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CA-March14-Doc.9.1 EUROPEAN COMMISSION DIRECTORATE-GENERAL ENVIRONMENT Directorate A – Green Economy ENV.A.3 - Chemicals Draft COMPOSITE 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 1

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EUROPEAN COMMISSIONDIRECTORATE-GENERALENVIRONMENTDirectorate A – Green EconomyENV.A.3 - Chemicals

Draft COMPOSITE 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

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Table of Contents

1. INTRODUCTION...............................................................................3

2. RESULTS............................................................................................. 3

2.1. Information on poisonings...............................................................32.1.1. Answers provided by MS.............................................................4

3. ANNEXES...........................................................................................14

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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 It repealed and replaced Directive 98/8/EC, and is applicable as of 1 September 2013.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 65 lays 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 the statistics on poisonings.

A majority of the Member States, Norway and 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).

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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 are repeatedly 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

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A-1010 Vienna

Tel.: +43 1 4064343-0

This body was appointed in accordance with para. 27 (5) of the Austrian Act on Biocidal Products, 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 receive information on biocidal products and to make such information available in cases of suspected poisoning.

The Vergiftungsinformationszentrale für Österreich cannot make use of the data it receives from the Competent Authority, except for responding to any medical demand by formulating preventive and curative measures, in particular in case of emergencies. In Austria it is therefore ensured by binding legal provisions (of administrative nature), that the body receiving information about biocidal products does not use the information for other purposes. Additionally, it can be stated that because of the nature of the “Vergiftungsinformationszentrale für Österreich” as a non-profit, official organisation, 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, DenmarkBispebjerg Bakke 23

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2400 København NVTel./Fax: +45 35313999/ +45 35313999

Estonia

The Competent 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 10147Phone: (+372) 6269 390; Fax: (+372) 6269 371; E-mail: [email protected]

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 accredited staff from the antipoison centres and the INRS.

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Contact details:INRSDépartement Expertise et Conseil TechniqueRisques Chimiques65 boulevard Richard Lenoir75011 Paris FRANCEwww.declaration-synapse.fr.www.inrs.fr

Germany

Federal Institute for Risk AssessmentThielallee 88-9214195 BerlinFax: +49-30-18412-4970E-Mail: [email protected]

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 SafetyHealth Toxicology Information ServiceNagyvárad square 2.H-1097 BudapestPhone: +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

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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:Sveikatosapsaugosministerijos Ekstremaliųsveikataisituacijųcentras (Health Emergency Situations Centre of the Ministry of Health), Birutės str. 56,LT-08110 Vilnius, Lithuania, e-mail: [email protected], tel.:+370 5261 9888, fax: +370 5 231 4436, http://www.essc.sam.lt/en/activities.html.

Rules for collecting and disseminating information on human poisonings and their specific prophylactic properties are laid down in Order No V-650 of 12 th August 2005 of the Minister of Health. It is established that information 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 is part 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 UtrechtPO Box 855003508 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

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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:

1. Niepubliczny Zakład Opieki Zdrowotnej Pomeranian Toxicological Center, ul. Kartuska 4/6, 80-104 Gdańsk

2. Poison Information CenterCollegium Medicum, Jagiellonian University, Krakowski Szpital Specjalistyczny Os. Złotej Jesieni 1; 31-826 Kraków

3. Center of Toxicological Information, Oddział Toksykologii i Chorób Wewnętrznych, Zespół Opieki Zdrowotnej Poznań-Jeżyce, Szpital im. Franciszka Raszei, ul. Mickiewicza 2; 60-834 Poznań

4. 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 Romania are collected by the Centre for Poisoning Information (Office for International Sanitary Regulation and Toxicological

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Information, NIPH Bucharest) and the Forensic Health Care Institute - Toxicology Laboratory.

Slovakia

The appointed bodies in Slovakia are:

Univerzitná nemocnica Bratislava,Pažítková 4821 01 Bratislava

Národné toxikologické informačné centrumpracovisko: Nemocnica akad. L. Dérera, Limbová 5, 833 05 Bratislava tel: +421 2 54774166, +421 2 54774605 (fax), mobil: 0911 166 066 email: [email protected], www.ntic.sk

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 Centre can 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)

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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 CentreSE- 171 76 STOCKHOLMwww.giftinformation.se

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.

