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Delegated Legislation Committee Debates

Dangerous Substances and Preparations (Nickel) (Safety) Regulations 2000

First Standing Committee on Delegated Legislation

Wednesday 25 October 2000

[Mrs. Ray Michie in the Chair]

Dangerous Substances and Preparations (Nickel) (Safety) Regulations 2000

4.30 pm

Mr. Nick Gibb (Bognor Regis and Littlehampton): I beg to move,

    That the Committee has considered the Dangerous Substances and Preparations (Nickel) (Safety) Regulations 2000 (S.I. 2000, No. 1668)

The Opposition requested today's debate on these regulations, which are yet another example of the thousands of regulations that pass through this House as a consequence of European Union directives. The relevant directive in this case arises as a result of the single market legislation. The pressure for the change in the law that the regulations introduce came not from Members of Parliament who had been lobbied by their constituents, but from civil servants in Denmark and Sweden, who lobbied civil servants in Brussels.

The regulations effectively ban the use of nickel in jewellery that is used in pierced ears and other parts of the body immediately after the piercing has taken place. Ten per cent. of women and 2 per cent. of men are allergic to nickel, most of whom can tell that they are allergic from a tingling sensation that they experience on coming into contact with the metal. A small minority, estimated at about 0.5 per cent. of the population, experience a more severe reaction: a rash on immediate contact with the metal.

As a general principle, it is excessive to ban a substance that is not of itself life-threatening or severely damaging to people, not even to a minority of the population. There are many examples of substances that are life-threatening to larger minorities, such as peanuts, which we would never dream of banning—nor should we.

According to the Government's figures in the regulatory impact assessment, the regulations will add £10 million to £20 million per annum to business costs in this country—and we all know that regulatory impact assessments underestimate such figures. The regulations are a classic example of the avalanche of new regulations that are pouring like a torrent on to United Kingdom business. They comprise just four regulations that apply only to a small segment of UK industry— principally the cosmetic industry—yet they will add £20 million a year or more to industry costs. The Government—especially the Department of Trade and Industry—and Members of Parliament need to be much more vigilant and aggressive in resisting such measures. The cumulative effect is reaching a point where it is strangling business and undermining people's respect for the law.

I turn to some specifics. Regulation 3 is the key regulation.

Mr. Michael Jack (Fylde): I should like to take my hon. Friend back to the beginning of his speech, when he said that the reason for the regulations was lobbying. Does he have any evidence as to whether such lobbying was the subject of consideration by the Council of Ministers?

Mr. Gibb: My right hon. Friend makes a valuable point. I hope that the Minister will set out what meetings and representations he and his Department have made to Directorates-General III at the European Commission, from whence the regulations emanated.

Regulation 3(1) makes it an offence to

    supply any post assembly intended to be inserted into a pierced ear or other pierced part of the human body during epithelization of the wound caused by such piercing...if that post assembly contains nickel or a nickel compound, unless the post assembly is homogeneous and the concentration of nickel which it contains is less than 0.05 per cent.

Could the Minister define ``homogeneous'' for the purposes of the regulations? According to the industry, it is not possible to construct a homogeneous post assembly; they are almost always made up of components that are then welded or put together in some other way. There is also concern that the period of epithelisation has not been specified. Could the Minister provide some indication of what period he would expect this to cover? It is an important point because the rules for the post-epithelisation period are much less draconian and extreme than those that apply during epithelisation.

The biggest concern about these provisions relates to high-grade surgical quality stainless steel, such as 316L as it is known in the business. Such compounds contain 12 to 18 per cent. nickel but do not release any nickel ions. These high-grade stainless steels are used in surgical implants that remain in the body for life. 316L is known for its strength and high corrosion resistance. Under this regulation and directive, such material cannot be used for piercing post assemblies because it contains between 12 and 18 per cent. nickel as against the 0.05 per cent. permitted in the regulations. That is absurd. This compound does not leak nickel ions, so where is the harm in using this form of high-grade stainless steel?

Stainless steel is generally a compound of carbon, manganese, phosphorus, sulphur, silicon, chromium and nickel and before these regulations were introduced, post assemblies were generally of stainless steel type 303, a quality not as high as 316L. The industry was therefore keen to upgrade to that better quality stainless steel, but because of the regulations it has had to revert to inferior substances such as copper-based plated brass, the long-term consequences of which are completely unknown. Other potential substances to which it must resort are palladium or cobalt. Quite a bit of academic evidence shows that exposure to palladium may well be a problem to people who are allergic to nickel. In a few years' time, therefore, we shall have to go through the process all over again to deal with palladium.

It may be that when the directive began its life nearly 10 years ago, as a result of legislation in Denmark, stainless steel of the quality of 316L was at an early stage of development. Now that it is fully developed and in general use for surgical purposes, it is absurd that the directive has not been amended. It is equally absurd that the regulations that we are debating today do not include an exception for this compound, notwithstanding the risk that the Minister would face of infraction proceedings. That is the view of the Minister's Department, which wrote to Mr. Paul Glynn at DGIII on 2 May 2000.

