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Product Safety, Metrology and Mutual Recognition Agreement (Amendment) (EU Exit) Regulations 2019

Volume 799: debated on Monday 7 October 2019

Motion to Approve

Moved by

That the Regulations laid before the House on 9 September be approved.

Relevant document: 69th Report from the Joint Committee on Statutory Instruments (special attention drawn to the instrument)

My Lords, the extension to Article 50 requires changes to legislation made earlier this year to ensure continued confidence in our consumer safety system. This statutory instrument will amend three earlier regulations: first, a number of product schedules in the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019, made in March 2019; secondly, the Pressure Equipment (Safety) Regulations 2016; and, thirdly, the Conformity Assessment (Mutual Recognition Agreements) Regulations 2019. I will now take noble Lords through the detail of the changes made to each of these regulations—I can see the excitement building.

The change in exit day has created ambiguity for the personal protective equipment industry, necessitating revision to the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019. The opportunity has also been taken to refine the instrument based on stakeholder feedback and ongoing developments in the sector, notably clarifying the continued use of data from pre-March 2013 as it affects cosmetics and ensuring that the UK will be able to update the lists of prohibited or restricted substances in all circumstances going forward.

I am concerned that, following publication of the main product safety instrument, stakeholders drew to our attention a number of these issues. I wish to apologise that these errors were identified by stakeholders after our own internal scrutiny processes had been cleared. Once alerted to these issues, we held meetings with the representative bodies from across the product areas to discuss the drafting errors identified and review the relevant product schedule for any other potential points that might require clarification. Eight meetings were held and a number of phone calls and emails were exchanged with relevant stakeholders. We have sought to do all we can in this regard to catch any issues that might not have been caught in the first instance.

Consequently, minor amendments regarding outdoor noise, recreational craft, toys, electromagnetic compatibility, electrical equipment, radio equipment, simple pressure vessels, machinery, measuring instruments and accreditation will be made. We will also correct the error whereby pressure equipment manufacturers would have been deprived of the option of having their manufacturing processes of base materials certified by a competent body.

Details of the technical changes are included in paragraph 7 of the published Explanatory Memorandum. These could ordinarily have been addressed through guidance. However, the extension to exit day meant that we were required to make an instrument to address specific exit-related issues, and we decided that it would be good practice at the same time to bring these minor changes into legislation to give full clarity for business.

We have also taken the opportunity to update the Pressure Equipment (Safety) Regulations 2016 to ensure full implementation of the importer labelling requirements to make it clear that an importer must put their information on both pressure equipment and assemblies. Post exit, UK importers in some circumstances will be able to put their details on a document accompanying the equipment or the assembly.

The instrument also implements into domestic law obligations that the UK currently has as an EU member state with regard to certain goods imported from Switzerland. This was originally implemented through a global provision in the Conformity Assessment (Mutual Recognition Agreements) Regulations 2019. Following further departmental legal analysis, we considered it more appropriate to make it explicitly clear in the law itself. This instrument will allow UK importers of relevant products from Switzerland to put their details on accompanying documentation rather than on the product for a period of 18 months after exit and extend recognition of Swiss authorised representatives to act on behalf of manufacturers to comply with regulations on noise emissions from outdoor equipment in line with the existing EU/Swiss mutual recognition agreement.

A full impact assessment has not been prepared for this instrument because no provisions trigger changes to in-scope operational costs. The impact is limited to familiarisation costs for business, which were previously assessed in a full impact assessment on the earlier instrument as de minimis. A copy of that full impact assessment is publicly available on

On consultation, the department has benefited from significant stakeholder feedback following the passage of the original regulations, all of which has been taken into account in the revised instruments. However, clearly, this was the wrong way round. As I said when taking forward regulations last week, my department will reflect carefully on ensuring adequate consultation before bringing forward such complicated legislation. This commitment from the Dispatch Box follows on from issues raised by the Joint Committee on Statutory Instruments, whose comments we welcome and will take fully on board.

The amendments made by this instrument will ensure that instruments are correct and that our high standards are maintained after our exit from the European Union. I beg to move.

My Lords, moving between topics as varied as Hong Kong to product safety is one of the joys of being a Front-Bencher in the House of Lords.

