Report for BSIF members of the Workshop on the transition from Directive 89/686 to Regulation 2016/425 16.11.2016, Brussels
Prepared by Henk Vanhoutte, Secretary General, European Safety Federation
Workshop chaired by Birgit Weidel, deputy head of unit + Niccolò Costantini, policy officer
+/- 100 participants from authorities, notified bodies and suppliers
After a short introduction (with the most important changes), the text of the Regulation was followed for the interactive question-answer session.
General remark :
- the Blue Guide (newest version also available in different languages and published in the Official Journal of the EU on 26.07.2016) gives good explanations on the definitions and other elements of the NLF and thus the PPE Regulation. See : http://ec.europa.eu/DocsRoom/documents/18027/
- EC type examination certificate means certificate issued based on Directive 89/686. EU type examination certificate means certificate issues based on Regulation 2016/425
editorial remark :
- where COM is used in the text, this means the EU Commisison. Every time A is mentioned below, the answer comes from COM unless otherwise specified. I have tried to write this report as close as possible to the actual discussion that took place. Text in bold italic is either a question for members or a comment from myself.
- Where possible I added for the Questions from which type of participant the question came (manufacturer – authority – NB)
Article 3 : definitions
most definitions are copied from NLF (new legislative framework).
Q (manufacturer) : why is the ‘very first time of placing on the market’ not included (in other words principle of ‘type of PPE’) ? now only placing on the market for each individual product.
A : is taken over from NLF from the idea that each individual product has to comply with the legislation. For a manufacturer there is indeed a difference between the very first time and each following time.
Q (manufacturer) : in e.g. ATEX there is a different approach where the transition is very simple.
A : the revision of the PPE legislation is not different than ATEX. However, in ATEX there is no change in scope or requirements, while in PPE there are substantial changes. The same approach is being followed, also in ATEX there is the issue of new production.
Q : definition 1, part c : what is meant by ‘fastening works’ ?
A : anything that needs fastening (e.g. with bolts) and thus can not be taken care off by the individual user is not PPE.
Q : could this be interpreted as ‘when a tool is needed’ it is not PPE ?
A : could be an interpretation, but needs further discussion in the PPE Working Group with the member states. This wording was an attempt to clarify the old discussion of e.g. fall protection. COM understands that there is still a grey zone that needs clarification
For members : new examples of this are always welcome
Q (authority) : on own use PPE : if a manufacturer makes a product for own use, recital 23 mentions the safety requirements, but does this mean that the manufacturer also has to comply with the administrative requirements ?
A : recital 23 stipulates that the product has to comply with the Regulation as if it would be placed on the market.
Chapter II : obligations of economic operators
Q (manufacturer) : concerning article 8.4 – recertification every 5 years : so every 5 years all aspects are considered (e.g. state of the art at that moment). In practice, the revision of (harmonised) standards is not synchronised. In some cases of protective clothing, up to 9 different standards are used, which means there is always one of those recently revised. This article can be understood that with each revision of a standard the PPE has to be recertified with the latest version. Is this correct ?
A : a simple yes or no is not possible. The answer depends on the changes in the standard. There has to be a discussion between manufacturer and NB about the changes in the standard. And this needs to be documented. This can mean that no longer a harmonised standard is used but another technical means (e.g. previous version of standard) to demonstrate compliance with the EHSR (Essential Health and Safety Requirements).
Q : This already creates today discussions with the Member States, even with statements from manufacturers and NBs. A harmonised approach is necessary
A : Blue Guide 3.1 point 7 gives an answer. Each manufacturer has to follow the state of the art, independent of the validity of the Type Examination certificate.
Q (manufacturer) : why need for 5 years validity of certificates ? this will cost the manufacturers (SMEs) a lot of money. NBs use different approaches and apply very different costs for renewal of certificates.
A : there was clearly a problem with certificates that are very old (based on standards that have been revised several times in the mean time). The 5 years validity is a solution to this issue.
Q (NB) : for cat III products, can the NB oblige a manufacturer to have the type examination certificate updated if a harmonised standard has been revised ?
A : again, the basis for the decision is : what has been changed in the standard ? some sort of documentation that the new version of the standard has been considered is necessary. Then it is up to the NB (e.g. annex V 7.1)
Q (NB) : what will market surveillance authorities do in such cases ? in many cases they only look at latest version of standard or not. This needs to be harmonised.
A : COM asks member states to respond :
- DK agrees that authorities are not harmonised. They need to look at the time the product was placed on the market. But they realise that in other countries the authorities think differently
- UK authorities look at the compliance with the EHSR, not compliance with a specific version of a standard. They never take action based on the version of the standard alone.
- COM agrees that the EHSR are the only basis, standards alone are not enough to judge.
- Comment from manufacturer : in practice everybody (users, employers, authorities, …) talk in terms of standards, not in terms of EHSR of the legislation.
