CA-Nov15-Doc.7.4-rev1

61st meeting of Representatives of Members States Competent Authorities for the implementation of Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products

Overview of Member States Article 95 enforcement activities

Austria
In the last six months, our inspectors have informed and controlled several companies. The focus of the inspections was the manufacturers of biocidal products. No non-compliance was observed. At the time being our inspectors do not control products placed on the market, because of the German translation of Art. 95. We are waiting for the Corrigendum of the BPR.
In addition the CA receives declarations of conformity from companies.
In general the inspectors ask for more information especially for biocidal products in the transitional period and maybe it’s of interest that one inspector reported that the enforcement of Art. 95 has no priority because it’s only a regulation for a fair competition and not for the environment. Therefore we have to discuss and motivate our inspectors also.
Belgium
Belgium has an existing authorisation scheme for biocides under its national legislation. Therefore the BA CA has the contact details of all companies placing biocidal products on the market, and can easily contact them.
The Belgian CA sent in April 2015 letters to all current authorization holders, informing them about their obligations regarding Art. 95 (see attachment for a copy of these letter in Dutch and French). This was done for all products authorized according to the Belgian national scheme during the transitional period.
The authorisation/notification holders were asked to provide the following information on their active substance/product supplier before September 1st:
  • Full administrative details
  • For Belgian companies: CBE number
  • Evidence of a (commercial) contract between the company of the authorisation holder and the supplier/manufacturer of the active substance (signed and dated)
Regarding the evidence of a (commercial) contract, proofs of commitment such as a trade- or distribution agreement, a purchase order or an invoice (when signed and dated) were accepted. If the supplier of the active substance was not the direct point of purchase, commercial commitments from the supplier to the business of the authorization holder had to be demonstrated, including all intermediaries, or a direct statement from the supplier.
The BE CA received answers on 65 % of the concerned products.
The BE CA verify themselves whether the active substance/product supplier is compliant with Art. 95.
The received answers are still under treatment, and at this point a compliance rate of around 70 % is observed.
With the compliance check half-way, the BE CA is reflecting on how to proceed further with this, in order to get a higher compliance rate and to in the end remove the products from the intentionally non-compliant authorisation holders form the market. Until now, no actions of enforcement have been undertaken towards non-compliant companies.
Since the 1st of September, the BE CA does not issue any new authorisations under the national scheme during the transitional period if the concerned product does not comply with Art 95.
Bulgaria
The authorization in Bulgaria is implemented forall biocides,placed on the marketandused in territory of Bulgaria.Ministry of Health grants authorization at national procedure for the placing of a biocidal product on the market, under the transitional measure provided by Article 89 (2) of Regulation (EU) № 528/2012 and at proceduresunderRegulation (EU) № 528/2012.
Currently there are 1600 actual authorizations of biocidal products.
Ministry of Health put on the Internet site of the Ministry templates for self-declaration forms, before 1 September 2015, with recommendation to companies to filled in and submitted self-declarations to the Ministry.
Currently we received self-declarations by authorization holders, concerning 30 % of authorized products. These self-declarations are checked by us. The bigger parts of them are accompanied with supporting data. For another, where information is insufficient, we sent letters asking for clarifications. At the moment we still receive self-declarations.
For biocidal products that have not yet received declarations Ministry of Health prepare a list of persons placing on the market concerned biocidal products.These listswill be providedof regionalhealthinspectorates, toimplementactivitiesin the territorycontrolled bythem. The companies will be required to present documents showing compliance with Article 95(2) and accordingly, in case of non-compliance will be issued prescriptions to provide information and set deadline.
For biocidesthat have notbeen provento meet the requirements of Article 95, the Ministry of Healthwill begin toissue ordersto stopplacing on themarket of thebiocidal products.
Concerning products, for which submission for authorization for placing on the market after 1 September 2015 are met, before examination of submissions, Ministry of Health requires information about compliance with the provisions of Article 95(2) - both for biocides, authorized according Regulation (EU) No 528/2012 and under the transitional rules provided by Article 89 of the BPR.
Croatia
In Croatia all product types require approval under national legislation. The Croatian CA sent in May 2015 letters to all authorisation holders informing them about obligations regarding the Article 95. The letter contained also information about the evidence that is accepted as a proof of compliance (e.g. contracts, purchase order, invoices, statements of supplier).