The House is again debating an instrument to rectify problems with previous no-deal regulations, this time on the crucial issues of product safety and metrology. Before I delve into the specifics of the instrument on mutual recognition, I ask the Minister to explain why the House is still debating regulations which will apply only in the event of no deal when the recent European Union (Withdrawal) (No. 2) Act will prevent such a scenario. This feels both disrespectful of Parliament and a little bizarre.

Much of the instrument is intended to ensure that previous regulations will be operable for the latest exit date. As he was asked last week, can the Minister confirm that Parliament will be asked again to revisit these issues if the exit date is again changed?

According to the department’s Explanatory Memorandum, the regulation strives to ensure that products placed on the UK market continue to meet,

“substantially the same essential requirements”.

Why is it only “substantially” the same requirements, not exactly the same ones? If there is no difference, will the Minister clarify this? If there is a difference between substantially copying over requirements and completely doing so, which ones are not required to be copied over?

These regulations cover a wide range of products, from civil explosives to children’s toys. It is imperative that Parliament can fully scrutinise all legislation. I fear that the Government have crammed in amendments to so many items of secondary legislation, some of which have little relation to each other, that it may be difficult for the House to examine each necessary reference. How many separate pieces of legislation are within this instrument? I ask because I had a shot at trying to decipher some of the language. I understand the complex nature of this and how difficult it is, but we are debating important statutory instruments week after week. In Part 3, Regulation 11 states:

“In Schedule 12— … (e) in paragraph 30 … (i) in paragraph (b)(iii) before ‘third’ insert ‘second paragraph and the’”.

That is not simple or straightforward.

I understand that the Minister has come to the House to explain that a number of difficulties and issues have arisen with this since my noble friend dealt with it the first time round. It is important that these are rectified, but its complex nature makes it neither easy nor simple. Did the department give any consideration to splitting the regulations into separate affirmative instruments, which may have made it a bit simpler?

Finally, the Government have claimed that no consultation was necessary on the drafting of this instrument. In his opening remarks, the Minister talked about “stakeholder feedback”, but paragraph 10 of the Explanatory Memorandum, headed “Consultation Outcome”—which the Minister touched on—states that there was no consultation. If there was a need for stakeholder feedback and if that fed into changes to the SI, why was there no wider consultation with the industry?

We have no intention of opposing this instrument, but I would welcome any attempt by the Minister to clarify the Government’s intentions on some of my previous questions. As the House again finds itself debating legislation that will enable a no-deal exit, which Parliament will not sanction, will the Minister offer an estimate of how many further redundant instruments it will be asked to consider?

My Lords, once again I associate myself with the comments of the noble Lord, Lord McNicol, about the necessity for this debate, but now that it is here it is important to get it right so I am happy to have it.

I refer noble Lords to my entry in the register of interests. I am not actually sure whether I have any interests which coincide with this instrument, but it seems impossible for there not to be, given that it covers ear-plugs to aftershave and toy trains to industrial pumps via explosives. The breadth of this SI is its weakness, because it is trying to bring together a compendium of things that need to be cleared up. I have complete respect for the team that has worked hard on trying to do this, because it really has a very broad remit. It seems unlikely to me that there is not another issue or two in here, so I welcome the Minister’s undertaking to continue to be vigilant on it. Perhaps he could undertake, in the event that further issues are uncovered, that further versions of this will be brought forward.

The point made by the noble Lord, Lord McNicol, about stakeholder involvement is absolutely right. The threshold of monetary value used is not always the right threshold when we are dealing with statutory instruments of this complexity; the problems and issues it creates for business are hard to monetise, and in this case the Government would have been best advised to err on the side of involving as many people as possible. I suspect that there is still a need to do that.

I shall make a couple of general comments and then focus on one particular issue—I am very pleased that the noble Lord, Lord Gardiner, is in his place, because it crosses over into the next instrument, and he will guess what it is about. My first point concerns the Explanatory Memorandum, which talks at paragraph 2.3 about manufacturers having to have either self-certification or third-party conformity assessment. It is not clear whether that is a change from the current situation—in other words, what was acceptable for self-assessment, will that remain, or will people either have to have increased or indeed, decreased third-party conformity assessment as a result of this change?

My second point mirrors exactly what the noble Lord, Lord McNicol, said about paragraph 2.6 of the Explanatory Memorandum and,

“substantially the same essential requirements”.