NPIS gathers information on poisoning incidents that will include biocides, and is responsible for receiving and disseminating safety information on a range of products including biocides.

Contact details and address are given below.

NPIS (Birmingham Unit)City HospitalBirminghamB18 7QHUK

Tel: +44 (0)121 507 4123

Norway

Information on all biocidal products has to be submitted to the authorities’ central register of chemical products, the Product Register. Contact details are as follows:

The Product Register P.O. Box 8100 Dep

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0032 Oslo, NorwayTel: +47 22 57 34 00Fax: +47 22 67 67 06e-mail: [email protected]

Confidentiality of the product information in the register is ensured through Security Routines established by the Ministry of the Environment. Further information on this can be found at the website of the Product Register (http://www.klif.no/no/english/english/The-Product-Register/ )

The Norwegian Poison Information Centre under the Norwegian Directorate of Health is the central unit for the registration of poisonings in Norway. The Norwegian Poison Information Centre has access to the information stored in the Product Register

Switzerland

Responsible body for receiving information on biocidal products:

Common notification authority for chemicals of FOEN - FOPH - SECO

CH-3003 Bern

Tel. +41 31 323 16 48

Fax +41 31 323 54 86

email: [email protected]

www.bag.admin.ch/notificationauthoritychem

Responsible body for making available information on biocidal products in cases of suspected poisonings:

Swiss Toxicological Information Centre

Freiestrasse 16

CH-8032 Zurich

Tel.: +41 44 251 51 51

Fax: +41 44 252 88 33

email: [email protected]

www.toxi.ch

In Switzerland, the legal basis to ensure confidentiality regarding information on biocidal products is Article 33 and 34 of the Ordinance on Biocidal Products (OBP, SR 813.12), as well as Article 30 of the Chemicals Act (ChemA, SR 813.1)

To ensure an individual assessment of risk and adequate treatment advice in case of emergency, selected experts of the Swiss Toxicological Information Centre have full

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access to confidential product information, such as product composition. At the same time, a clear Confidentiality Policy was implemented. Confidential information is not given to any unauthorised person outside of the Information Centre.

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3. ANNEXES

ANNEX I

Details on poisonings in the Member States.

Austria

In the time period between January 1st, 2010 and end of 2012, there have been 5 cases of poisoning involving biocidal products recorded in Austria via the National Poison Information Centre mentioned above. In two cases accidently disinfectants and algicides (PT 2) have been swallowed or caused contamination of eyes, resp. The substances involved in these cases are Didecyldimethylammoniumchloride and Benzalkonium chloride, resp. In two cases the accidental inhalation of a wood preservative (PT 8) caused headache (active substance: Flufenoxuron). Another case involved the swallowing of a rodenticide (PT 14) containing the active substance Chlorophacinon causing very slight symptoms..

Belgium

The Belgian Poison Control Center does register calls after exposure to products. It is not sure that every registered exposure would result in symptoms of poisoning. The mentioned figures are not exhaustive because the communication of cases of poisoning to the Poison Control Center is not obligatory in Belgium. Products for domestic use containing hypochlorite are not taken into account. However exposure to this kind of products is very frequent (1000 calls/year)

2009 2010 2011 2012

Number of biocidal products implicated in calls after exposure

740 733 872 967

Parasiticides 345 375 417 443

insecticides 394 386

repellents 23 54

Protection products 85 68 76 50

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Disinfectants and general biocides

12 31 107 178

Rodenticides 275 259 272 297

Anticoagulants 167 156

Other rodenticides 7 5

Not specified 115 136

Other biocidal products

11 1 * 2

Number of persons exposed

adults 396 382 432 419

children 433 362 408 (74% of which under the age of 5 years)

510 (75% of which under the age of 5 years)

Denmark

Table. Inquiries to the Danish Poison Information Centre about poisoning with biocides and disinfectants 2010-12. The table gives absolute numbers (n) and proportion of all inquiries belonging to a given group.