From 1st of September new authorisations under the national scheme are not issued if proof of compliance with Article 95 is not submitted with application. We use the webform for application submission and in the webform mandatory filed is the name of active substance supplier and supporting documents should be uploaded. Self-declaration form and confirmation of supply form prepared by the Commission are accepted. They have been translated to Croatian and they are available on our website. For already authorised products, the authorisation holders are informed to prepare and keep all needed documents ready for inspection.
Products already on the market have not been checked for compliance, but it is our priority for 2016. During 2015 inspectors while checking compliance with legislation on chemicals were regularly informing companies about requirements on Article 95 to raise awareness. Until now measures were not taken against companies. At this moment we cannot provide non-compliance rate.
Denmark
The Danish MSCA has chosen to send out a paper mail regarding the article 95 to all the existing AH. The number of authorization holders is 71 at the moment. There has been a lot of replies on the mails and a lot of documentations proving the compliance with article 95 from the companies. We decide to archive all the information and will update all the received information next time the companies apply for changes to their products.
Estonia
On the 4th Feb. 2015 the information about article 95 were made available on the website of Estonian BPR Helpdesk.
On the 2ndMarch 2015 we start with a notification. We sent to all companies who have ever applied for authorisation/registration under transitional measures and under BPR a letter about art 95 requirements. Approx. 200 companies (113 of which located outside Estonia) received the notification letter.
Starting 1st Sept. 2015 all new applications for registration under transitional measures are being checked for Art 95 (2) compliance. Companies who are already on the market have not been checked for compliance so far.
Finland
Information on Article 95
Was on our BPR Helpdesk website from 1.9.2013
Stakeholders are informed about article 95 requirements in several seminars and meetings and by our electronic newsletter Biosinfo.
All relevant Helpdesk answers and personal contact letters for suppliers and sellers contain information about article 95 requirements.
Products authorized during the transitional period rules of BPR
In the summer 2015, the compliance of article 95 was checked from the present decisions of wood preservatives and slimicides (product types PT 8, 11 and 12), antifouling products PT 21, insecticides and repellents (PT 18 and 19) as well as rodenticides (PT 14).
All non-compliant authorization holders will receive a personal letter to remind about the article 95 requirements.
France
This provision that strongly impacts the market of biocidal products under the transitional period has been communicated to stakeholders via different ways by the French authorities : through national biocide stakeholders day (November 2014), participation of the French competent authorities to information sessions organized by representative organizations (1st half 2015), or through the replies done by our national helpdesk.
To inform again the economic operators of this regulatory deadline, a notice was published in the official journal of the French government (mid 2015) to recall the motivations of this new regulatory requirement and clarify its implementation modalities, with the links on the ECHA website.
Besides all the companies having placed on the French market a biocidal product under the transitional period (around 30 000 products) and so having complied with the mandatory registration on the French biocides database have been informed via an individual e-mail of these new requirements.
All these communications have recalled that Article 95 does not apply only to the first placing on the market but well at all the operations linked to the making available, and without any delay for the making available of stock.
The pragmatic approach proposed at the EU level, aiming at improving the awareness of persons responsible for the making available of biocidal products regarding this new requirements during first months after 1 September 2015, has been reminded to the inspector networks, in charge of the enforcement of environment and consumption and competition regulatory frameworks in France.
The control of article 95 is currently done as part of more generic enforcement activities dealing with chemical products.
Even if the French competent authorities have received some self-declarations, no mandatory submission of such documents in relation with article 95 is foreseen. We are currently discussing with our national consultative committee for biocides the way the documents proposed by commission services can be implemented and can be produced by operators along the supply chain, in order to ease the control of this requirement by our control bodies.
It should be noted that a number of returns have been communicated to us through our control bodies or our helpdesk on supply difficulties of some product manufacturers from authorized active substance suppliers.
Germany
The enforcement of the provisions of the BPR in Germany - including the enforcement of Article 95 - lies in the competence of each of the enforcement authorities of the 16 Federal States of Germany (Bundesländer). There is no central enforcement agency.
In the course of the discussion on enforcement of Article 95 in the previous CA Meetings we consulted the enforcement authorities of the Federal States and received some feedback. In that feedback the authorities indicated that the enforcement of the provision of Article 95 takes place as part of their general enforcement activities regarding Biocides. Therefore, information of the enforcement of Article 95 specifically and rates of non-compliance with that specific provision cannot be provided at this point in time.
