Technical Barriers to Trade in the absence of a Mutual Recognition Agreement

Before continuing to examine the possible outlines of a post-Brexit Mutual Recognition Agreement on conformity assessment for products traded with the European Union, it occurs to me that it would be appropriate, and indeed logically prior, to consider what the situation would be without any such agreement. I have seen very different estimations of the extent of the problem of Technical Barriers to Trade in the absence of any such agreement. On the one hand, in Flexcit, Richard North has warned (p. 69, referring also to barriers related to Sanitary measures for trade in animal products) that in the absence of such MRAs the UK would:

have considerable difficulty in securing uninterrupted trade flows… In fact, this is something of an understatement. Shippers presenting goods to the customs authorities at entry points to the EU (or EEA members) will find that they no longer have valid certification documentation, without which loads will be refused entry. The option is either to return the load to the point of origin or to agree to its detention pending the procurement of valid certification….

the delays are highly damaging. Many European industries are highly integrated, relying on components shipped from multiple countries right across Europe, working to a “just in time” regime. If even a small number of consignments are delayed, the system starts to snarl up.

… As European ports buckled under the unexpected burden of thousands of inspections and a backlog of testing, a huge range of loads would build up while test results and clearance was awaited. The system would grind to a halt. It would not just slow down. It would stop…

The problem would be exacerbated by the system in force for products of animal origin. …

In all respects, therefore, a strategy based on an expectation that Britain can rely solely on WTO rules, without securing any direct agreements with the EU – and in particular without securing an MRA on conformity assessment, would not be well founded. Britain would struggle to maintain its current levels of external trade and there would be a profound adverse effect on daily life and employment. Far from a potential three million job losses, with the knock-on effects to UK production, that number could easily double and then be exceeded by a substantial margin.

On the other, Keith Armstrong, a leading expert in electromagnetic compatibility (EMC), and among other things a Senior Member of the IEEE (Institute of Electrical and Electronics Engineers), wrote in In Compliance Magazine (whose sphere of interest is regulatory compliance) in 2013 in an article about the EU’s EMC Directive:

Compliance with the EMCD certainly does not require any test reports from third-party EMC test labs. This is what makes it possible for many manufacturers of electronic products around the world to save time and money by testing in their own EMC labs.

This also makes it possible for individual entrepreneurs, who might be working out of their garages (like Mr Hewlett and Mr Packard did when they first started) to sell their products in the EU without the high costs associated with EMC testing to standards.

In fact, the same is true for most of the so-called CE Marking Directives – third-party testing is only a legal requirement in a very few EU Directives, and only then when dealing with especially dangerous products, e.g. certain kinds of medical equipment; especially dangerous machinery such as chainsaws, bandsaws, etc.

I have often heard the EU’s single market described in the USA as Fortress Europe – when the exact opposite has always been true: the EU’s single market does not present any significant barriers of cost or delay to any equipment from anyone, anywhere.

Who is right? Richard North warns that more than six million jobs could be lost, while Keith Armstrong considers the barriers to the EU’s single market to be insignificant. To resolve the matter requires first of all an understanding of:

a) The nature of the rules and regulations that products supplied to market in the European Union have to adhere to;

b) The methods employed to assess and establish conformity with these requirements.

By and large, these conditions apply to all manufacturers of products and suppliers of goods, whether established in the EU or not. Then in addition, one needs to consider:

c) Any extra requirements faced by exporters to the EU.

As a matter of convention, rules for food safety and for animal and plant health and safety, are treated separately from those for other products. They are known as Sanitary and Phytosanitary (SPS) Measures and in the WTO are covered by the SPS Agreement. Those for industrial products are often referred to as Product Safety rules, a term which is generally understood to cover not only rules made to prevent accident, but also those designed to protect health, the environment and the consumer more generally, this combination of objectives sometimes being referred to accordingly as SHEC (see Article 114(3), TFEU). It has been commented that:

the vast domain of regulations and standards justified by SHEC, that is, safety, health, environment and consumer protection [is] … quantitatively, by far the most sizeable segment of regulation in modern economies. 1

In the WTO, Product Safety rules and regulations are covered by the Technical Barriers to Trade (TBT) Agreement. It may be worth commenting that SPS measures can constitute trade barriers just as much as can Product Safety measures. If, for the sake of relative brevity and simplicity, I confine myself mainly to TBTs in this post, it is not to discount the potential importance also of SPS measures as a factor in post-Brexit trading relationships.

