CA-March14-Doc.9.1
/ EUROPEAN COMMISSIONDIRECTORATE-GENERAL
ENVIRONMENT
Directorate A – Green Economy
ENV.A.3 - Chemicals
DraftCOMPOSITE REPORT
in accordance with
ARTICLE 24 of DIRECTIVE 98/8/EC concerning the placing of biocidal products on the market
Covering the period from December 2009 to November 2012
Table of Contents
1.INTRODUCTION
2.RESULTS
2.1.Information on poisonings
2.1.1.Answers provided by MS
3.ANNEXES
1.INTRODUCTION
Article 24 of the Biocides Directive 98/8/EC stipulates that Member States have to take the necessary arrangements to monitor their market and make sure it complies with the requirements of the Directive.
These arrangements, together with information on poisoning incidents involving biocidal products, should then be reported by each Member State to the Commission, by 30 November of every third year following the year of entry into force of the Directive (2000). The Commission, based on these reports, will then prepare and publish a composite report within a year. This will be the fourth round of reporting under Article 24 since the entry into force of the Directive.
On 22 May 2012, Regulation (EU) No 528/2012 of the European Parliament and of the Council concerning the making available on the market and use of biocidal products (BPR) was adopted. It repealed and replaced Directive 98/8/EC, and is applicable as of 1 September 2013. The Regulation was published on 27 June 2012.In the BPR, Article 65lays down the provisions with regard to monitoring and reporting activities addressing the implementation within the Member States. These include information on poisoning by biocidal products.
Given this new legislation and based on the information in the previous reports, no major changes in the Member States' current implementation status were to be expected. Therefore it was agreed in a meeting with the Biocides Competent Authorities in July 2012 to limit the data collection to poisoning information.
However, Member States were kindly invited to inform the Commission if other significant changes came up with respect to the national situation.
At the same time, the composite report will provide the stakeholders and the general public with a source of valuable information on these matters. In order to facilitate and harmonise the structure of reporting, the Commission prepared and sent to the Member States a questionnaire focussing on thestatistics on poisonings.
A majority of the Member States, Norwayand Switzerland sent reports following the Commission questionnaire format. No reports were received from Bulgaria, Cyprus, the Czech Republic, Greece, Ireland and Portugal.
2.RESULTS
2.1.Information on poisonings
The Member States were asked if they have appointed in accordance with Article 23 of the BPD, a body or bodies responsible for receiving information on biocidal products and for making such information available to them in cases of suspected poisonings, and if yes, to provide details (name and contact details of the body, the arrangements made to ensure the confidentiality of the product information).
In addition they were requested to provide information on the number of poisonings from biocidal products that were reported in their country in 2010-2012, as well as the type of product or substance involved. An overview of the poisonings per Member State can be found in Annex I to this report.
All Member States have appointed specific bodies responsible for collecting information on biocidal products in accordance with Article 23 of the BPD and making available this information in cases of suspected poisonings.
18 Member States and Norway and Switzerland reported specific arrangements which they have made to ensure the confidentiality of information provided by companies. In part of the cases, reference is made to national legislation providing measures to ensure confidentiality. Some Member States communicated the establishment of rules that allow the sharing of information only in cases of emergencies and/or medical purposes. Besides physical measures it was reported that the information is available in IT secured data bases, often only accessible by appointed professionals (e.g. staff, medical professionals,…).
However, based on the information we received it is not possible to draw a detailed graph about the number of poisonings and the product types involved. . It is not always clear whether these are linked to biocidal products, plant protection products, detergents, or products containing dangerous chemical substances in general.In addition some Member States reported the calls registered at the responsible body, which in the end do not necessarily imply poisonings.
Some Member States provided a breakdown according to the age of the exposure victims. This shows, maybe not surprisingly, that a significant number of the incidents are related to children. Some amount up to almost half of the intoxications reported.Some Member State contributions identified whether the exposure is due to accidents or to intentional self-harm. It turns out that voluntary exposure by biocides is rather limited.
Nevertheless, taking into account this information, it is possible to point out that a majority of the poisonings is related to the professional or household use of disinfectants, insecticides and rodenticides. Also repellents and wood preservatives are frequently mentioned. Where it was possible to identify the active substances, we can see that the following substances arerepeatedly involved: bromadiolone, brodifacoum, difenacoum, permethrin, pyrethrins and pyrethroids, sodium hypochlorite, organophosphates and carbamates…
Three Member States, the Netherlands, Spain and Sweden, have submitted information on animal poisoning. This reveals that rodenticides are the main intoxicants in the majority of the cases.