Greece
As far as the implementation of art 95 of the Biocides Product Regulation in Greece, the Ministry of Rural Development and Food which the competent authority in Greece for PTs (8, 9, 10, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21) the following:
Greece has an existing legislation framework in place as regards the authorization of biocidal products during the transitional period. According to our national legislation, biocide dossiers must contain information about the manufacture(s) of the active substance(s) contained in the product including the relevant letters of supply.
All authorizations granted by our service, including transitional period ones, are uploaded to our authorizations database, which is publicly available through our web site.
In January 2015 a guidance document regarding the implementation of article 95 was prepared by our service on the basis of the discussions during the 58th CA meeting (November 2014) and was sent by email to all authorization holders and/or their contact points in Greece. Additionally this document was made publicly available through our web site. According to our guidance document, authorization holders of biocides that do not comply with article 95 provisions should submit by August 31st 2015 the latest, an application for change of the supplier/manufacturer of the active substance(s) of their authorized products. This change had to be accompanied by letter(s) of supply from companies listed on article 95 list (self declarations were not accepted). Also, authorization holders were reminded that no period of grace is allowed for making available to the Greek market the non-compliant products as of September 1st, 2015.
According to our records almost 160 out of approx. 800 authorized biocidal products belonging to the above PTs during the transitional period in Greece, did not comply with article 95 provisions. Our service received approx. 100 applications for change of the manufacture of the active substance until August 31st, 2015, whilst for the remaining biocidal products no applications were received or in the case that applications were received the supplier of the active substance was listed on the article 95 pending list. In order to avoid any mistakes the Greek CA is still in the process of cross checking the biocidal product authorizations in terms of article 95 compliance.
Our first priority is the withdrawal of the authorization licenses of the non compliant biocides. No period of grace will be allowed for the existing stocks on the market. We estimate that the withdrawals will be issued by the end of November or mid of December, 2015. Next, the Greek CA will proceed with the administrative changes, while the respective biocidal products can still remain on the market. However, it is an authorization holder’s obligation to have its active substance(s) source changed as of September 1st, 2015.
Ending, we would like to point out that companies listed on the article 95 pending list on September 1st, 2015, were excluded from the compliant ones since the only “legal” list is the official list produced by the Agency as it was also pointed in the Commission’s reply to our question seeking for clarification regarding the above matter.
Hungary
The document CA-May15-Doc.4.13 and the belonging Annex were the basis of the awareness rising program started in Hungary in summer. We decided to make a list about complying and “semi-complying” (when the confirmation of supply is missing because the supply chain is too long or complex) products and to implement this so called white list into the enforcement.
The tasks of the work program for the inspectors were identified in October and the enforcement of Article 95 is the top priority for 2016 regarding biocides. A practical guide is to be compiled till the end of November to help our inspectors regarding the tasks and questions in this subject, like the consideration of ECHA’s pending list. Any additional information that may arise at the next CA meeting will be included afterwards, if necessary.
In September every region centre were visited by the CA members where the Chemical Safety Inspectors were trained personally about Article 95 and other relevant topics like in situ actives and the transitional period.
Next year the region centres will be involved in training activities again, but this time it will be scheduled for April to provide additional support mainly focused on Article 95.
Generally we are trying to provide as much help centrally to our inspectors as possible.
The rate of compliance was acceptable, but there is no exact data. The awareness rising program was successful, even the small enterprises could be informed effectively. Though it is true that great efforts were done to contact all the main representatives of the Hungarian industry directly and inform the other stakeholders via print or digital media.
The rate of awareness was lower among the micro and small enterprises as it was estimated, but the period of grace could be long enough for them to comply with the provisions of Art95.
It shall be noted that processing the self-declarations was a hardly manageable workload for the CA and unfortunately it was quite a challenge for the small enterprises to obtain and provide the requested data correctly.
Ireland
In relation to enforcement activities relating to Article 95 the Irish CA has in 2015:
-At the beginning of January 2015 all product stakeholders (Notification Holders under national legislation and authorisation holders under the BPR) were informed by direct correspondence and via our website and LinkedIn group about the timelines and deadlines for compliance with Article 95. This has included a request to submit in relevant documentation to ensure compliance with Article 95 such as a letter of supply, letter of access, self-declarations.
-Since 1st March 2015 all notification applications for notification under national legislation require supporting documentation to ensure compliance with Article 95 such as a letter of supply, letter of access, self-declarations.
-Inspection activities in the Irish market at manufacturing locations since 1st September 2015 has included compliance aspects relating to Article 95. In particular, there is a focus on non-compliance relating to Article 95 where this is identified.