2010 2011 2012

Inquiries (total) 18.127 19.584 20.851

n % n % n %

Insecticides 50 0.3 41 0.2 54 0.3

Rodenticides 6 - 7 - 5 -

Other and unspecified 31 0.2 35 0.2 51 0.2

All biocides 81 0.4 83 0.4 110 0.5

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Disinfectants with chlorine

93 0.5 123 0.6 134 0.6

Other disinfectants 114 0.6 122 0.6 134 0.6

All disinfectants 207 1.1 245 1.2 268 1.3

Estonia

Only information for product types 14, 18 and 19 is available. At the moment there are no statistics for other product types.

The difference in cases over years can be explained with lengthening of hours of service (up to 24/7 since 01.12.2012) and rising awareness among the general public.

2009 in total 6 cases:

Number of poisonings Product type Active substance involved

1 14 unknown

2 18 N,N-diethyl-m-toluamide

(CAS no 134-62-3)

2 18 Pyrethrins and Pyrethroids

(CAS no 8003-34-7)

1 19 Pyrethrins and Pyrethroids

(CAS no 8003-34-7)

2010 in total 14 cases:

Number of poisonings Product type Active substance involved

2 14 Difethialone

(CAS no 104653-34-1)

2 14 unknown

1 18 Deltamethrin

(CAS no 52918-63-5)

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2 18 N,N-diethyl-m-toluamide

(CAS no 134-62-3)

5 18 Pyrethrins and Pyrethroids

(CAS no 8003-34-7)

2 19 Pyrethrins and Pyrethroids

(CAS no 8003-34-7)

2011 in total 38 cases:

Number of poisonings Product type Active substance involved

1 14 Brodifacoum

(CAS no 56073-10-0)

9 14 Bromadiolone

(CAS no 28772-56-7)

1 14 Chloralose

(CAS no 15879-93-3)

13 14 unknown

8 18 N,N-diethyl-m-toluamide

(CAS no 134-62-3)

1 18 Permethrin

(CAS no 52645-53-1)

4 18 Pyrethrins and Pyrethroids

(CAS no 8003-34-7)

1 19 Pyrethrins and Pyrethroids

(CAS no 8003-34-7)

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2012 in total 30 cases:

Number of poisonings Product type Active substance involved

4 14 Bromadiolone

(CAS no 28772-56-7)

1 14 Chloralose

(CAS no 15879-93-3)

7 14 unknown

1 18 Disodium tetraborate decahydrate

(CAS no 1303-96-4)

2 18 Chlorpyrifos

(CAS no 2921-88-2)

2 18 N,N-diethyl-m-toluamide

(CAS no 134-62-3)

2 18 Permethrin

(CAS no 52645-53-1)

9 18 Pyrethrins and Pyrethroids

(CAS no 8003-34-7)

1 18 Tetramethrin

(CAS no 7696-12-0)

1 19 unknown

Finland

No data can be made available from the Finnish Poison Information Centre on poisonings involving biocidal products in 2010-2012. Providing such data would require a special analysis of poison information centre call-data and retrieval of additional information is not possible with current resources.

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France

The National Database of Products and Preparations (BNPC) is the reference data base for substances referred to in dossiers and requests for information from anti poison and toxic vigilance centres (CAPTV). To access information on cases of exposure, it was necessary to perform a comparison of the data collected by the Ministry of Ecology (MEDDE) in the context of the mandatory declaration by industry of their biocidal preparations, with data available in the BNPC. Here the data are mainly collected through the notification of biocidal products via the submission portal, the so-called “Déclaration-synapse”.

The BNPC identified 4790 different substances associated with exposure records; distribution in the 23 categories of biocidal products defined by Directive 98/8/EC are given in the following table.