The Old Approach and the New Approach

The traditional approach to product legislation in the EU, known as the Old Approach, was simply to write detailed regulations containing all the necessary technical and administrative requirements for each type of product. 2 This reflected the existing national approach to product legislation. 3 This approach is still employed for foodstuffs, biocides, motor vehicles, chemicals, cosmetics, detergents and pharmaceutical products.

The New Approach, which was launched formally in 1985 through Council Decision 85/C 136/01:

New Approach Council 1985

is built upon a combination of EU Directives or Regulations, which set rather general safety objectives for a broad sector or family of products, or type of hazard, and detailed harmonised standards developed by the European standards organisations, CEN, CENELEC and ETSI, which are published in the EC Official Journal and transposed without change into the national standards. 4 One of the remarkable features of this system is that a manufacturer is not actually obliged to meet these published European standards, but only to meet the ‘essential requirements’ set in the relevant Directive or Regulation. But if these standards are used, then this is said in the text of the Directive or Regulation to give a presumption of conformity with the essential requirements. As explained in the above-mentioned Council Resolution of 7 May 1985:

This signifies that the producer has the choice of not manufacturing in conformity with the standards but that in this event he has an obligation to prove that his products conform to the essential requirements of the Directive. 5

The intention of the Commission was to ‘halt the proliferation of excessively technical separate Directives for each product.’ 6 The work of technical harmonisation, which had been found to be very slow and difficult at the political level, was transferred to the technical European standardisation organisations.

It should not be thought, however, that the ‘essential requirements’ set in the Directives were only to be rather vague statements of intent. Rather, they were to be:

worded precisely enough in order to create, on transposition into national law, legally binding obligations which can be enforced. 7

If the essential requirements were met by a product, then it could be marketed freely in the Community, and no Member State could refuse it entry on technical grounds. 8

At that time, 1985, most of the technical harmonisation that had been accomplished thus far under in manufacturing industry had been in three sectors: motor vehicles, metrology and electrical equipment. 9 It was decided not to call into question those Old Approach regulations that were already advanced, notable those for motor vehicles, but to concentrate the New Approach on other sectors. However, the situation with regard to electrical equipment was different, since this was the one area which had been tackled already by a ‘general reference to standards’ type of Directive (Low Voltage Directive, 73/23/EEC) 10, the standards being those of the International Commission on the Rules for the Approval of Electrical Equipment (CEE), and of the International Electrotechnical Commission (IEC). 11

Personal Protective Equipment

One of the early New Approach Directives covered the area of Personal Protective Equipment (PPE). 12 PPE Directive 89/686/EEC is still in force today, although in the process of being replaced by Regulation (EU) 2016/425. In the Preamble to the Directive, it is pointed out that with regard to existing national legislation in this area:

these national provisions are often very detailed as regards the requirements relating to the design, manufacture, quality level, testing and certification of personal protective equipment with a view to the protection of individuals against injury and illness; 13

and that:

national provisions relating to personal protective equipment differ significantly from one Member State to another; … [and] may thus constitute a barrier to trade with direct consequences for the creation and operation of the common market;

so that:

it is necessary to harmonize these different national provisions in order to ensure the free movement of these products, without in any way reducing the valid levels of protection already required in the Member States…

With regard to ‘free movement’, Article 4(1) states that:

Member States shall not prohibit, restrict or hinder the placing on the market of PPE or PPE components which satisfy the provisions of this Directive and which bear the EC mark .

The EC mark (the ‘CE’ Mark, the initials standing for Conformité Européene) is (see Article 12) a visible mark on the product (or its packaging) which accompanies a declaration by the manufacturer that the product is in conformity with the provisions of the Directive. It is to be accompanied (Annex IV) by the year in which the mark is fixed:

CE mark 89

For equipment, commonly referred to as ‘Category I’, such as gardening and washing-up gloves, and sunglasses of the ordinary sort, for which (Article 8(3)) the ‘the user can himself assess the level of protection provided against the minimal risks concerned’ and whose effects ‘when they are gradual, can be safely identified by the user in good time’, no third party assessment is required.

