The Biocidal Products Directive (BPD)
At the recent FRETWORK Forum, held in Brighouse, UK, the effects of recent changes in European Union legislation upon the use of antimicrobial products in textile materials were reviewed.
John Hubbard (SATRA, Kettering, UK) said that the Biocidal Products Directive (BPD) introduced via EU Directive 98/8 EC (16 February, 1998) covered the placing on the market of biocidal products (eg. such as antimicrobial finishes) and limited the use of the most harmful biocides, using an approach comparable to REACH. The BPD covered all products placed on the market that claimed biocidal properties, but did not include products used outside the EU for application on final products to preserve them during transit.
A biocidal product was defined as “active substances and preparations containing one or more active substances, put up in the form in which they are supplied to the user, intended to destroy, deter, render harmless, prevent the action of, or otherwise exert a controlling effect on any harmful organism, by chemical or biological means.”
Within the 23 Product Types (PTs) identified within the BPD, PT1 Human hygiene biocidal products and PT9 Fibre, Leather, Rubber and Polymer preservatives were clearly of relevance to textile materials and end-uses.
The BPD approach covered identification, evaluation and approval of biocidal active substances, with phasing-out of nonregistered active substances, or active substances for which technical dossiers were not submitted, or non-approved substances. Technical dossiers on active substances were assessed by competent bodies within EU Member States. Issues for consumer goods included products that claim antibacterial properties, eg. socks and underwear, which should only use approved products – although there was uncertainty over which product type applied (PT1 or PT9) and a decision was awaited. PT1 fell within Group 1 Disinfectants and General Biocidal Products; PT9 within Group 2 Preservatives, of the BPD.
John Hubbard pointed out that anti-mould treatments carried out prior to import to the EU were not covered by the BPD but this was being considered for potential future amendments. Remedial treatments carried out within the EU should be compliant with PT9.
To establish whether a biocidal substance was compliant with the BPD, it was necessary to determine:
• What is the name of the substance?
• What is the CAS number of the substance?
• What is the product type for the application?
• Is this an existing substance for this Product Type?
• Is there a decision on non-inclusion or phase-out?
The BPD authorised substances for use as biocides, but may limit use or put restrictions on the use. If the product had non-biocidal uses these would be considered under REACH.
The Biocidal Products Regulation (BPR)
On November 23, 2011, the EU Council’s committee of the permanent representatives of each member state (COREPER) approved a compromise agreement on the proposed EU Biocidal Products Regulation (BPR) that would repeal and replace the Biocidal Products Directive (BPD) (98/8/EC). Under the compromise reached by the EU Council and European Parliament, biocides would be reviewed regularly, with approvals or renewals valid for a maximum of 10 years, and less for ‘problematic’ substances. The scientific uncertainty about the safety of nanomaterials in the proposed legislation calls on the European Commission (EC) to regularly review the provisions on nanomaterials in the light of scientific progress. The EC’s recent recommendation on the definition of a nanomaterial is as follows:
“…‘nanomaterial’ means a natural or manufactured active substance or nonactive substance containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50% or more of the particles in the number size distribution, one or more external dimensions is in the size range 1nm-100nm.” It should be noted that
“Fullerenes, graphene flakes and single-wall carbon nanotubes with one or more external dimensions below 1nm shall be considered as nanomaterials.”
Under the proposed EU legislation, where nanomaterials are used in a product the risk to the environment and to health must be assessed separately. Labels would be required to include the name of all nanomaterials contained in biocidal products, followed by the word ‘nano’ in brackets.
On January 19, 2012, the European Parliament approved in Second Reading the Biocidal Products Regulation. The new regime is expected to be fully applied as of September 1, 2013. The BPR maintains the concept of the harmonised authorisation system for active substances used in biocidal products set up in the BPD (98/8/EC), but some important changes have been introduced.
Dr Ken Seal (Regulatory Affairs Director, Thor Specialities (UK) Limited, Northwich, UK) gave a biocide manufacturer’s view of the regulation of biocidal products in the EU, covering the need, complexity, cost, implementation and enforcement of the new BPR as well as the downstream implication and obligations.
Dr Seal said that, in his opinion, if REACH had been introduced first, the BPD would not have been needed. It had been introduced on the back of the Plant Protection Products Directive in 1998. In terms of complexity, the BPD had 63 pages and covered 400 substances with up to 23 application areas. Since its implementation in 2000 only 50 substances had been reviewed and the predicted completion date for review of 2014 could extend to between 2018 and 2025. There are many thousands of formulations which require authorisation and the BPD was regarded as the most complex piece of legislation in the EU.
The BPR addressed inadequacies and omissions in the BPD, and went much (but not all) of the way to satisfy industry’s concerns. Over 1,000 amendments had been tabled and about 250 incorporated into the final draft. The BPR would create an enormous resource requirement both for industry and national governments in order to process the authorisations.
In terms of cost it had originally been estimated that it would take 50 years for industry to recover the cost of the BPD. Thor was supporting 12 active substances with an average cost each of £3million. These 12 actives were used in over 300 Thor formulations currently on the market, and the cost of authorisation could be up to £15million. All biocidal products placed on the market would have to be authorised and annual fees were likely for maintaining the authorisations. There was also a cost for mutual recognition.