Category NumberPT- 01 — Human hygiene biocidal products 305

PT- 02 — Private area and public health disinfectants and other biocidal products 2.069PT- 03 — Veterinary hygiene biocidal products 259PT- 04 — Food and feed area disinfectants 1 005PT- 05 — Drinking water disinfectants 110PT- 06 — In can preservatives 90PT- 07 — Film preservatives 14PT- 08 — Wood preservatives 167PT- 09 — Fibre, leather, rubber and polymerised materials preservatives 22PT- 10 — Masonry preservatives 155PT- 11 — Preservatives for liquid-cooling and processing systems 148PT- 12 — Slimicides 110PT- 13 — Metalworking fluid preservatives 47PT- 14 — Rodenticides 271PT- 15 — Avicides 0PT- 16 — Molluscicides — 0PT- 17 — Piscicides 0PT- 18 — Insecticides acaricides and products to control other arthropods 809PT- 19 — Repellents and attractants 224PT- 20 — Preservatives for food or feedstocks 0PT- 21 — Anti-fouling products — 11PT- 22 — Embalming and taxidermist fluids 9PT- 23 — Control of other vertebrates 9

The previous study (1999-2009) covered only 1499 substances. This significant increase is mainly due to the further comparison of the BNPC and MEDDE data (MEDDE), and the rise in the number of mixtures (formulations) contained in the latter, because of an increasing registration during the period 2010-2012.

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18.350 cases were identified concerning at least one biocidal product clearly identified for the period 2010-2012 (3,39 % of cases). In the previous report (1999-2009), only 5.762 files were related to biocides. The substantial increase is mainly due to better identification of substances as being biocides.

Exposure to biocides was reported in 17.285 cases or in 94% of cases (91,7% over the period 1999-2009). The remaining cases are classified as enquiries on biocidal products.

Sixteen thousand nine hundred and six (16.906) cases (97,8% of cases of exposure) were human exposures concerning 18.143 persons.

Nine thousand three hundred thirty (9.330, of which 550 related to collective exposure) of them (51,4 %) were symptomatic. People for which the no relationship was found between the effects and the exposure are excluded. 14 deaths were observed (mortality: 0,08%). The percentage of symptomatic cases was in the same order of magnitude (48,7 %) in the previous study (1999-2009). Mortality is slightly higher (0,13 %) but the difference is not statistically significant (p = 0,30).

At least 8 of the 10 deaths for which the imputability to exposure to a biocide is at least possible (I 1) are associated to voluntary exposure (suicidal corrosive substances). The products involved are unblocking agents based on sodium hydroxide in 5 cases, disinfectant solutions based on quaternary ammonium compounds in 3 cases and calcium removing of hydrochloric acid in 2 cases.

The following table shows the evolution of notifications of human exposure to biocides and in relation with all the notifications of exposure, as available in the national database of intoxication (BNCI), during the period 2010-2012.

Year (1st call) All exposures Exposures to biocides Exposure ratio (biocides/exhibitions). 100

2010 163 237 4 890 3,00

2011 190 414 6 243 3,28

2012 188 724 7 010 3,71

Total 542 375 18 143 3,35

The annual number of events is much larger than in the previous period, but as stated above, this is probably not an increase in the number of cases of exposure, but rather a gradual improvement in the coherence between the database of BNPC and MEDDE. In addition there is an increased notification by industry through the MEDDE data base, leading to a higher number of products registered in that system.

Categories of biocides most often involved are the disinfectants PT- 02 (Private area and public health disinfectants and other biocidal products: 49,2%), the PT- 18 (insecticides and acaricides and products to control other arthropods: 18,2%), the (PT- 04 food and feed area disinfectants : 17,5%) and the (PT- 01 Human hygiene biocidal products 15,9 %). This distribution is quite different compared to the one observed during the

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previous period. At that time exposure to Insecticides and Acaricides was less frequent and exposure to rodenticides was more common. (Both in absolute and relative numbers). These variations must be understood with caution, for the reasons already indicated above (development of the database of MEDDE and established comparabilities between this database and BNPC). Strangely there is fall in the number of cases of exposure to rodenticides (- 24%), although more products have been registered (271 in 2010-2012 to 136 in the previous period). Reason is that most of the files in this category have not been encoded during the period considered on basis of the mixture but on the main substance (usually because the information was not accessible: product which had been unpacked or without any indication on commercial primary packaging). This artificially lowers the number of people exposed to this category of biocide.

Between the two periods, there is however an overall reduction of 6,2% of cases related to rodenticides and subclasses, taking all products together. This decrease is mainly due to lower consultations from health professionals regarding cases involving anticoagulant rodenticides.