All other PPE must be submitted (Article 10) to a third party ‘approved inspection body’, otherwise known as a ‘Notified Body’, for ‘EC type-examination’, the word ‘type’ signifying that not every individual product has to be examined but only an ‘appropriate number’ of specimens of the model in question. Category III PPE, including those ‘intended to protect against mortal danger’, and among which are motor-cycle helmets, certain types of breathing equipment, suits to protect against chemical attack or radiation, and equipment to protect against falls from a height, is also subject to checks (Article 11) by a Notified Body that the final manufactured product is in conformity with the type that has been examined and authorised.

The ‘essential requirements’ are given in Annex II. Some of them are startling in their simplicity. For example (Annex II, 3.1.2.1), ‘The outsoles for footwear designed to prevent slipping’:

must be so designed, manufactured or equipped with added elements as to ensure satisfactory adhesion by grip and friction having regard to the nature or state of the surface.

That’s it. The essential requirements for ‘PPE designed to prevent falls from a height or their effects’ (Annex II, 3.1.2.2) are a little more involved and show moreover, at least to my mind, evidence of being the outcome of careful thought, as of course one might expect:

PPE falls 1

PPE falls 2

Each Member State (Article 9) is to inform the other Member States and the Commission of the bodies it has approved to carry out conformity assessment of Category II and III PPE:

PPE Notified bodies 1

PPE NB 2

The criteria for approval of these product conformity assessment bodies are laid out simply and clearly in Annex V:

PPE criteria

Reference to the harmonised standards is in Article 5, and relates only to Category II and III  PPE. If the Notified Body (Article 5(2)) has certified that the product is in conformity with the harmonised standards, transposed into the national standards, then the Member States shall ‘presume’ that it meets the essential requirements. Where the standards have not been employed in full, it is for the notified body to determine whether the product nevertheless satisfies the basic requirements of the legislation. If it does, then a certificate of conformity may still be issued:

PPE presumption

The references to the harmonised standards for PPE can be found on the Commission’s web-site.

Anti-slip footwear

Highly relevant to footwear designed to prevent slipping, whose essential requirements were given above, is EN ISO 13287:2012, which gives a standard test method for testing such footwear:

standards

slip

This particular standard is identical to the ISO standard on the same subject, and in fact was the result of a collaboration between the relevant CEN and ISO Technical Committees, in accordance with the Vienna Agreement on technical cooperation between ISO and CEN. It is also identical to the transposed British standard BS EN ISO 13287:2007. As one would expect, it contains diagrams:

PPE foot slip diagram

and detailed instructions including, for example, for the heel test shown above:

heel test

It is a simple test, with a vertical force applied to represent the weight of the person, a horizontal force to cause slippage, and measurement of the resistance given by the shoe. The actual slip resistances required are specified in the standards for safety, protective and occupational footwear, in EN ISO 20345:2011, EN ISO 20346:2014, and EN ISO 20347:2012:

feet

One Notified Body that which states a capability to test and certify such footwear according to these same three standards is BSI Group:

BSI footwear compliance

Is EN ISO 13287:2012 reliable?

Having chosen the standard for testing the slip resistance of footwear merely as an illustration of the way that the New Approach legislation works, I was surprised to find that there is strong evidence that the test does not work as a reliable indicator of the safety of footwear, so much so that the British Health and Safety Laboratory does not use it, but rather uses a human-based ramp test. 14 The Health and Safety Laboratory:

has concerns that the mechanical test does not accurately replicate the friction involved in a pedestrian slip, when operated using the values for the test parameters currently in BS EN ISO 13287:2007. HSL uses a human subject-based ramp test method, HSL SOP-12, to assess the slip resistance of both floor surfaces and occupational footwear. This method involves at least two human operators wearing the test footwear and carrying out a series of controlled walks over a standard floor surface, upon which contaminant is applied. The ramp method is effective in discriminating between footwear, and results have proved useful in selecting footwear that reduces the occurrence of slip accidents 15

What is more, the Health and Safety Laboratory has gone as far as instituting its own rating scheme for footwear, called the Grip Scheme, with logo images to display in the manufacturer’s catalogues, to indicate the rating that the product has achieved in the HSL SOP-12 test. It has also been ‘investigating workplace accidents where the injured person was wearing CE marked slip resistant footwear.’ 16

