfectant, based on hydrogen peroxide stabilized by a colloidal silver complex (30ppm)” and to be “bactericidal, virucidal, sporicidal and fungicidal”

– Marketed in at least BE, CZ, FR, IR, IT, RO, SLOV, SE

• Articles and imported treated articles

Enforcement • Level of market surveillance and control varies significantly among MS • Lack of sufficient resources for enforcement in MS • Limited power of the Commission to force MS to ensure compliance during transitional review period

• No significant EU institutionalized coordination • Intra-Community trade – Internet sales

The Chemical Legislation European Enforcement Network •

EuroBiocides – Objectives • • • • •

– – – –

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Carry out harmonized European enforcement of Biocides Directive Learn about companies dealing with BPs and substances Provide better information on rules Prepare recommendations to Commission Training of officials (e.g., development of manuals with compliance check lists)

Focus on authorization of BP Around 14 MS participated Coordination by DE and DK authorities Enforcement took place in 2008 and report is expected in Sept. 2011

EuroBiocides II – Started in 2011 – Focus on BPs types rodenticides, insecticides, and repellents and attractants

Council Draft on Revised Biocides Regulation •

Limited improvement on enforcement (Art. 54) “Member States shall make the necessary arrangements for official controls to be carried out in order to enforce compliance with this Regulation” “Manufacturers […] shall maintain a suitable system of quality control of the manufacturing process” –

Explicit reference to Market Surveillance Regulation • •

MS may order withdrawal if (human or environmental) risk RAPEX (e.g, dimethylfumarate in shoes – 2009)

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Establishment of an EU register of biocidal products (Art. 60)

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Limited rules on free riders (Art. 83)

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Limited provisions on coordination – –

No explicit reference to ECHA Forum No clear mandate to Biocidal Products Committee on coordination of enforcement •

But some provisions of Arts. 65(1) and 66(2) could be used

Dr. Cándido García Molyneux Covington & Burling LLP 44 Avenue des Arts 1040 Brussels Belgium +32.2.549.5261 [email protected] Cándido García Molyneux is a Spanish of counsel in the Brussels office of Covington & Burling LLP. His practice focuses on EU environmental law and Spanish and Italian food and drug law. He advises clients on legal issues concerning environmental product regulation, chemical law, waste management, climate change, renewable energies, and energy efficiency. Cándido was actively involved in the legislative process resulting in the REACH Regulation, and now advises chemical manufacturers and downstream users and their trade associations on the impact of the REACH/CLP regimes and on how to best ensure compliance and defend their products. Dr. García Molyneux holds a PhD in Law from the European University Institute, an LLM from the University of Georgetown, and a Law Degree from the Autonomous University of Madrid. He is an external professor of environmental law and policy at the College of Europe. 11