 

PT Number of people exposed1

Percentage Change over the period 1999-2009

PT-01 2883 15,9 +455 %

PT-02 8917 49,2 +362 %

PT-03 381 2,1 +163 %

PT-04 3168 17,5 +204 %

PT-05 228 1,3 +1325 %

PT-06 17 0,1 +31 %

PT-07 1 0,01 0 %

PT-08 336 1,9 +158 %

PT-09 36 0,2 +1100 %

PT-10 240 1,3 +238 %

PT-11 187 1,0 +163 %

PT-12 234 1,3 +1131 %

PT-13 12 0,1 +9 %

PT-14 871 4,8 -24 %

1 The total number of cases, obtained by totalling the effective poisonings for each PT exceeds 18.143 (100%), because many commercial products are registered in several PTs.

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PT-15 0 -

PT-16 0 -

PT-17 0 -

PT-18 3297 18,2 +447 %

PT-19 568 3,1 +1435 %

PT-20 0 -

PT-21 11 0,1 +266 %

PT-22 12 0,1 +20 %

PT-23 13 0,1 +550 %

The same phenomenon of progressive increase is observed at different scales in all categories of biocidal preparations where a sufficient number of notifications is available to consider a reliable development. The PTs are grouped in accordance with the number of poisonings:

·PT- 1, 2, 4 and 18: More than 2.880 exposed persons,

·PT- 3, 8, 14 and 19: Between 330 and 2.879 exposed persons,

·PT- 5, 10, 11 and 12: Between 180 and 329 exposed persons,

·PT- 6, 9, 22 and 23: Between 12 and 179 exposed persons,

·PT- 7, 13 and 21: Between 1 and 11 people exposed.

Over the whole period, 16.931 out of the 18.143 exposures reported to the CAPTV are accidental (93%), 1.132 are voluntary (6%) and 80 are undefined. For exposures from non-biocidal substances, during the same period, the respective shares of the accidental and voluntary circumstances is 83% (434617/522518) and 16% (82751/522518). Exposures to biocides are therefore significantly less often voluntary < (P 0,001). As expected, medicinal poisoning represents an important share of voluntary exposure. Moreover this type traditionally occurs more often than other exposures to toxic substances.

The ratio between voluntary and accidental exposures is roughly stable over the period of the study, the accidental poisoning represents around 92,7% to 93,6% of the cases where the circumstances of exposure are known.

Most categories of biocidal products are involved in most accidental exposures. The only exception is the PT- 23 (control of other vertebrates), with 54% of accidental and 46% of

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voluntarily exposures. But since PT- 23 involves just a small number of cases (13), this should be taken with caution.

9.330 of the 18.143 cases of exposure to biocides (51%) were symptomatic. The proportion of symptomatic cases after exposure to substances other than biocides during the same period was only 40% (210.013/522.518). This difference is statistically significant (P < 0,001).

In fact, the proportion of symptomatic cases varies between product types. Rodenticides (PT- 14), repellents and attractants (PT- 19) and human hygiene biocidal products show to be less frequently at the origin of symptomatic exposure. They do not entail major symptoms to at least 40% of exposed persons. Those which cause unrest amongst more than 60% of the exposed persons are: embalming and taxidermist fluids (PT- 22), the veterinary hygiene biocidal products (PT- 03), the drinking water disinfectants (PT- 05), in can preservatives (PT- 06), wood preservatives (PT- 08), masonry preservatives (PT- 10), slimicides (PT-12), anti-fouling products (PT-21), food and feed area disinfectants(PT-04) and the metalworking-fluid preservatives (PT-13). These observations are in line with the risks of the concerned active substances in each of these categories and/or (e.g. raticides) with the concentration to which they are present in the formulations.

The 14 cases of death are associated with exposure to preparations of disinfectants PT- 02 (private area and public health disinfectants and other biocides; 10 cases), PT- 04 (food and feed area disinfectants, 1 cases), PT- 14 (rodenticides, 1 case), PT- 18 (insecticides, acaricides, 2 cases).