It bears reflection also that slips and trips were the most common cause of ‘major/specified’ injuries in the UK in 2013/4, and accounted for an estimated 986,000 working days lost. 17 It is a matter of concern that the EU’s CE mark on so-called slip-resistant shoes, which is meant to give assurance of safety, may in fact be giving a false assurance, at least in some cases, and notably with regard to wet steel, where the HSL’s test method gives a slip resistance ten times less than that measured using EN ISO 13287:2012 (‘CoF’ is ‘Coefficient of Friction’) 18:

coefficients

Referring to the preceding European Standard, a 2009 HSE study of safety information and literature provided by suppliers observed that:

Slip resistant industrial footwear will normally have been tested for slip resistance according to BS EN 13287:2004 (amended in 2007). However, work carried out by HSL in 2006 to evaluate current test methods used to measure slip resistance, has shown that this test has a lenient pass threshold, raising concerns that this could give a false impression of the suitability of a product. 19

Sunglasses

Sunglasses, as noted above, are an example of Category I PPE, for which there is no requirement for third party testing, but only a manufacturer’s declaration of conformity. CEN standards, again identical to ISO standards, do exist however, both for the requirements and for the means of testing those requirements:

sun

In 2010, scientists at the School of Optometry and Vision Science in the University of New South Wales (UNSW) published a study on the extent to which CE marked sunglasses complied with these European standards. 20 At the time, the Australian standard AS/NZS1967 was technically equivalent to the then current EN1836. The major difference was that the Australian Standard was ‘implemented directly in law with provisions for independent assessment of compliance’. 21 The Optics and Radiometry Laboratory (ORLAB) at UNSW was testing over 1800 pairs of glasses every year for the sunglass importing industry, and some of these were CE marked. The authors became aware that not all CE marked sunglasses were compliant with EN1836.

They then tested 646 CE marked sunglasses for compliance with selected key optical performance requirements of EN 1836, and found that 17% failed to meet the required benchmarks. They realise that it could be ‘argued that failure to comply with EN 1836 is not necessarily failure to meet the EU Personal Protective Eyewear Directive.’ But they counter that:

the nature of the failures (especially matching of transmittance and correct polarisation axes) raise clear safety connotations and are not trivial reasons for failure, so the argument of compliance with the Directive without compliance with EN 1836 seems doomed to fail. 22

Finally, they conclude that:

Self-declaration of compliance appears to be a very blunt instrument in providing appropriate sunglasses for the public.

Again, this raises the question of false assurance. An article in the Daily Mail entitled ‘What to look for in your sunglasses – the complete guide’ advises readers that:

What really counts is the degree to which the lenses filter out harmful UV rays. Look for the CE mark, which proves they conform to the European Community Standard. They should also satisfy British Standard BSEN1836, meaning they will provide high levels of protection against damaging ultraviolet light.

The author is probably conflating the ‘European Standard’ with the EU Directive, and she is wrong to suppose that the CE mark is intended to prove something, rather than only to signify the manufacturer’s declaration that the product is in conformity with the essential requirements of the Directive. Nevertheless, it is surely only natural for the consumer to assume that the CE mark is intended to convey an assurance of safety. If it does not, then why is it there? And if it does not give such an assurance, while consumers are presuming that it does, then are they not being misled?

The EMC Directive

With few exceptions, electrical and electronic products marketed in the EU are require to comply with Electromagnetic Compatibility (EMC) Directive 2014/30/EU, which ‘ensures that electrical and electronic equipment does not generate, or is not affected by, electromagnetic disturbance.’ Remarkably, despite the considerable potential dangers associated with electromagnetic interference (EMI), for example with regard to the malfunctioning of critical equipment, 23 there is no requirement for third party assessment of compliance with the Directive. Instead, the manufacturers need only (Annex II.3, Directive 2014/30/EU) do their own conformity assessment with the essential requirements of the Directive and produce technical documentation to ‘make it possible to assess the apparatus conformity to the relevant requirements’, with ‘an adequate analysis and assessment of the risk(s).’

A series of studies of the level of compliance with the EMC Directive’s predecessor (2004/108/EC) have been undertaken by EMC AdCo, a Working Group of the market surveillance authorities of the Member States. Links to the Reports can be found at the Commission’s AdCo web page (Documents, AdCo Documents). Tim Williams, an EMC expert who has served on the IEE’s EMC Committee, has abstracted the results in the following table:

table

It can be seen that extraordinarily high percentages of products, even up to 67% for solar panel inverters, failed what is perhaps the most important test, that for RF (radio frequency) emissions. In a paper presented to the 2015 IEEE International Symposium on Electromagnetic Compatibility, Nick Wainwright of York EMC Services Ltd draws attention to the same figures and points out that:

Apart from posing risks to users, non-compliance has important economic consequences: It leads to unfair competition. Manufacturers not adhering to the rules can make significant savings on compliance costs by avoiding potentially costly conformity assessment procedures. They can consequently offer their products at lower prices than their competitors who respect the law.