- COM agrees that the legal requirements can be different from the market drive. Also standardisation bodies have a role to play in this discussion.
Q (authority) : concerning article 8.6 requirement on single contact point : is this one contact in the EU, or one per country, or … ?
A : one contact point in the EU. In case of a branch in the EU of a manufacturer outside the EU, the EU address is sufficient if the EU branch takes full responsibility as manufacturer (otherwise, address of manufacturer outside the EU + name and address of the importer (which would be e.g. the EU branch).
Q (manufacturer) : how to understand EU in this context ? only the EU members ? or broader (see single market which is broader than the EU) ?
A : EU certainly includes EEA (e.g. Norway). Turkey and Switserland are different cases. They will clarify this by publishing a list of countries covered by EU in the legislation.
Q : concerning article 8.5 : is barcode acceptable to indicate identification ?
A : if the traceability can be guaranteed with a barcode, yes then a barcode can be enough. There is flexibility in the way the traceability is guaranteed by the manufacturer. In case a product needs to be recalled then depending on the level of detail of the identification, the recall action can be limited to a e.g. a specific batch or has to be done for all products with that reference.
Q : is there a contradiction with annex II 2.4 (obligation to indicate date linked to ageing).
A : this point of annex II is not applicable for all PPE, so no contradiction
Q : concerning article 8.6 : what are the options for the indication of the postal address ? a website e.g. ?
A : no options, the address must allow the delivery of a letter. Websites are not a reliable source (can be everywhere, can be changed easily, can disappear, …), hence still the obligation to indicate a postal address. This is a general discussion on horizontal level, not only for PPE.
Q : concerning article 8.8 : obligation to supply the DoC (declaration of conformity) with each product either in full or with link to website. How detailed must the link be ?
A : the internet address can either be a specific page where the DoC for that product in a given language is available. Or a more generic page with a search function so that everybody can get to the DoC in a few steps.
Q (manufacturer) : is a QR code enough to give the link to this website ?
A : the Regulation is not intended to kill innovation, but at this moment the answer has to be no as not everybody has access to smartphone to read QR codes. However, this can change in the future.
Q (authority): what if a manufacturer has the DoC on a website but goes out of business ?
A : the importer also has to have a copy of the DoC available.
Chapter III : conformity of the PPE
Q : concerning article 15 : from which date must the Regulation be mentioned on the DoC ?
A : before 21/4/2018 only the Directive is valid. In the transition year, PPE can be placed on the market in compliance with Directive or Regulation, so DoC can refer to either. Products already on the market before 04/2019 can continue to be made available (unless of course safety issues occur). Content of DoC is given in annex IX.
This means in practice that all products that are placed on the market by the manufacturer or importer can remain in the supply chain indefinitely. For all concerned economic operators it will be important to have a clear paper trail to demonstrate when products were placed on the market.
As this issue is very much related to article 47 (transition period) it is asked if it is possible to treat this article first. Member states also ask specifically for a written COM document with these interpretations.
COM replies that Q&A will be produced based on received questions and discussions of this workshop. These will be published on the PPE website of the Commission (http://ec.europa.eu/growth/sectors/mechanical-engineering/personal-protective-equipment/ ). The aim is to have the first Q&A available before the end of this year.
Article 47 : transitional provisions
Paragraph 1 : in this 1 year period, manufacturers can place products on the market that are in compliance with the Directive or with the Regulation.
The idea is that for most products the changes are limited to documents and marking, so COM is of the opinion that this must be possible to achieve during this 1 year period.
Q : what about certification ?
A : paragraph 2 was introduced because of the 5 year validity of EU Type Examination certificates, which was not existing in the Directive. So for EC Type Examination certificates that have no expiry date, this paragraph introduces an expiry date.
21/04/2019 is the cut off date for manufacturers to place PPE on the market that are in compliance with the Directive (so DoC on Directive, etc).
From 21/04/2019 only a EU Type Examination certificate based on the Regulation can be used to place PPE on the market.
So indeed all products have to be recertified before 21/04/2019.
Q (manufacturer) : what about the capacity fo the NBs ? there will be a serious problem.
A : what does recertification mean ? for COM, it does not mean that the complete procedure has to be done. NBs should certainly not do the complete assessment. In most cases the recertification is only updating of references (Regulation instead of Directive) in documents, technical documentation, labelling and DoC. This means a limited exercise for all involved, just paperwork, certainly not a reason for re-testing of the PPE.
Q (manufacturer) : in cases where the standards have been changed recently (or at least since the issue of the last EC type examination certificate) this will mean a complete assessment. In practice this means a lot more than just administrative work.
Statement by the chair of the HCNB (Horizontal Committee of Notified Bodies, so European coordination of Notified Bodies) : estimates that at least 20% will not be ‘easy’ as stated by COM. And even just the administrative re-certification means a lot of work. This will be a huge task and capacity will certainly be a problem. The re-notification of the NBs is a big issue – this has to be done ASAP by the member states.
