REGULATORY FRAMEWORKS
An example of this is that in the EU there are many potential areas that overlap between medical devices, medicines, cosmetics, and what are determined to be biocides. In many cases this leaves companies unsure of which framework to register their products in, or, in some cases, registering in all four regulatory pathways. In addition, it is difficult to understand the need for the recently introduced Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH EC 1907/2006) regulations which, given that the Biocides Product Directive (BPD)1 Product Regulations (BPR)2
(now the Biocides ) have already
been working to register chemicals for years, it seems to make the REACH introduction completely unnecessary. The REACH regulations were recently described by the EU as “the most complex piece of legislation in the history of the EU.”
These regulations are so obscure, poorly devised, poorly written, and are so difficult to interpret, that an entire new business model has emerged. Many people who previously worked as regulators, now work in companies that charge to advise manufacturers which regulations apply to their products, and how to ensure they pass through the relevant regulatory frameworks. There are even cases where a regulator has been asked for a view or advice on a particular product type, the regulator then advised the manufacturer that they should contact a private company (by name) to help them through the process! In addition, government regulators suggest that companies gain accreditation of systems from other private companies such as BSI/ISO. Companies such as VW have a number of ISO accreditations relevant to their industry, including ISO 14001. Unfortunately, it did not stop them from falsifying the exhaust emissions and fuel consumption figures. Little wonder then that many companies feel aggrieved at being herded towards using them. A recent significant extra cost to the chemical industry is the individual country registration of a biocide that is already on the central EU register of biocides. If a biocide is already registered (and has therefore passed through the EU regulators) and the chemical components are already well known, and have been declared safe in use, why should they need to be re-registered? If already registered, the product must have been in use in the market for - in some cases - a
considerable amount of time. It would therefore seem ridiculous that the costs of registration in each individual country can be in the region of £250,000 to £500,000 - dependent on how many uses the product has (every product needs to be registered for every use). If this strategy is intended to protect companies that have already registered a chemical product for use, then in effect the is the EU regulator is acting as a type of patent office.
By taking massive fees to ensure large chemical companies are not undercut by newer, smaller companies selling the same chemicals, the regulators are interfering with market competition, which naturally benefits only the very large companies who can easily afford the charges. Clearly, acting as a protectionist office for large companies isn’t the job of a regulator, as it has nothing to do with product safety, or efficacy, and a lot to do with large companies keeping out competition. That type of protection is surely the jurisdiction of the patent office, with all individual country courts able to ensure chemicals are protected under the current patent laws. If a chemical isn’t patented, or is out of patent, then it is not protected, and is then free to be sold on the open market by whoever can manufacture it safely.
Until 1 September 2013, when the BPD1 was replaced by the BPR,2
there was no
Many people who previously worked as regulators, now work in companies that charge to advise manufacturers which regulations apply to their products, and how to ensure they pass through the relevant regulatory frameworks.
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requirement to re-register products with the same chemical composition. Once a registration had been accepted by any country or the central EU regulators, it was an automatic pass through the system at low cost for any other company. In some respects, changing the system to the BPR was a stroke of genius by EU regulators, and the European Commission. All companies were forced to re-register their products, paying a new fee for each registration for each intended use, with 22 potential categories within in which to register the 7000 plus products on the BPD. This was a massive revenue generator. For new products, it is a similar system, where a company would have previously pointed out a current registration and safety certificate for a product, under the new system every filing has to be completed by every company for every intended use. This is potentially a massive cost to a company when preparing the documents and evidence required, plus in some pathways, each of these filings attracts a new fee. If this were income tax, it would be referred to as a “windfall tax.”
There are, of course, other problems with this change. Most of the work on registration/re-registration of the chemicals from the BPD to the BPR is currently being done in Helsinki, with some specialist areas being reviewed in Italy. The entire new pathway, with every product fully registered, was due to be completed by 2018, however, it is not even close to completion with the registration of wood preservatives being chosen to be completed first. In fact, inside sources say it will take at least another five to eight years to complete the registration work, just on the current products. It is difficult to imagine that no new products will be applying for registration over the next five to eight years, so this timeline can be extended still further.
OCTOBER 2019
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