2.1.1.Answers provided by MS
In this chapter one can find the details of the responsible poison centres per Member State. In addition indication is provided on how confidentiality is maintained when handling the collected data.
Austria
Vergiftungsinformationszentrale für Österreich
Stubenring 6
A-1010 Vienna
Tel.: +43 1 4064343-0
This body was appointed in accordance with para. 27 (5) of the Austrian Act on BiocidalProducts, Federal Law Gazette I No. 105/2000
The current Act on Biocidal Products in Austria, Federal Law Gazette I No 105/2000,(see paras. 27 (5) and 33) as well as the new Act on Biocidal Products in Austria,Federal Law Gazette I No 105/2013, (see para. 9) legally obliges the body appointed to receiveinformation on biocidal products and tomake such informationavailable in cases of suspected poisoning.
The Vergiftungsinformationszentrale fürÖsterreich cannot make use of the data it receives from the Competent Authority, except for responding toany medical demand by formulating preventive and curative measures, inparticular in case of emergencies. In Austria it is therefore ensured by binding legal provisions(of administrative nature), that the body receiving information about biocidal productsdoes not use the information for other purposes. Additionally, it can be stated that because of thenature of the “Vergiftungsinformationszentrale für Österreich” as a non-profit, officialorganisation, and the internal procedures established within that body, confidentiality of the information received also in practical terms is ensured.
Belgium
Centre Antipoisons - Antigifcentrum
C/O Hôpital Central de la Base Reine Astrid
Rue Bruyn, 1
1120 Bruxelles
info@poisoncentre
.
The Belgian Royal Decree of 22 MAY 2003 concerning the placing on the market and use of biocidal products, article 44 ensures the confidentiality of the product information which is available by the Belgian Poison Control Center.
The Belgian Poison Control Center is a public utility foundation and is a member of the European Association of Poison Centres and Clinical Toxicologists.
Denmark
The responsible body in Denmark is;
Danish Poison Information Centre
”Giftlinjen” Bispebjerg Hospital, Denmark
Bispebjerg Bakke 23
2400 København NV
Tel./Fax: +45 35313999/ +45 35313999
Estonia
TheCompetent authority, responsible for receiving information on biocidal products and for making such information available in cases of suspected poisonings, is:
Poison Information Centre
Health Board
Postal address: Gonsiori 29, Tallinn 10147
Phone: (+372) 6269 390; Fax: (+372) 6269 371; E-mail:
The product information is handled as a trade secret and therefore is not released to outsiders. The collected information is used only for the purpose of medical advice in case of poisonings.
The Poison Information Database is accessible only for the Poison Information Centre´s employees and is protected by the security system ISKE on medium level: T2S2K2.
Finland
The Finnish Poison Information Centre is the appointed body for collecting data on poisonings.
Finnish Poison Information Centre, Helsinki University Central Hospital
P.O. Box 790 (Tukholmankatu 17), 00029 Helsinki, Finland
Phone: +358-9-471 977, Fax: +358-9-471 74 702
The Finnish Poison Information Centre has been receiving confidential product information both from commercial companies and the authorities for over 50 years, and has in place all necessary arrangements to ensure the confidentiality of information provided. These include: fully closed office spaces with access limited through electronic access control, dedicated databases only accessible for Centre Staff and situated within the firewall of the Helsinki University Central Hospital data systems. All staff health care professionals are used to handle confidential patient data. The training and work culture is in place to guarantee appropriate handling of confidential information.
No data can be made available from the Finnish Poison Information Centre on poisonings involving biocidal products in 2009-2012. Providing such data would require a special analysis of poison information centre call-data and retrieval of additional information is not possible with the current resources.
France
The INRS (Institut national de recherche et de sécurité) is responsible for receiving information about the full composition of biocidal products, in accordance with article 23 of directive 98/8/EC. Companies shall notify to INRS this information, which is stored in a database only accessible to Poisoning surveillance centers. This declaration shall preferably be made via the so-called Synapse website. This database can be consulted only by accreditedstaff from the antipoison centres and the INRS.
