Understanding Electronic Signature Lawfulness for Property Inspection Report in European Union

How to eSign a document: electronic signature lawfulness for Property Inspection Report in European Union

safer chemicals podcast sound science on harmful chemicals [Music] hello and welcome to the first episode of the year of the safer chemicals podcast to kick start the year we're going to be talking about an EU enforcement project that focused on the authorization requirements of the reach regulation now authorization is a process under the reach regulation so this is the eu's chemicals legislation and its aim really is for Dangerous chemicals to be progressively replaced by less Dangerous Ones where alternatives are available under authorization chemicals are added to a so-called authorization list also known as Annex 14 by the European Commission once on this list companies need to apply to continue or start using and placing these chemicals on the market it's worth mentioning that any continued use of these chemicals is only allowed if there are no economically or technically feasible alternatives now the reach on Force 9 or ref9 project that we'll be talking about today looked at both the placing on the market and use of these chemicals very high concern but also the requirement for Downstream users to properly control their risks Downstream users are mostly small and medium-sized companies such as formulators for example who prepare paints glues and detergents or professionals that use chemicals like oils or lubricants in industrial processes for example for electronic components toys or cars back to the project so the ref 9 project found that most companies comply with the fundamental authorization duties but also that for example 26 percent of checked substances were not used by Downstream users ing to the conditions required by the authorization we'll be taking a closer look at the findings on next steps I'm joined by Oregon anwander the chair of the working group for the project who also represents the member state enforcement authorities also with us is muchek baronsky who works in the harmonized enforcement team here at the European chemicals agency thank you both for joining us let's start with you organ can you tell me why did The Forum decide to focus specifically on reach authorization yeah they're of course was this key process under reach which focuses on the most harmful chemicals authorization with this facing out of the most hazardous chemicals and this was for sure the major reason because there was never done a full-scale project in all the member states on this Rich authorization right so we wanted to do this important inspections uh including now oil substances from Annex 14 uh and including really all the placing on the market or the uses uh the overall Focus was with substances where the sunset dates have passed when we started with the project so in January uh 2021 and in this way we were then able to cover 43 substances from these 59 which are in Onyx 14 in the moment yeah and then uh we also observed that for some of the important substances we have quite a limited number of applications and authorizations but at the same time we have uh widely placed on the market the substances we have a broad use of these substances in the member states and we wanted really to see what what does this mean sorry maybe just to interrupt you there you know you mentioned some of these substances so so can you give an example uh for example doctromate so the sodium chromate or the strontium chromate lead chromate or the chromium trioxide these are these uh very broad substances so in terms of placing on the market in terms of use right and are you actually able to say a little bit what kind of uses these have just a couple of examples of how they're used yeah typically they they are used either as pigments for example the let chromate uh intend a very broad use is really on the surface treatment of metals of various Metals this is quite often in the automotive and in the uh Aerospace Industries okay thanks a lot for that there was another reason uh we wanted to focus on aspects which were not covered at the time we did the pilot projects so really for the first time to focus on the substance use and then also on those downstreams users which were using the substance which was subject to an authorization that was granted to A supplier of this Downstream user so the downstream user himself was not holding the authorization this includes them also the need for a good supply chain communication and we also wanted to have a closer check on that well let's then go closer into uh what the inspections looked at can you tell me a bit more about that and how many countries also participate in the project 28 member states uh and it includes also countries from the eea from the European economic area and then these countries started the inspections and the individual inspectors started his inspection work then this was always focusing on substance inspections and the first step of course was to confirm that the substance which was targeted with the inspection was actually really a substance which is listed in onyx14 and for which the Sunset date has passed so uh when you start very generically from information where you only know that the substances might be chromates then you really have to drill into this detail to understand that the actual chromate used is the one listed in the Onyx 14. okay and just just for my own own benefit um how is that check actually done so where do you get that information how do you do the comparison in practice Yeah practically you try to do this this paperwork so you see the substance name uh in the ingredient list of of your chemical right and here typically the safety data sheet helps you and when there is of already a authorization granted then maybe even an authorization number which is obligatory can help you in identifying the context okay clear yeah then once this is established that the substance is really a relevant one the inspection tries to identify better uh relevant authorization was already granted uh for this substance either for the placing on the market or for the use it depends on the inspection context and if there is no authorization granted then the next step is to see maybe the authorization was