Statement by the chair of the French national coordination of NBs : adds that this will mean every 5 years a huge volume of renewal of certificates will return. And looking at the Regulation this re-certification can not be just administrative. What is the legal basis for each product and not type ?
A : if no change in the product, no need to re-test as the results from the past can still be used.
Q (NB) : what if the deadline for acceptance of test reports is passed ? cat III should not be an issue as those products are tested regularly, but for cat II this can be an issue. VG 5 has a recommendation with a deadline of no less than 5 years. VG 10 of 2 years. So it seems that stating that no testing is necessary is pure theory.
A : the question is if the product is still state of the art, has not been changed, … If EC type examination certificates are older, it might be necessary to look into it more carefully. In any case, the manufacturer remains responsible for the continued compliance with the legislation. As for the age of test reports that can be accepted : a general response is not possible, this needs to be looked at case by case, or at least in the coordination of NBs.
Statement (manufacturer) : will NBs use the latest standards to make the assessment ? it seems the answer is yes, which means that the update of the certificate is not administrative.
Statement (Spanish NB) : accreditation to Regulation is already finished, not such a big issue if already accredited for the Directive. As for the re-certification : the manufacturer has already the obligation to notify the NB of any changes in the product. If the NB believes the statement of the manufacturer concerning his products, then the re-certification is pure administrative and not a problem.
Q (authority) : what are the consequences of article 47.2 for market surveillance authorities ?
Q (manufacturer) : re-certification assuming no changes means pure administrative, annex V 7.5 mentions limited costs related to administrative burden. In practice this seems to be very variable between NBs, and in any case even if pure administrative a huge investment for SMEs.
Q (authority) : what does article 47.2 mean ? a product placed on the market before 21/4/2019 is clear, but what does the date of 21/4/2023 mean ? article 47.2 has no influence for products placed on the market before 21/4/2019 as they can stay in the supply chain anyway (unless safety issue of course). So what is the meaning ?
A : market surveillance should also act proportionate with the infringement. If the only issue is EC type examination certificate instead of EU type examination certificate, this is a pure formality, not a safety issue, so the measure should be proportionate. We have to consider carefully what it means ‘requirements not changed’. It is clear that there are different opinions about the scale of the consequences.
Q (NB) : question about legal basis for individual product instead of type has not been responded completely ?
A : all legislation refers to product, not to type of product. Each product has to be safe. This works of course also both ways. The legislation allows certification for the type to facilitate the system as certification for each product would not be possible.
Q (manufacturer) : manufacturers do not change their products or production all the time. If the time that test reports are accepted is too short, innovation will be killed given the time frame necessary from development to market.
For products where the certificate is 15 years old or with a 1 year old certificate with a standard that has changed means the same work and burden for the manufacturer.
COM agrees with this last statement.
COM summarises : all manufacturers have to change from Directive to Regulation :
- Type examination certificate : after 21/4/2019 has to be EU type examination – so Regulation
- DoC : all products have to have one – see annex IX
- Labelling : address + name and address of importer in case manufacturer not in EU + identification of product
- Technical documentation : needs to be updated with correct references (see annex III)
Q : can products be manufactured in compliance with the Directive between 21/4/2018 and 21/4/2019 ?
A : the Regulation does not mention anything about production, only on placing on the market – so up to manufacturer to decide when he produces
Remark : this is a different statement from COM than expressed earlier this month at the ADCO meeting
Q (manufacturer) : is there any means to extend the transition period ?
A : no, what is in the Regulation can not be changed. The preparations by all concerned can already start – there is in total 3 years.
Q (NB) : for NBs with a lot of certificates, the capacity will certainly be an issue and will be every 5 years. And for instance for gloves, both EN 388 and EN 374-1 are changing now or in the near future – this means certainly a lot of testing involved as well.
A : preparatory work can already start today. Those NBs that are already accredited for the Directive should not have too many problems to get accreditation for Reguatlion.
Q : so the same product placed on the market on 20/4/2019 and on 22/4/2019 has to have different certificate and documents.
A : 21/4/2019 is the ultimate cut off date – this is for all legislation that at some point there is a cut off date.
Q (authority) : art 47.2 also mentions ‘approval decision’ – what does this mean ?
A : this is related to the article 11A/11B procedures from the Directive (so for category III products)
Q (authority) : are art 47.1 and 47.2 related ?
Q (authority) : so EC type examination certificate issued before 21/4/2018 is only valid in practice till 21/4/2019. Is this correct ?
Q (NB) : for cat III products. During the transition period, some products have EC type examination certificate, others EU certificate. Which procedure for quality system ? article 11B (Directive) or annex VII (Regulation) ?