Contact details:
INRS
Département Expertise et Conseil Technique
Risques Chimiques
65 boulevard Richard Lenoir
75011 Paris
FRANCE
Germany
Federal Institute for Risk Assessment
Thielallee 88-92
14195 Berlin
Fax: +49-30-18412-4970
E-Mail:
State-of-the-art security measures (both, for physical and IT-security) have been put in place. Furthermore, by regulatory means, demands for information are strictly limited on a need-to-know basis.
Article 16e of the German Chemicals Act foresees that the details specified in paragraphs(1) and (2) of that article must be treated confidentially. This information may only be used for the purpose of handling medical enquiries and in replying to such by specifying preventive and curative measures.
Hungary
National Institute of Chemical Safety
Health Toxicology Information Service
Nagyvárad square 2.
H-1097 Budapest
Phone: +36 1 476 6464 or +36 80 20 11 99
The data and Safety Data Sheets in the national register are handled confidentially. Based on the data base in case of poisoning or emergency, information is given to the public about first aid.Health professionals can get information about first aid, the symptoms and hazards related to a specific product.
Italy
The 'Istituto Superiore di Sanità' is the body appointed in Italy, in accordance with Article 23, responsible for receiving information on dangerous biocidal products and for making such information available to the anti-poisoning centres, in cases of suspected poisonings (see point 2.1). The access to the database containing information on the products is restricted
Latvia
The body appointed in Latvia is the National Poison Control Centre, Hipokrāta iela 2, Rīga, LV-1038, phone number +371 67042473
Information on biocidal products registered under national requirements is publicly available,provided it does not contain confidential information. Regarding the composition of biocidal products – only active substance(s) and its concentration are published. The rest of the product composition is available through a data base in which companies have to submit their annual report on produced or imported chemicals and mixtures, including, biocidal products. There are only a few institutions which have access to this data base. The system requires a user name and password..
Lithuania
The appointed body in Lithuania is:
SveikatosapsaugosministerijosEkstremaliųsveikataisituacijųcentras (Health Emergency Situations Centre of the Ministry of Health),Birutėsstr. 56,LT-08110Vilnius, Lithuania, e-mail: , tel.:+370 5261 9888, fax: +370 5 231 4436,
Rules for collecting and disseminating information on human poisonings and their specific prophylactic properties arelaid down in Order No V-650 of 12th August 2005 of the Minister of Health. It is established thatinformation that can be disseminated about products may only contain advice on poisoning diagnostics, prevention, first aid measures and antidotes.
Luxembourg
In Luxemburg there is the Directorate of Health - Division of Pharmacy and Medicinal Products. The receiving body ispart of the administration, and as such it is considered that no further specific measures to ensure confidentiality should be needed
Malta
The responsible body in Malta is the 'Malta Competition and Consumer Affairs Authority' (MCCAA), Mizzi House, National Road, Blata l-Bajda, ĦMR9010,.
The manufacturer, importer, and/or trader, responsible for placing the product on the market shall send to the MCCAA information related to the full chemical composition, intended uses, type of use and general characteristics of the product.
By having this data bank, the MCCAA can contribute to the Medicines and Poisons Information Section, at Mater Dei Hospital (MDH-Malta), by allowing access to the information for health prevention purposes and for toxicological emergencies. MCCAA shall guarantee the industry the necessary confidentiality of the information stored in the archive, hence the Medicines and Poisons Information at MDH, who will have access to the archive, shall ensure an acceptable level of confidentiality as well.
Netherlands
Nationaal Vergiftigingen Informatie Centrum (NVIC)
(National Poisons Information Center)
University Medical Center Utrecht
PO Box 85500
3508 GA Utrecht
The National Poisons Information Centre (NVIC) of the Netherlands is appointed by the government as Article 23 body for receiving information on biocidal products. As a consequence the government guidelines on information security apply to this task of the NVIC. In addition, also information security arrangements of the University Medical Centre Utrecht are installed. Together these guidelines provide the necessary technical and procedural arrangements to ensure confidentiality of the product information. They are incorporated in the quality system of the NVIC
Poland
According to the Article 49 of Act of 13 Sept 2002 on biocidal products (Dz.U. z 2007, Nr 39, item 252 ), the toxicological centres specified by the Minister of Health acting in accordance with the regulation, are obliged to monitor the poisoning with biocidal products.