That means that not all of them are, yet there is no list of what is materially different. I think noble Lords should be aware, in detail, of what is actually the difference between this andwhat it seeks to replace.

I come to the issue I want to talk in some detail about. Regulation 8 talks about CMR chemicals; those which are,

“carcinogenic, mutagenic or toxic to reproduction”.

Much of the change the regulation makes is around labelling, but the reference to Schedule 34 talks about “historic animal testing data” and starts to stray into issues that the noble Lord, Lord Gardiner, will know we have discussed around REACH and the rollover use of historic data. It seems strange to me that we are trying to cover similar issues in two separate statutory instruments. What consultation has gone on between BEIS and DEFRA in the drawing up of this, and why should it all not be covered in one instrument?

That also causes me to raise, yet again, that in essence the SI brought by Defra, the REACH etc. (Amendment etc.) (EU Exit) (No. 2) Regulations 2019, which has yet to be tabled, has very severe financial consequences for the chemicals and cosmetics industries in this country. In the case of the chemicals industry, the relationship is managed, I think, by BEIS, rather than by Defra, so it seems to me that there is a lot of crossover here which is not necessarily finding its way through in the statutory instrument.

So there is work to do. First, it must be explained how this has come about as a separate part of a different SI, whereas it is not part of the one that dealt with that the substantive issues of chemical regulation. What awareness does BEIS have of the scale of costs that will be imposed on the chemicals industry by the implementation of the chemical regulation statutory instrument brought by Defra? We need an overall look at the process of delivering a sensible statutory instrument that is able properly to use existing data. There are extreme issues around the portability of potential data that seem to have been overlooked and will cause problems for the industry, and indeed for consumers who use the chemicals that are made by the chemicals, cosmetics and consumer chemicals industries.

Therefore, I ask the Minister—who I see is talking to his colleague—to undertake to do something that actually brings these together and gives us some clarity.

My Lords, I draw attention to my interest as chair of National Trading Standards, which, as far as I know, is not involved in any of these regulations—but for all I know it might be.

I would like some clarity on two specific points. First, the Minister said that no specific impact assessment was drawn up for this statutory instrument, but that it was covered by the previous impact assessment and that the main impact would be in explaining these changes, which we all look forward to, to the businesses affected by them. Did that assessment also look at the role of explaining these changes to those who are responsible for enforcing the regulations and for ensuring proper compliance? It seems to me that this is quite an important area, particularly when we are talking about product safety.

Secondly—I hope this is not frivolous—as I understand it, according to the report of the Joint Committee on Statutory Instruments, there is an error in the instrument. The reference to Regulation 15 should have been to regulation 18. The department accepts that this is an error but says that it probably does not matter—I am paraphrasing. I think it is implying that there will be a 24-hour gap during which the mutual recognition agreements will not be in force. If that is the case, will the Minister tell us how frequently the mutual recognition agreements referred to in this SI are in fact employed in this country, and whether an issue really is unlikely to occur during the 24-hour gap?

My Lords, this suite of regulations is quite technical, as the noble Lord, Lord McNicol, said. The original suite was a bundle, and anyone who has managed to carry it around will recognise that it could be measured in depth of inches. The important thing to stress is that I have recognised what a challenge it is to face such a large document. I would not wish to see us go forward on that basis again, for the very reasons flagged here today. I am very happy to say that, as far as I can influence the situation, I will do that very thing.

It is also important to stress—this comes back to the notion of why we are where we are—that the date changes which were necessitated by the change in the exit date were necessarily made in the document we are debating. It has now been—I am going to use the term—Brexit-proofed, in so far as we will not have to revisit these dates because of the manner in which they have been drafted. I reiterate, however, that it is the Government’s policy to leave the European Union on 31 October and noble Lords would expect me to say that, so I am saying it again.

I will go through some of the points raised in the order they were made. The noble Lord, Lord McNicol, again raised the issue of “substantially” versus “exactly”. My team tells me that broadly they are the same. Noble Lords might notice that I used the word “broadly” in that particular context, but they are the same, so they should not be interpreted as being in any way different. As to the question of the stakeholder feedback—

“Broadly” and “substantially” are broadly the same phrase, but why is that phrase being used? Is it because the department is not aware that there are any differences but thinks that there might be unintended differences, or is it aware that there are actual differences between the two situations?