already applied for and is still processed and authorities and then there might be also a situation where the placing on the market and the use takes place under a specific exemption from the authorization requirement and uh 10 uh there was also an inspection goal to see that whatever needs to be communicated in the supply chain is really communicated by the suppliers in line with the provisions of the authorization decision it was also important to check uh that the chemical that was used was from a so-called valid supply chain a supply chain where really the authorization was there or an application for authorization both there and the downstream users that use the substance are required to notify the European chemical agency about their use so we also checked for submission of this notification ing to article 66 of the rich regulation uh then there was also an important aspect that once we identified that the substance was already authorized and authorization conditions were in place that the downstream uses uh really have acknowledged these conditions and implemented the necessary safety measures this is of course quite the profile of what is inspected and we weren't lucky to see member states really submitted 690 questioners to the working group and eventually we then could identify that out of this number 502 inspections really could including to the analysis and this was then inspections in 404 companies which we could include in our report okay so let's move on then um more specifically to those um that were found to breach really breach the authorization requirements so can you tell me about the substances there and maybe also the companies and the countries where these breaches were found yeah in general we we found uh that out of these 502 substance inspections which I mentioned before 2003 really identified some kind of breach which makes an overall non-compliance rate uh for these inspections of the 40 and actually it's exactly the same figure also when we look into this non-compliance rate in terms of companies so also 40 of the inspected companies were non-compliant okay 40 now that that to me sounds like a large number of non-compliance I think when you see the figure with the 40 percent of non-compliance rate for the inspections but but also 40 percent of the companies which we inspected actually uh this this looks quite the high number and also for an inspector this is uh well above the usual level of non-compliance that we find which is maybe something like 10 percent uh but we have to be aware that this is on the one hand quite a new instrument uh and the non-compliances which were identified here are now really including the severe ones we even could uh name here a number the three percent But it includes also non-compliances which might only be a formality that that there was maybe some information lmm not not in the correct Place yeah so uh this we need to be aware and I think we have in the report quite more detailed information uh on non-compliances for specific obligations where we then can see uh this these figures uh drop once you then really focus on on specific um let's say relevant obligations of the uni holders uh the the quite interesting picture that we see with respect to the non-compliance is that uh the higher non-compliance rates are always related to Downstream user duties so for example we see uh that the substance inspections which are related to the uh use of a substance ing to the conditions of an authorization granted an actor Upstream in the supply chain that 26 percent of these cases uh are these are non-compliance so this is typically a non-compliance of a downstream user and then we also can see that again 26 non-compliance is there when it comes to the duty of the downstream user to now really identify and apply and if suitable also recommend measures to adequately control the identified risk during the use of the substance and another aspect is being discussed already the article 66 notification before so 20 or of the substance inspections revealed that there was not this article 66 notification in the database at the time of the inspection there are uh quite some favorite substances which show uh the highest non-compliance rates uh and this is uh for example the lead sulfacromate yellow where we have 63 percent of non-compliant cases for this substance or the strontium chromate with 51 percent and the chromium trioxide which has 35 percent an additional Point uh when it comes to the non-compliances was that the inspectors found in 35 percent of the cases that the communication about the information related to operational conditions risk management or monitoring Arrangement which are all included in the authorization decisions are actually not passed down the supply chain at the downstream users it was also observed that once this information is provided in the supply chain in form of the safety data sheet for example then the quality of this information was often poor and these two facts push the downstream users into a non-compliance because they are simply not aware what needs to be observed or or they are not well informed or only in a poor way they are informed and the downstream uses themselves uh they they are not aware and they even do not know that they by themselves actively should ask for better quality information from their suppliers in order to overcome this problem by getting active themselves right so quite a vicious circle then and hopefully now we'll talk with my check more about the recommendations later on to see how the situation can be improved yeah that that's really an important point and for the recommendations for us it was uh also quite interesting to see that uh when we checked for companies that uh really completely failed to observe the reach authorization duties they did not have a valid authorization they also did not have an application for authorization and there could not identify an exemption that could be applied for their use in their substance that such cases were quite low we only observed in three percent of the inspections that such Free Riders which completely ignore the provisions of the reach authorizations are there and here we really have to say that these are three percent are really a small proportion of the uh forty percent overall non-compliance