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Biocidal Products Regulation Part 1: History & Legal Framework

Biocidal Products Regulations

The Biocidal Products Regulation (BPR, Regulation (EU) 528/2012) is one of the most seismic pieces of legislation to affect the chemical industry in decades. In this five part technical series, we examine key aspects of the legislation, where it originated from and its impact on the industry.

BPR aimed at improving the marketing and use of biocidal products used to protect humans, animals, materials or articles against harmful organisms like pests or bacteria/viruses by the action of “Active Substances” (ingredients) contained in the biocidal product mixture; ensuring a high level of protection for humans and the environment.

Regulatory History & Intentions

A system intended to create a level playing field for the supply of disinfectant products across the EU came into effect 20 years ago with the grand title Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market.

This was quickly shortened to the Biocidal Products Directive (BPD) with the original aims of the legislation being considered reasonable by most observers.

BPD sought to create a regulatory structure that allowed biocidal products (and the active ingredients within the products) to be assessed to show that they were effective whilst offering a high level of protection to people using the products and to the environment.

Prior to BPD being introduced, there was strong political and consumer pressure to control the use and supply of biocidal products. Each member state had its own set of national rules for the supply of biocidal products ranging from simple notification schemes with few restrictions to more heavily regulated systems as used in the Netherlands for example.

There was growing evidence that some of the biocidal products on the market had unintended side-effects on the health of end-users and the environment.

The patchwork of different regulatory systems across EU member countries acted as an impediment to free trade. One EU state could outlaw the import of biocidal products from another because the products did not comply with local regulations.

BBD: The Application of Common Rules

BPD sought to create a common set of rules that could be applied to all biocidal products sold in the EU, restricting use of the most dangerous biocides, outlawing the very worst. It was argued that a common set of rules, applied to all countries, would be fair, prevent trade restrictions between member states and curb uncontrolled pollution.

So BPD was initiated with good intentions; introducing controls, forcing suppliers of biocidal products to take responsibility for their products and encouraging manufacturers to create safer disinfectants in a way that allowed free trade across the EU.

As with much legislation, however, the devil is in the detail. Some aspects of BPD soon became unworkable.

As a result, BPD morphed into BPR (Biocidal Products Regulations) in 2012 but concerns remain within the industry that some of the original aims of BPD have been lost along the way with the process taking much longer than intended, imposing a compliance cost burden which restricts new product development and ultimately consumer choice.

Part of the problem arose from how a biocide was defined in the legislation and the sheer number of different product types that fell within the scope of BPD.

Biocidal Products Regulations

Defining the Term “Biocide”

Even in the early days of BPD, problems were anticipated with implementation of the legislation. There were difficulties arising from the way in which a biocide was defined. Issues also arose with the regulatory hierarchy with some products falling into several different product categories, each with its own set of regulations.

For example, should a liquid soap used to sanitise (clean & disinfect) your hands be governed by BPD or by Cosmetic Regulations as the product is used on skin? Depending on why the soap is being used, it could even be considered a medicinal product.

Biocidal Products Regulations

We examine this quandary later in the series, but for now, let’s start by looking at how a biocide is defined. BPD Article 2.1 defined a biocide 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 above sentence is unlikely to win awards from the organisers of the Plain English Campaign but let’s take a moment to examine some of the key wording.

“…substances and preparations containing one or more active substances…”

This means that BPD applied to both biocidal products supplied to customers, such as disinfectants and sanitisers, and the individual ingredients within the mixture that provide biocidal properties.

“…intended to destroy, deter, render harmless, prevent the action of, or otherwise exert a controlling effect on any harmful organism…”

This is an important phrase as it raises two keys issues:

  1. A biocidal product does not need to totally eradicate nasty bugs. If it merely deters bacterial growth or inhibits the multiplication or impact of harmful organisms, the product was considered to be within the scope of BPD.
  2. An important feature of the legislation is the intention of the person placing the product on the market. If the product does not make any claims to have an impact on harmful organisms, then by implication it is not a biocidal product as defined by BPD.

An example of this is alcohol. Alcohol has long been known to kill bacteria, but a bottle of whisky, containing 40% alcohol, is sold as a drink and is not intended to be used as a disinfectant.

There are hundreds of products in everyday use that inhibit the spread of harmful organisms, but these products would only be subject to biocidal product legislation if there is a specific or implied claim of biocidal activity on the product labelling or in related marketing or advertising of the product.

“…by chemical or biological means…”

Essentially excludes products that kill harmful organisms by physical or mechanical action, and only by chemical or biological means. So a chemical product used in the manufacture of bait for killing mice falls within the scope of the biocide legislation, whereas the mouse trap would not.

The Resulting Categorisation: Product Types (PTs)

When BPD came into force on the 13th May 2000, 23 different types of biocide were described across four main groups.

We will examine this in more detail in Post 3, but biocidal products supplied by the cleaning industry fall mainly into Group 1 – Disinfectants & General Biocidal Products including human hygiene; private area and public health; food, feed and drinking water disinfectants.

But the legislation extends to some more esoteric products, including:

  • PT9: Fibre, leather, rubber and polymerised materials preservatives.
  • PT15: Products used for the control of birds, by means other than repulsion or attraction.
  • PT22: Embalming or taxidermist fluids.

So faced with so many diverse chemicals to assess and control, across a growing number of EU member states, it may have been predictable that the timescale envisaged to fully adopt the legislation would start to slide and the primary legislation itself would have to be revisited.

In part two of this series we examine the move from BPD (Directive) to BPR (Regulation); how the legal process had to be streamlined and achievable to avoid further delays.

The Arpal Group

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