My team has helpfully provided a note on that, just in case someone was querying whether they were indeed the same. On “substantially the same” and an essential requirement, certain essential requirements require the involvement of notified bodies. Post exit, these same essential requirements will require the involvement of UK-based approved bodies, in line with the UK-only system developed under the no-deal legislation. We are therefore at that stage of approved versus notified. There will be differences, in essence, but the substance of those differences is textual rather than meaningful in that context—I hope that is helpful and makes sense.

We are getting there, but I am not sure that I know the difference between an approved and a notified body. Perhaps the Minister could write to me and the noble Lord, Lord McNicol, and place a copy in the Library, explaining what difference the word “substantially” makes regarding which organisations are involved in future versus those involved now.

I would be happy to do so, because we are stepping into the etymological element of the debate. As I understand it—I will happily put this in writing—the notion of a notified body and an approved body differs in so far as which is recognised by which entity. The UK itself has a recognised approved body whereas the notified body stems from the earlier legislation. However, rather than going too far down the rabbit hole of exactly how that works, if the noble Lord, Lord Fox, will allow, I will write to him on that point.

On the question of stakeholder involvement, in truth, this is why I apologised. We did this the wrong way round—there should have been greater engagement in advance of such a complex and dense series of materials, to ensure that we had captured all the elements the first time. We did not do that, and we were blessed by the fact that a number of directly affected organisations raised with us the substantive points which have led to the minor changes we have before us today. In truth, although I say they are minor, they are none the less changes we would wish to make to the body of the law—to the instrument itself. However, I acknowledge that this is the wrong way round, and I have said that on the record.

I am grateful to the organisations which have come forward. I am also aware that, once that began to happen, my departmental team therefore recognised that it had to do a thorough combing exercise of the substantive element of the original instrument. I asked the question which I think a number of noble Lords will have asked: “Is there a risk of institutional blindness? If you missed it the first time, will you miss it the second time?” That is why, again, I was assured that the manner in which the second, third and fourth iterations were conducted involved different groups to ensure that we were able to bring before you what we believe to be the comprehensive elements of the corrections which need to be made. I can go through them with your Lordships if you like, but I have a feeling that you probably do not want that. If noble Lords allow, I will therefore put that record into the Library for your consultation. However, noble Lords will be aware that it covers the full range, as the original instrument did, and as we are learning today, it is quite a broad range.

The final point raised by the noble Lord, Lord McNicol, was whether there are any other redundant statutory instruments. The answer to that is, not to my knowledge. There you are.

Noble Lords will discover that I am full of these lines.

The noble Lord, Lord Fox, raised a couple of points. There should be no change to self-assessment whatever. On the question of the carcinogenic, mutagenic and reprotoxic elements—CMR—the rollover of the historic data rests within this particular body because it affects the elements within the EU-defined law which we have brought across. However, the noble Lord is right to note that clearly, the ingredients which are part of these elements rest within the wider EU REACH directive, and therefore will fall under the jurisdiction and leadership of Defra. Happily, I can confirm to the noble Lord, Lord Fox, that my noble friend Lord Gardiner will indeed facilitate such a meeting with him regarding the costs of the wider registration or reregistration of chemicals by a British entity. In due course, therefore, such a meeting will take place, and thereafter I hope that we will place on the record useful information for the entire House.

The noble Lord, Lord, Pickles—

I apologise. My goodness, I would not wish the noble Lord to be seen as dallying with the other side. The noble Lord, Lord Harris, raised two specific questions, including on the impact assessment in its broadest sense. The detailed impact assessment was specific to the original material. He asked about the familiarisation costs and whether they encompass the costs resting on bodies responsible for enforcement and compliance. The answer is yes, they need to do so, for obvious reasons, because they will have to take forward the management or oversight of this broad area.

As to the question of the 24-hour gap—this feels a bit like the Richard Nixon tapes: a gap during which something has gone on—my team tells me that the answer is no. Immediately before exit date means exactly that. The gap will be a few seconds, and my team assures me that in those few seconds, very little should interfere with the continuity which this suite of instruments represents.

I hope that that answers the questions raised. I also appreciate that this is a technical instrument. This is not the way I wish to do things in future, and I will ensure that there is adequate consultation not just with your Lordships but with wider interested parties. I will learn that lesson and will ensure that my department learns it. On that basis, I commend the Motion.

Motion agreed.