which we could observe and uh can you please tell me how many substances does this three percent refer to and I noticed that in the report we don't mention the names of these substances or the companies involved can you tell me why this comes really from the fact that the three percent uh of cases are uh in figures 17 inspections and this is of course a very low number when you want to do uh further analysis and and you will end up with uh poor quality statistical information so so we rather didn't want to do that with that low number of of inspections um let's then move on to the types of companies and uses specifically that were checked can you tell me more about those yeah we really did not take any specific focus in terms of the company size so for example uh we ended up with 65 percent of the inspected companies which are small and medium-sized Enterprises but this just came out as a result we did not take a focus there uh we also did not per se focus on on a specific economic sectors but in the end we have seen that uh 83 percent of of the inspections focused on the manufacturing economic sector here we have to be aware that this also includes then the mixture formulators or the article producers and in this sector again the biggest group was the companies that do the metal treatment and the coating duplicate using the chromium compounds which were something like 30 percent of the inspection cases uh also in terms of Rich duties uh manufacturer import under representative Downstream user we really included all these kind of Duty holders uh but in the end ninety percent of the checks that we did were actually related to the downstream user role of the companies and in terms of the uses uh the checks were also quite broad we received the answer for 73 different uses which are related to granted authorization or applications for authorization and then they have also similar figure 63 different uses which were related to existing exemptions in the regulation so really also in terms of uses we had quite a broad uh focus in this project um well I mean the let's say the burning question that comes out of out of the results on the report for me and I'm sure many others is is there then a real risk to workers or consumers or both because of the non-compliances that were found I think in general we really have to be aware uh that these non-compliances with the authorization requirements mean that there may be a risk to the workers or to the environment for example when the downswing users do not take the appropriate measures uh to Auto correctly control the identified risk we also see that the inspectors once they identified a non-compliance stepped in and with different enforcement measures in these non-compliant cases asked to bring the situation into compliance well that brings us nicely actually to my next question so so what happened to these companies and downstream users that were found to be non-compliant now I mentioned measures and actions but you know were there penalties for example imposed yeah it is mainly when we just discussed that we have to bring the companies into compliance it's maybe not that the the main focus is on penalties but really to bring companies into compliance and we can see this also for those 203 cases of non-compliance which we identified that that for the majority of these cases 198 uh follow-up action was reported and this can be advices either of written or it can be orders it can be also then criminal complaints or fines and the most often implemented follow-up action was really the written advice uh followed then by the administrative orders were written from this can see it's really on inspectors informing companies how they come into compliance and sometimes even ordering the companies how they have to come into compliance which is I think in terms of the risk which we discussed before of course the important step to take okay thank you very much Oregan let's move on to you magic and more specifically the follow-up and recommendations for industry and the European commission um what are the main recommendations from the project on the EU level so for the industries the main recommendation from the project these two uh improve the communication on conditions of the use of the authorized substance and also of course for the use of the substance ing to the conditions of the restrictions must be more rigorously aligned with the conditions that are prescribed in authorization decision that is that is clearly the main the main finding and the recommendations from the project right and then lastly the commission uh who's writing the authorization decisions is recommended to improve the clarity and also uh maybe be a bit specificity of the authorization decisions and there's a couple of specific uh ideas that the inspectors have put forward firstly is that these decisions would really benefit uh from always identifying the responsible actor for the specific authorization condition because some uh conditions are directed only of the authorization holders others and downstream users so it would be good to make it Crystal Clear um in the text secondly the decisions should be in the national languages of all the countries where the affected companies are located uh so particularly for the Upstream authorizations should also be released in the languages of those countries where the downstream users uh who are using the substance are located so they can also refer to it in their own native language thirdly the duties for the supply chain communication um and the flowing of information between the authorization holder and the downstream user should also be ideally regulated in the authorization decision because it would definitely help to improve the communication in the supply chain and so also improve compliance fourthly there is a certain overlap between the existing legislation for example the uh occupational health and safety uh or the requirements coming from the environmental legislation and these legislations require for example monitoring Arrangements uh at the workplace or application of hierarchy of controls and it would be important that the authorization decisions actually explain and clarify these overlaps between these requirements and the conditions of the decision right and lastly for the monitoring