In sectors where there is tough competition from imported low-price products, European industry is disadvantaged. The situation “punishes” the law-abiding manufacturer, as compliance becomes a “competitive disadvantage”. 24

Compliance after Brexit

To what extent would EU product safety legislation be a barrier to British manufacturers exporting to EU Member States after Brexit?

The first simple point to make is that the product safety requirements are the same for all manufacturers whatever their location. It is not as if EU manufacturers are allowed to make less safe products than other manufacturers are. Therefore the physical process of manufacture could continue just as before.

Second, and what is more, the conformity procedure is exactly the same for non-EU manufacturers as it is for those inside the EU. If a manufacturer’s Declaration of Conformity is sufficient, that is true for both groups. If third party assessment by a Notified Body is required, then that also is true for both groups. Once the procedure is complete, both have equal right to affix the CE mark to signify the product’s conformity with the legislation.

As the Commission’s ‘Blue Guide on the implementation of EU product rules’ puts it:

The basic principle of EU product rules is that irrespective of the origins of the products, they need to be compliant with the applicable Union harmonisation legislation when placed on the market. Products manufactured in the EU and products from non EU countries are treated alike. 25

Again (p. 29):

Union harmonisation legislation does not require the manufacturer to be established in the European Union. Thus, when placing a product on the Union market, the responsibilities of a manufacturer are the same whether he is established outside the European Union or in a Member State.

So far as I can see, the main legal difference (with regard to EU product legislation, that is) between the situation of manufacturers inside the EU and those outside, is that those outside cannot put their product on the EU market directly, but have to do so through an ‘importer’, a term that has been brought into recent revisions of the New Approach Directives since the introduction of the New Legislative Framework (NLF) in 2008 (Council Decision 768/2008/EC). 26 But the obligations of importers, laid out in Article R4, Annex I, 768/2008/EC, are not greatly onerous. They are summarised by the Commission as being to to verify that:

the manufacturer outside the EU has taken the necessary steps to allow the product to be placed on the EU market;

the necessary documentation such as the EU Declaration of Conformity and the technical documentation is available upon request;

contact with the manufacturer is possible at any time.

UK companies that currently export to the rest of the EU will most often already have relationships with entities, such as export sales representatives, export management companies, or even their own export sales subsidiaries, which are established in the countries to which they export. No doubt such entities will already in general be ensuring that the products they receive from the UK (known by the EU as ‘arrivals’ rather than ‘imports’) have the appropriate technical documentation, and they are more than likely to be holding copies of the DoC, and to be in easy contact with the manufacturer. They are not (except ‘when deemed appropriate with regard to the risks presented by a product’, Article R4(6), Annex I, 768/2008/EC) obliged to perform any checks on the products themselves, but only to ensure that the more formal requirements are met.

British Notified Bodies

Under the EU product safety legislation, Member States ‘notify the Commission and the other Member States of bodies authorised to carry out third-party conformity assessment tasks’ (Article R4(6), Annex I, 768/2008/EC). The legislation does not say what happens to the status of a Notified Body if the Member State that notified it leaves the EU. Probably it would be a political decision, but it seems to me that in the absence of an agreement between the EU and the UK for mutual recognition of such bodies, their status would at the very least be called into question.

With regard to the Medical Devices Directive (93/42/EEC), which admittedly has some distinctive characteristics, but for which the procedure for notification (Article 16(1)) is much as the same as for the other New Approach Directives, one legal opinion is that:

UK notified bodies would no longer be entitled to conduct a conformity assessment on the basis of the Directives. As a result, manufacturers working with UK notified bodies in relation to the conformity assessment of their medical devices would be required to appoint a new notified body established in an EU Member State. This is likely to lead to a new conformity assessment to permit the continued marketing of their medical devices in the EU.