The BPD had been law since 2000, with transitional arrangements to allow nonauthorised existing biocidal products to remain in the market. However, when a biocidal active was included in Annex 1 for a Product Type, then dossiers for biocidal products containing the active for that Product Type must be submitted for authorisation within two years, and authorisation and mutual recognition must be completed within a further two years. The product was then placed in the Register of Biocidal Products, with authorisations normally lasting ten years.
Enforcement of the BPD was through the National Competent Authority (eg. Health & Safety Executive in the UK) and for label claims through the UK Trading Standards. Many EU Member States had their own existing registration scheme, which could be used to check on authorisations. Informally the industry would have some input with respect to the use of non-registered actives.
Turning to the BPR, Dr Seal said that the new Regulation, due for publication in September 2013, replaced the BPD and had some transitional arrangements. It contained new requirements, namely:
• ‘Treated Articles’
• In-situ generated biocides
• Exclusion criteria
• Dual use
• Union authorisation
• ‘Family’ product authorisation
• Free rider issue
• Parallel trade
A treated article was defined as “any substance, mixture, or article which has been treated with, or intentionally incorporates, one or more biocidal products.” The article label must provide the following information:
• Statement that the treated article incorporates biocidal products
• The biocidal property of the treated article
• The name of all active substances in the biocidal products
• Instructions for use/precautions because of the biocidal products it incorporates – if this is necessary to protect humans and the environment
• Free consumer information within 45 days
A treated article that has a primary biocidal function shall be considered a biocidal product. Biocidal products that may have a dual use, or example in connection with medical devices, must comply with the BPR and the Medical Devices Directive.
Union authorisation will involve single authorisation to remove the need for the mutual-recognition procedure. This would be administered by the European Chemicals Agency (ECHA) but there would be no union authorisation for products containing substances of concern.
Family product authorisation will replace the Frame formulation concept, making it more flexible, covering variations in concentration of the biocide in different products and also products with:
• Similar use (Product Type)
• Same active substances
• Same/less risk when changing non-active substances
• No significant reduction in efficacy
Family product authorisation was expected to decrease the number of authorisations by two thirds and significantly decrease the cost.
Dr Seal pointed out that, under the BPR, all manufacturers wishing to place an active biocidal substance on the market (including imports) must provide ECHA with a copy of the submitted dossier, or a letter of access to the dossier, by September 1, 2013. ECHA will compile a list of manufacturers/importers, and anyone not on that list will not be able to offer their active substance for use in a biocidal product after September 1, 2015. This procedure will stop non-evaluated actives from being used.
For the future, Dr Seal considered that there would be action to introduce:
• Responsible use:
- training to professionals
- point of sale information
- adverse incident reporting
- recycling
• Authority National Action Plans
• Incentives for technologies that prevent misuse, reduce accidents and risk (accelerated reviews, longer approvals)
• Obligation on authorities to act against illegal products and illegal use
• Best practice information on all labels and in advertising, responsible uses in sensitive areas
Antimicrobial Activity, Testing and Selection
Bacteria and fungi can cause deterioration in textiles, which can lead to a loss in physical performance and ageing, as well as unsightly staining, unpleasant odours and potential skin infections caused by fungal growth. Bacteriostatic and bacteriocidal agents are used in the textile industry, the main differences between these types of agents being illustrated in Table 1.
Many antimicrobial treatments are essentially bacteriocidal and, because of their leaching action, need to be evaluated for their health and environmental effects. Many of the latest developments tend to favour bacteriostatic agents because these are of lower risk.
In selecting antimicrobial agents, it is important to select products from within the BPD, but testing is required to evaluate the antimicrobial effect on the textile, as well as ensuring that there is no loss in the overall performance characteristics of the textile material. Antimicrobial performance needs to be substantiated, otherwise exaggerated product claims could result in challenges. The long-term effects, especially of bacteriostatic agents, need to be considered because of the possibility that this type of agent could promote the growth of micro-organisms that develop resistance to the agents themselves.
The testing of antibacterial agents can be assessed via relatively quick qualitative visual-assessment tests, or by longer tests that are quantitative and may include ‘challenge testing’. In such tests a comparison is made between treated/untreated samples of the textile material. Quantitative tests are assessed as a comparative count of ‘colony forming units’ (cfu). Some tests that are available for the assessment of antibacterial agents are illustrated in Table 2.
Fungi on textiles can give rise to the growth of moulds or mildew, production of musty odours, and biodeterioration of the textile (ie. rotting). Antifungal agents can be assessed using a relatively rapid visual assessment to establish whether antifungal action is present. Longer quantitative test methods expose the textile material to fungal action, eg. under soil burial conditions. The quantitative tests are generally assessed in terms of the reduction in the physical performance of the exposed textiles. See Table 3.
It is important, in the application of antimicrobial agents such as antibacterial finishes, to understand that unrealistic harsh test conditions or excessive demands upon the service life of the textile (eg. a large number of wash/wear cycles in the projected service life of a treated garment) can lead to overtreatment of the textile. This is an important consideration because overtreatment can exacerbate problems through skin contact during wear, an area in which Regulators will show due concern.