Nine out of the 10 deaths showing a clear relationship to the product, concerned exposure to products belonging to PT- 02, which shows that this category of biocidal products is toxicologically very heterogeneous, since also less than 60 % of overall exposures to substances of this group was symptomatic.

Eight thousand seventy eight (8.078) of the 16.931 cases of accidental exposure to biocides (47,7%) and 657 of the 1.132 (58%) of the voluntary intoxications were symptomatic. The risk of symptoms is therefore significantly higher, when exposure is voluntary. Of 10 deaths with possible imputability (>1), in this series, 8 resulted from voluntary poisoning.

Mortality by biocidal products in this series is 0,08% (14 deaths per 18.143 cases of exposure to biocides). During the same period for all other cases dealt with by the CAPTV, mortality was 0,25% (1.284 deaths out of 504.375 cases of exposure, all substances combined). This difference is statistically significant: Exposure to biocides (all PT) result less frequently into fatal incidents than exposures to other agents (P < 0,001).

This study certainly underestimates the number of cases of exposure to biocidal preparations notified to the CAPTV in France. Indeed, it only took into account the declarations of biocides formulations to the Ministry of Ecology and present in the BNPC, excluding all those reported to the Ministry under a different name. In addition it excludes those which are not yet approved by the Ministry and those which have been

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withdrawn from the market before the reporting obligation, but that still can cause exposure.

Germany

Detailed annual reports of all poisoning cases notified to the German poisoning centre (PC) can be found on the website of the Federal Institute for Risk Assessment (BfR) under the following link:

http://www.bfr.bund.de/en/publication/brochures_and_leaflets-61045.html

The data of 2011 and 2012 are under evaluation and will be available in the course of the year 2013.

As Germany had not implemented a general authorisation procedure for existing biocidal products in the past, poisonings with these products have not been categorized as such until 2010. In the following those categories are specified that are deemed to either consist of or include biocidal products (and classified according to the Poisoning severity score):

Table 1: Poisonings involving biocides reported in 2009

Group of products Minor Moderate

Disinfectants/sterilizers 378 10

Acaricides 0 0

Wood preservatives 5 0

Insecticides 20 0

Carbamates 1 0

Phosphoric esters 9 0

Pyrethroids 2 0

Repellents 0 0

Rodenticides 4 0

Anticoagulants 2 0

Phosphine derivatives 0 0

Total 407 10

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Table 2: Poisonings involving biocides reported in 2010

Group of products Minor Moderate

Disinfectants/sterilizers 331 14

Acaricides 1 0

Wood preservatives 2 0

Insecticides 35 0

Carbamates 0 3

Phosphoric esters 6 0

Pyrethroids 12 0

Repellents 2 0

Rodenticides 4 0

Anticoagulants 1 0

Phosphine derivatives 5 0

Total 373 14

Table 3: Overall number of reported poisonings involving biocides in 2009-2010

Group of products Minor Moderate

Disinfectants/sterilizers 709 24

Acaricides 1 0

Wood preservatives 7 0

Insecticides 55 0

Carbamates 1 3

Phosphoric esters 15 0

Pyrethroids 14 0

Repellents 2 0

Rodenticides 8 0

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Anticoagulants 3 0

Phosphine derivatives 5 0

Total 780 24

Hungary

It must be mentioned that the recent Hungarian data base (KBIR) does not make it possible to extract the poisonings caused exclusively by biocidal products. There is no category system developed especially for biocidal product types, which means it can not be guaranteed (except hypo) that one or another category of KBIR covers exclusively biocidal products. Therefore the table below is only informative since it covers the announcements where there was an indication for the use of the product.