Personally, I find it hard to believe that products that have already been certified as compliant by a Notified Body would have to be re-tested. But I do think that it is possible, and indeed probable in the absence of an MRA, that for new products conformity assessment would have to be done by a body established in a state that was at that time a member of the EU. What would happen then to the British assessment bodies? Would they lose all their Notified Body work from companies exporting to the EU? I think that probably they would not, for two reasons.

Subsidiaries

The United States government provides a non-comprehensive list of American testing laboratories that can assist US businesses to comply with EU product safety legislation. Marked with an asterisk are those that are ‘affiliated with EU notified bodies’ and are ‘formally authorized to certify products’. Some of these, such as TUV Rheinland Inc, and Nemko USA, are subsidiaries of European companies. But Underwriters Laboratories, the large American certification, inspection and testing company, is also listed.

A search on the NANDO (New Approach Notified and Designated Organisations) Information System shows listed as Notified Bodies at least three UL subsidiaries, UL International (UK) Ltd, UL VS Ltd., and the Danish UL International Demko A/S. NANDO gives details of the Directives, and the tasks pertaining to them, for which each Notified Body is notified. For example, UL Demko is notified by the Danish Working Environment Authority under the ATEX (Equipment for Potentially Explosive Atmospheres) Directive (2014/34/EU):

Demko

to perform the following tasks under the Directive:

tasks

In a press release, Underwriters Laboratories Inc. announced: ‘UL International (UK) Ltd. Appointed as Notified Body to the Construction Products Directive’. The release goes on to say that:

As a CPD Notified Body, UL UK can test products to applicable European standards (ENs) and European Technical Approvals (ETAGs), utilizing UL’s network of state-of-the-art test facilities and issue a CE Certificate of conformity.

The implication is that UL UK was able to use UL’s facilities worldwide, thus in effect enabling UL to serve as a Notified Body anywhere in the world.

BSI Group, the British Standards Institution, is listed as a Notified Body under 16 different Directives. Its German subsidiary, BSI Group Deutschland GmbH, is listed under 3 Directives for medical devices. BSI also has subsidiaries in the Netherlands, France, Poland and Italy 27:

bsi

Similarly, the London-headquartered Intertek Group plc has fully owned subsidiaries in France, Germany, the Netherlands, Belgium, Italy, Portugal, Romania, Bulgaria, Poland, the Czech Republic, Lithuania, Sweden, Norway, Finland, and Luxembourg. 28 Intertek France (1 Directive), Intertek Italia (1 Directive), and the Swedish Intertek Semko AB (3 Directives) are listed on NANDO as Notified Bodies.

Judging by the example of Underwriters Laboratories, it would seem reasonable to suppose that BSI and Intertek, and perhaps other British companies, would find means to continue functioning as Notified Bodies through their European subsidiaries in the event of Brexit.

Subcontracting

Under the New Legislative Framework (Article R20, Annex I, 768/2008/EC), Notified Bodies may subcontract tasks connected with conformity assessment:

subcontracting

If British testing laboratories were to lose their status as Notified Bodies in the event of Brexit, it would be open to them to find Notified Bodies established in the European Union for whom they could continue to carry out their work on a subcontracting basis. Their technical competence to do so would already have been established when they received their notified status, and their relationships with their clients would be a valuable asset to trade for such an affiliation with a Notified Body.

Conclusion

For many products, there is no need under the New Approach Directives for third party assessment by a Notified Body. This is true of most electrical and electronic products, and of most machinery, for example. In the event of Brexit, so far as compliance with EU product safety legislation is concerned, perhaps the only change of any significance would be the need for an ‘importer’ established in the European Union.

For those products, usually those associated with a higher risk, such as lifts, for example, or explosives for civil use, for which third part conformity assessment by a Notified Body is required, the disruption for British manufacturers is likely to be minimal, and would be modest at worst. Indeed, if the manufacturer was already using a company like TÜV Rheinland UK, or SGS United Kingdom Ltd, which has Notified Body status through the Swiss MRA and 26 laboratories in the UK, then there would be no disruption at all. If it was using a large British company like Intertek or BSI, it seems probable that arrangements could be made through subsidiaries in the EU; if a smaller company, then subcontracting arrangements would seem to be a potential way forward. At worst, the manufacturer could move its business to a company established in the EU, with laboratories in the UK.

For British laboratories, the loss of Notified status would no doubt be a loss, but of modest scale I think. In the first place, testing for CE Marking is only a part of their work; and secondly, as has been said, there would seem to be potential ways for the work to continue, whether through subsidiaries or through subcontracting.