The letter says that the main area of concern is the restriction on the content of nickel in post assemblies for pierced ears and other pierced body parts to less than 0.05 per cent. Current high-grade stainless steel, which may contain up to 38 per cent. nickel, is permitted for use as an implant by the medical profession under a different legislative regime. However, under the terms of the directive, stainless steel post assemblies will not be allowed for use in body piercing. It does appear anomalous that on one hand the medical profession can use stainless steel implants on the human body yet the consumer will be unable to choose that option for body piercing. The letter adds that the nickel content of stainless steel is fused in such a way that the nickel cannot be released into the body and if that is the case there would seem to be a reasonable argument to amend the directive to allow these products to be used for piercing during epithelisation of the wound.

In addition to Britain, a number of other European Union member countries have written to Paul Glynn at DGIII begging him to amend the directive. They include Ireland, which makes an additional and valid point in its letter. It says:

    There is concern that consumers, faced with the significant additional cost that this will impose, will seek alternative approaches to piercing such as self-piercing, using unsuitable materials, or will turn to less reputable individuals who will be prepared to ignore the provisions of the Directive.

The Minister for Competition and Consumer Affairs (Dr. Kim Howells): We have written to the Commission, in support of Ireland and a number of other member states, to ask for the directive to be reviewed regarding surgical steels, but it has not dealt with that yet. It is also aware of the problems with the rigour of the testing of spectacle frames.

Mr. Gibb: I am grateful to the Minister for his intervention. However, he has just admitted that there are problems with the regulations, so why has he placed them before the Committee and the House to be passed into United Kingdom law? It is not only the British and Irish Governments who hold that view; the Dutch, Belgian and Finnish Governments have written to the Commission in a similar vein to seek an amendment to the directive. Given that level of opposition, I cannot understand why the Commission has not amended the directive.

Perhaps the Minister can explain why the EU is resisting an amendment. Given the level of support and the overwhelming case made by the industry, why has he not provided for an exemption in the regulations? I cannot understand why they have come here in the first place, but as they have, why has he not inserted an amendment that allows an exemption for high-grade stainless steel? What representations has the Minister made to Mr. Glynn, and has he taken the trouble to meet anyone from the Commission?

We seem to be in the odd position of being asked to pass a measure with which even the Government do not agree, without even the debate in Parliament that would have taken place had the Opposition not prayed against the regulations. That is the meat of the industry's concern.

If the Minister insists on using the Government's majority to push the measure through—despite his own Department's opposition—a number of other issues must be clarified. The first is the type of tests required under the regulations. There are three principal requirements. The first concerns assemblies used in pierced ears and so on for the three to six week epithelisation period. The rule is: no more than 0.05 per cent. nickel.

The second requirement concerns jewellery used after the piercing has healed and any product intended to come into

    direct and prolonged contact with the skin.

In those circumstances, the rate of nickel release must be less than 0.5 (g per sq cm per week.

The third rule also concerns products that have direct and prolonged contact with the skin, but which have a non-nickel coating. Again, the rule is that the nickel release must not exceed 0.5 (g per sq cm per week for at least two years of ``normal use'', which is difficult to define. For the purposes of the regulations, the product—or at least a sample of it—must be tested in accordance with BS EN 12472, which is known as a release and wear test. It involves a mechanical simulation of two years' wear and tear, which slowly grinds off the non-nickel coating. That test costs about £50, but some products in the industry have a very low cost-35p is typical. The industry is fast changing and fashion-conscious: an importer may have to test about 5,000 different styles in a 12-month period.

A much cheaper quick test has been developed, known as the dimethylglixine test—I think that the Minister would prefer to call it DMG, as I would. Why has he not allowed that test to be used, instead of insisting on BS EN 12472? Will the Minister tell us what he understands by ``direct and prolonged''?

Could he give some examples that illustrate those terms—other than my speech? some might think that 30 minutes is a suitable definition of prolonged contact, which would include umbrella handles if one were out in the rain for more than 30 minutes, a pen or mobile phone cases. Will those products be included within the provisions of the regulations?

Would spectacle frames—to which the Minister has referred—be included in the provisions? The tests destroy the product and that would involve the spectacle frame industry in great expense. So many designs fall within the provisions. The Italians have specifically excluded spectacle frames from their regulations; I imagine that they are not afraid of infraction proceedings. Could not such an exclusion be introduced into the regulations? Alternatively, the Minister could confirm that there is no intention to include them—although I am not sure how much weight such a statement would carry since I do not know whether Pepper v. Hart constitutes a precedent for the European Court of Justice.

The next area of concern relates to second-hand goods. It is often not possible to tell when such goods were manufactured and thus to know whether it was before the 20 January 2000 deadline. That will increasingly become a problem. There is also the issue of testing since the required test destroys the items. Importers can test a batch or sample of new products but such an approach is unworkable for one-off second-hand goods, which are often valuable because they have acquired the status of antiques. In a letter to such a trader on 28 January, the Minister's Department said that second-hand goods were not covered by the regulations, which seems sensible. However, in a subsequent letter written in May, the same official wrote to the same trader:

    In my letter of 28th January, I informed you that second hand goods were not covered by the Regulations. Although correct at that time, subsequently I have discovered that second hand goods are not specifically excluded from the Nickel regulations... I apologise for the contradictory information but the Legal Branch of the DTI, who have drafted the Regulations, has only recently reconsidered this point.

So, there we are: confusion. Will the Minister clarify his position on second-hand goods?


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