Arrangements it would be good if the authorization decisions include a bit more details about the measuring method for the sampling and the and the laboratory analysis maybe then a bit more about what these recommendations would mean in practice for the different actors for the industry one of the most important ones is then for the suppliers and that of course includes the Upstream improvisation holders they should really improve the quality and completeness of the extent safety date sheets in order to include all the information about conditions of the use of the authorized substances so that they are clear they are very specific and they are given in a concise language that the downstream users can easily understand which requires of course um that the operational conditions the risk management measures and the monitoring conditions are explained uh in a clear language uh also addressing National exposure limits and doing so in a clear manner it is not a simple fit but it's really important uh aspect of the functioning of for authorization system and also this Improvement of communication from the suppliers this is the solution to break the circle that that you have referred to before and because if that stream users get clear information they'll be able to understand and Implement them and then use this uh use the substance in a safe way thus complying with the authorization conditions for the downstream users uh in practice well they need to ensure that they follow the operation conditions and the risk management measures set out in the authorization decision for the substance that they use if they find that any of this is unclear or vague and this this we have heard that this often happens for example there was a suggestion in the safety date sheet that emissions should be insignificant which could mean anything so if there are such such vague or unclear statements the dancers should clearly and and proactively seek clarification from from the supplier so they need to ask up the supply chain uh and it is really critical that the authorization conditions are followed um because even though the project findings indicate that you know this happens and the data streamers follow the on the conditions in three out of four uh cases it works in most cases but for the authorization Provisions this is all about substance of high concern so compliance ambition should really be at 100 percent we have a clear need of of improvement in this area for the commission let's say and the project lists a number of of suggestions of how the how to change the um writing of the authorization decisions and these changes uh would mean that the decisions will be uh clear and easier to understand and follow by the duty holders and also much easier to enforce okay thanks and I mean coming back to what Oregon said earlier about there being you know potentially risks from these because we are talking about some some harmful uh substances uh here so is is there anything that can be done in the short term to ensure that these authorization requirements are being followed and and also better enforced well the fastest fix that that could be done uh is is to improve the communication the supply chain uh between the authorization holders the suppliers and then the users of the substances and this of course uh requires clear information down the supply chain on the required conditions of use as just mentioned before but also uh it also means that the suppliers uh should and could proactively communicate with the downstream users not just through the extended safety date sheets as they are required to buy low but also using any other means just to make sure that the recipients know their duties and and know how to use the substances safely so this is definitely something that the suppliers can do and they should be ready to respond to requests for clarification from the downstream user so this this Improvement and then then maybe a more proactive approach uh is definitely something that could be done quickly in addition uh let's say as a follow-up to the project uh The Forum plans a dedicated workshop for the stakeholder organizations in in the in the second quarter of of this year in order to communicate results and recommendations from the project to the industry and stakeholders so we hope that this would facilitate and then Quicken the implementation of recommendations right and then how do you see this result impacting the ongoing discussions on the reach review looking at the future of authorization well it's a good question which is probably best addressed to the European commission at the moment who's working on the on the reef revision right now let's say what what we can say from the results of the project is that the results indicate a compliance situation point out the difficulties that that Oregon has has mentioned in the previous part of the podcast they show uh the challenges with the implementation of the existing provisions and also recommend remedial actions for the different actors the industry enforcement Echo and the commission so in addition to enforcing compliance The eka Forum projects are useful input to legislators by indicating how the legislation is implemented in practice maybe one finding that that's that's particularly uh maybe particularly relevant um is about the insufficient supply chain communication it may indicate that for any future mechanism for absolute authorizations special attention will be needed to ensure good flow information between authorization holders and the downstream users all in all I certainly hope that the findings and recommendations are from the project will be useful for the retrivision all right we've come to the end of our episode thank you both for joining us Oregon thank you for sharing your insights into the results and my check for going through the main recommendations and shedding some light on the next steps now for our listeners you can read the full report on our website at echo.europa.eu join us again in March where we'll be interviewing the chair of the Forum following their March meetings as well as our regular debriefs with the chairs of our risk assessment socio-economic analysis and biocidal products committees thanks for listening and stay safe for chemicals podcast sound science on harmful chemicals [Music]