In the Minister of Health Regulation of 29 Aug 2006 on register of toxicological centres responsible for control of poisoning with biocidal products and on subjects obligated to report poisoning with biocidal products (Dz.U. Nr 161, item 1143 with amendments) the fallowing Toxicological Centres were established as responsible for control of poisoning with biocidal products in Poland:
- Niepubliczny Zakład Opieki Zdrowotnej
Pomeranian Toxicological Center,
ul. Kartuska 4/6,
80-104 Gdańsk - Poison Information Center
Collegium Medicum, Jagiellonian University,
Krakowski Szpital Specjalistyczny
Os. Złotej Jesieni 1;
31-826 Kraków - Center of Toxicological Information,
Oddział Toksykologii i Chorób Wewnętrznych,
Zespół Opieki Zdrowotnej Poznań-Jeżyce,
Szpital im. Franciszka Raszei,
ul. Mickiewicza 2;
60-834 Poznań - Office of Toxicological Information,
III Oddział Wewnętrzny z Pododdziałem Toksykologii,
Szpital Praski p.w. Przemienienia Pańskiego,
Al. Solidarności 67,
03-401 Warszawa.
The above centres are supplied by the Office for Registration with data on biocidal products authorised in Poland.
Documentation of reported cases of poisoning biocidal products is available only for CA.
Romania
The cases of poisoning with biocidal products in Romaniaare collected by the Centre for Poisoning Information (Office for International Sanitary Regulation and Toxicological Information, NIPH Bucharest) and the Forensic Health Care Institute - Toxicology Laboratory.
Slovakia
The appointed bodies in Slovakia are:
Univerzitná nemocnica Bratislava,
Pažítková 4
821 01 Bratislava
Národné toxikologické informačné centrum
pracovisko: Nemocnica akad. L. Dérera, Limbová 5, 833 05 Bratislava tel: +421 2 54774166, +421 2 54774605 (fax), mobil: 0911 166 066 email: ,
The arrangements to ensure the confidentiality of the product information are in line with the provisions of Art. 15 of the Act No. 217/2003 Coll. Furthermore, confidential data are available exclusively upon request for medical doctors for treatment of specific poisonings.
Slovenia
The Poison Control Centre in Slovenia is the:
University Medical Centre Ljubljana (UMCL)
Tel: +386 1522 5283, F: +386 1434 7646
The Chemicals Office of the Republic of Slovenia has granted access to the Information System for Chemicals - database on chemicals (which includes also biocides) for the Poison Control Centre. Only employees of the Poison Control Centrecan use these data in case of poisoning.
Spain
The Dirección General de Salud Pública, Calidad e Innovación of Ministerio de Sanidad, Servicios Sociales e Igualdad is the body responsible for receiving information on biocidal products, both for those products subjected to compulsory registration in accordance with the national system and for those under the national system's regulations. Nevertheless, information about the biocidal products that do not require registration at a national level during the transitional period is also sent directly to the Instituto Nacional de Toxicología.
For the registered products, this information is made available to the Instituto Nacional de Toxicología who, through their Toxicological Information Service, gives information (on the phone) about first aid.
In addition, we have a National Network of Surveillance, Inspection and Control of Chemical Products which acts at two levels:
a)As a warning network against irregularities in the rules in marketing (Rapid Exchange of Chemical Products’ Information System)
b)A toxicological surveillance system of voluntary declaration of cases of poisoning or accidents with chemical products attended in the Emergency Units of Hospitals
The system of gathering information is structured to be able to gather information about dangerous substances and chemical preparations in general.
The Real Decreto 1054/2002, which implements the Directive 98/8/CE, establishes the confidentiality of the available information.
Sweden
Swedish Poisons Information Centre
SE- 171 76 STOCKHOLM
The product information is kept strictly confidential according to the Swedish secrecy law, SFS 1988:9, 8 chapter 12§ and is only used for evaluation of acute toxicity. In the information service the product composition is never revealed except in those cases it is of importance for medical reasons to inform a physician about the ingredients that will influence the treatment
United Kingdom
The UK’s National Poisons Information Service (NPIS) is the Department of Health approved, and Health Protection Agency (HPA) commissioned national service that provides expert advice on all aspects of acute and chronic poisoning. The Service comprises four individual Units, based in Birmingham, Cardiff, Edinburgh and Newcastle.