The Biocidal Products Directive (BPD) 98/8/EC

The Directive has three main objectives:

1. To harmonise the European market for biocidal products and their active substances
2. To provide a high level of protection for people, animals and the environment related to the use of biocidal products through risk assessment. This requires the submission and evaluation of data relating to substances’ chemistry and their toxicity to humans and the environment
3. To ensure products are sufficiently effective against the target species

Under the BPD biocidal products are 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.'

The bold words and phrases are further defined below:

'Active substance' - 'a substance or micro-organism having a general or specific action on or against harmful organisms'

'Harmful organism' - 'an organism which has an unwanted presence or a detrimental effect for humans, their activities or the products they use or produce, or for animals or for the environment'

'Chemical means' - ' A substance controlling harmful organisms is regarded as an active substance acting by chemical means when the control is linked to the interference of that substance in biological/physiological processes through direct chemical interaction (inside or outside the target organisms) or indirect modifications because of the physical/chemical properties of the substance (chemical means)'

'Biological means' - ’A substance controlling harmful organisms is considered as an active substance acting by biological means when the control action directly involves living micro-organisms (biological means)'

As the scope of the BPD is very wide, it is further defined by four main categories:

1. Disinfectants – for home and industrial use
2. Preservatives – for natural and manufactured products
3. Pest control products
4. Other biocidal products

The BPD achieves its aims using a two-stage process involving rigorous evaluation of both biocidal active substances and biocidal products, to ensure they pose no unacceptable risks to people, animals or the environment.

Ultimately, only those biocidal products, which contain an active substance, which is included in Annex I of the BPD, will be authorised for use. Active substances have to be evaluated to determine whether they will be included in Annex I. This requires industry to submit data that is evaluated by Member States with decisions over Annex I inclusion being taken at the European level

Once an active substance has been included in Annex I, Member States can authorise products containing it in individual Member States (providing that any necessary data has been supplied and any conditions put on Annex I inclusion are met). Once a product has been authorised in the first Member State of the EU, it will be possible for it to be mutually recognised and therefore authorised by other Member States.

Timescales for this process vary depending upon the active substance and the workload for the Competent Authority (Member State organisation) responsible for Registration under Annex 1.

Allied Hygiene is preparing files for submission of formulas in the disinfectant category. All the ingredients of its formulas comply with all products within Annex 1 including its preservatives.

For disinfectant formulas falling within Allied’s disinfectant wipes range, the current timescales for registration of the actives under Annex 1 are 2014 – 2015 and subsequently for the registration, evaluation and authorisation of formulas containing these actives 2016 – 2017.

Updates on these timeframes and Allied’s progress in this area will be communicated at the appropriate time.