It would appear, therefore, that the New Approach EU product safety regulations would not create a great technical barrier to trade in the event of Brexit. Perhaps surprisingly, in view of the quantity of legislation that issues forth from Brussels, some evidence has been found that if there is a problem, it is rather in the opposite direction, of ineffectiveness in ensuring human safety and protection from nuisance, whether through low levels of compliance, as in the case of electromagnetic compatibility and of sunglasses, or of deficient harmonised standards, as in the case of anti-slip footwear.

Andrew

Notes:

  1. G. Galli and J. Pelkmans (editors), ‘Regulatory Reform and Competitiveness in Europe, I: Horizontal Issues (Cheltenham: Elgar, 2000) p. 16
  2. ‘The “Blue Guide” on the implementation of EU product rules, 2014’, Version 1.1 (European Commission, 15/07/2015) p. 7. Link.
  3. Blue Guide, p. 7
  4. See Blanchard, The Agreement, p. 86
  5. ‘Council Resolution of 7 May 1985 on a new approach to technical harmonization and standards’, Annex II, 136/3
  6. ‘Council Resolution of 7 May 1985 on a new approach to technical harmonization and standards’, Annex II, 136/4
  7. ‘Council Resolution of 7 May 1985 on a new approach to technical harmonization and standards’, Annex II, B.III.1, 136/4
  8. Tim Williams, ‘EMC for Product Designers’, 4th ed. (Elsevier, 2007) p. 23. See also ‘Council Resolution of 7 May 1985 on a new approach to technical harmonization and standards’, Annex II, B.IV.1, 136/5
  9. ‘Council Resolution of 7 May 1985 on a new approach to technical harmonization and standards’, Annex II, 136/9
  10. ‘Council Resolution of 7 May 1985 on a new approach to technical harmonization and standards’, Annex II, 136/9
  11. Council Decision of 19 February 1973 on the harmonization of the laws of Member States relating to electrical equipment designed for use within certain voltage limits (73/23/EEC), Article 6(1)
  12. After Simple Pressure Vessels, Toy Safety, Construction Products, Electromagnetic Compatibility, and Safety of Machinery. See T. Blanchet et al, ‘The Agreement on the European Economic Area’ (Oxford: Clarendon, 1994) p. 83
  13. Council Directive of 21 December 1989 on the approximation of the laws of the Member States relating to personal protective equipment ( 89 / 686 / EEC )
  14. G. Hunwin et al, ‘A study of the effect of modifying the European Standard mechanical slip resistance test for footwear’ (Health and Safety Executive, RR801 Research Report, 2010) p. v. Link.
  15. A. Darby, ‘Optimisation of the mechanical slip resistance test for footwear used in EN ISO 13287:2007’ (HSE, RR951, 2012) p. iii. Link.
  16. Darby, Optimisation, p. iii
  17. ‘Slips & trips and falls from height in Great Britain, 2014’ (Health and Safety Executive, V1, 10/2014) p. 2. Link.
  18. Hunwin, A Study, p.7
  19. M. Liddle, ‘Assessment of slips safety information/ literature provided by flooring and footwear suppliers’ (HSE, RR747, 2009) p. 1. Link.
  20. S. J. Dain et al, ‘Sunglasses, the European directive and the European standard’, Ophthalmic and Physiological Optics 2010 30: 253-256. Link.
  21. Dain, Sunglasses, p. 254, col. 1
  22. Dain, Sunglasses, 256, col. 1
  23. See for example, Williams, EMC, pp. 1-6.
  24. N. Wainwright, ‘Can the New EMC Directive, 2014/30/EU, Stem the Tide of Non-Compliant Products?’ (Proceedings of the 2015 IEEE International Symposium on Electromagnetic Compatibility (EMC)) p. 1459
  25. Blue Guide, p. 21
  26. A manufacturer may appoint an ‘authorised representative, who may also fulfil the obligations of the importer. Some accounts portray a choice between using an authorised representative or an importer. But I think it is clearer to say that an importer is always required and that an authorised representative, who may or may not be the same person as the importer, is an additional option.
  27. The British Standards Institution, (Annual report and financial statements 2015) p. 102
  28. Intertek Group plc, (Annual Report 2015) pp. 129-131

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