COM : it seems that it would be best to use annex VII, but must be confirmed (they will further examine)
Q (authority) : based on art. 46 it is not possible to issue EC type examination certificate or assessment.
A : yes it is possible to issue EC type examination certificates (and approval decisions) till the end of the transition period. This based on article 47.
Remark : this response came as a surprise to most of the participants as everybody seemed to agree that EC type examination certificates were not possible anymore from 21/04/2018 onwards.
Several authorities made it clear that they do not agree with this interpretation.
COM states that they hear the concerns expressed and that they will monitor the situation.
Statement from manufacturer :
- This re-certification comes as a surprise. COMs earlier statement that this was not brought up by stakeholders e.g. in the negotiation phase is not correct
(see e.g. ESF proposals for the parliament to include a definition for ‘type of PPE’ and use that in the text)
- Statements from COM that it is ‘simple’ are not fully correct in practice. A quick estimate learns that it will cost this one manufacturer hundreds of thousands of euro. So what about the ‘lead market for protective textiles’ of a couple of years ago ? COM made a clear statement then that they wanted to support the EU industry as leading in the world. Now they put huge burdens on the same industry for no reason.
COM response : the decisions were taken by Parliament and Council and already part of NLF. Not a Commission decision. COM can not change the text of the Regulation. COM is doing their best to manage the transition in an as smooth as possible way.
Chapter V : Notified Bodies
COM remarks that it is important to proceed with the notification as quick as possible so that the NBs can be included in the NANDO list.
Q (authority) : will the NANDO list for the Directive remain on the website till 4/2019 ?
A : yes. There are already 2 lists available on NANDO – 1 for the Directive and 1 for the Regulation.
Q (authority) : it needs to be very clear that the NBs (Directive) remain in NANDO till 2019 and not till 2018.
COM will prepare a clear document on this.
Remark : there are indeed 2 lists on NANDO, so make sure to check the correct list for the Regulation (http://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.main ) The list on top of the page is for Directive 89/686 – the list for the Regulation 2016/425 is on the bottom. Make sure to check the correct list !
COM remark to the authorities : the requirement for NBs to participate in the coordination is an important criterion. Bodies that do not participate do not fulfil this requirement (and should does not be notified).
Chapter VI : market surveillance
COM insists on using ICSMS (The internet-supported information and communication system for the pan-European market surveillance – https://webgate.ec.europa.eu/icsms/?locale=en ) as exclusive tool for communication and notifications to the Commission. ICSMS should be fully operational in all member states before 04/2018.
Q (authority) : what are the language requirements for e.g. safeguard procedures ?
A : this is also linked to ICSMS. The basic information on products and the problems with the product is in English, supporting documents can be in any language. COM will also come back on this at a later stage.
Q (authority) : concerning article 41.1 (g) : what is meant by ‘any other administrative requirement’ ?
A : not all requirements are administrative
Q (same authority) : OK, but which ones are considered to be administrative ?
COM : we will find examples – see also Blue Guide
Annex I : categories
Now only risk based.
Q : why is head protection still cat II
A : indeed still cat II, there has not been an assessment for this change, so not taken on board. Could be subject of a ‘delegated decision’ if found necessary.
Annex II : essential health and safety requirements
Q (authority) : Requirement 1.3.4 is new, what about non protective clothing containing removable protectors ? what is meant by ‘containing’ ?
A : as soon as clothing contains protectors it becomes by definition protective clothing. If there are e.g. pockets foreseen to place the protectors, that could mean ‘containing’. But this needs further consideration for the guidelines.
Q : concerning preliminary statement 4 : risk assessment is mentioned but also in annex III risk assessment is mentioned as part of the technical documentation. But not with the exact same wording. Is this the same meaning ? or different ?
A : the risk assessment has to be documented in the technical documentation. Even if the wording is not exactly the same, the intention is that it is the same meaning.
Other annexes :
COM highlights the simplified procedure for re-certification of annex V 7.6. repeats that this is probably also useful for the transition from Directive to Regulation.
Q (NB) : annex V 4 (a) states that point (j) of annex III (technical documentation) does not need to be taken into account. How must this be understood ?
A : annex V 4 (a) is concerning the assessment of design of the PPE, not the assessment of the production. Annex III (j) is pure on production and thus not relevant here.
Q : maximum validity of EU type examination certificates in annex V : what is in practice the new start date of the certificate ? the end date of the previous one ? or the date the ‘new’ certificate is issued. In the latter case this means in practice always less than 5 years.
A : no answer to this Q
Q (authority) : concerning annex VII 4.3. what is meant by ‘adequate statistical sample’ ?
A : this was subject of intense discussions during the negotiations with Parliament and Council. The intention is that the sample must represent the complete production (different batches, different production lines, …). This as opposed to random sampling which could mean that all samples are taken from the same production batch.