2009

Product type number of cases

active substance (not known in each case)

12 144 sodium hypochlorite, didecyl dimethyl ammonium chlroride,

trichlorisocyanuric acid345678 3 boric acid9 2 dimethyl fumarate1011121314 81 bromadiolone, brodifacoum15161718 22 chlorpyriphos, permethrin, d-phenothrin, tetramethrin, other

pyrethroids19 6 diethyl toluamide20 1 sodium benzoate212223

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2010

PT number of cases

active substance (not known in each case)

1 12

160sodium hypochlorite, benzalkonium chloride, glutaraldehyde, formaldehyde, trichlorisocyanuric acid

34567891011121314 42 bromadiolone, brodifacoum15161718 19 S-methoprene, deltamethrin, tetramethrin, other pyrethroids19 3 prallethrin, citriodiol20212223

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2011

PT number of cases

active substance (not known in each case)

1 22 142 sodium hypochlorite, alkyl dimethyl benzalkonium chloride345678 191011121314 89 bromadiolone, warfarin15161718 18 d-phenothrin, pyrethroids19 10 picaridin, diethyl toluamide20212223

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2012

Product type

number of cases

active substance (not known in each case)

1 12 169 sodium hypochlorite, trichlorisocyanuric acid345678

4

boric acid, potassium-(E,E)-hexa-2,4-dienoate, alkyl(C12-C16)-N,N-dimethyl-N-benzyl-ammonium-chloride

910111213214 98 bromadiolone15161718 32 pyrethroids, d-phenothrin, tetramethrin19 4 prallethrin, diethyl toluamide20212223

Italy

Currently only data for 2007-2009 are available.

Between 2007 and 2009, the National Information System on Pesticide-related Injuries and Poisonings (NIS-PRIP) identified 6,210 human cases of unintentional exposure to biocides. These cases were all notified to NIS-PRIP by the National Poison Control Center in Milan. Most of the patients (73%, 4,542) were asymptomatic. Some 27% (No. 1,668) developed at least one sign/symptom possibly related to the reported exposure and were classified as cases of biocide-related poisonings. Severity of clinical effects was low in 90% of cases (No. 1,484) and moderate in 11% (No. 178 cases). Six cases suffered severe effects. No cases of deaths were observed. Most of the patients were exposed at home (76%, No. 1,267). Occupational and environmental exposures were reported for 10% (No. 160) and 14% (No. 227) of cases, respectively. Distribution by age showed that 25% (No. 419) of patients were less than 5 years old. Exposures to Disinfectants (Main Group (MG) 1, Product type (PT) 1-4) accounted for 49% of cases (No. 810, including 703 cases of low severity poisoning and 108 cases of moderate severity); exposures to Preservatives (MG 2, PT 8 and PT10) accounted for 5% of cases of poisonings (No. 84, including 81 cases of low severity poisoning and 3 cases of

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moderate severity); exposures to Pest Control (Main Group 3, PT 14, PT 16, PT 18-19) accounted for 46% of cases of poisoning (No. 774, including 701 cases of low severity poisoning, 178 cases of moderate severity, and six cases of severe poisoning). In the Table below the distributions of human cases of unintentional exposure to biocides and poisoning by MG and PT of commercial products, chemical class and standard denomination of active ingredients and severity of poisoning are shown.

Table. HUMAN CASES OF UNINTENTIONAL TOXIC EXPOSURE TO BIOCIDES IDENTIFIED IN ITALY IN 2007-2009

MAIN GROUP (MG) Cases of unintentional human exposuresProduct Type (PT) Severity of poisonings*

Chemical class None Low Moderate/ Total

Active compound Severe

No. No. No. No.

MG 1 - DISINFECTANTS

PT 1 - Human hygiene

After biteAmmonium compounds

Ammonium hydroxide 26 4 1 31Biological, Botanical products

Camphor 0 1 0 1Eucalyptus globulus, ext. 0 1 0 1Unknown 23 3 0 26

PT 1 TOTAL 49 9 1 59

% 83.0 15.2 1.7 100.0             PT 2 - Disinfectants, Algaecides

Active oxigen generating agents

Sodium perborate 2 1 0 3

Alcohols

Ethanol 37 12 0 49Alcohols and Quaternary ammonium compounds

Propan-1-ol and Benzalkonium chloride 55 19 2 76

   Propan-1-ol and Didecyldimethyl ammonium

chloride 3 1 0 4

Aldehydes

Formaldehyde 1 6 0 7Glutaraldehyde# 5 8 2 15

Biguanides

Chlorhexidine digluconate 0 ^2 0 2

MG 1 - DISINFECTANTSPT 2 - Disinfectants, Algaecides (continued)

Biguanides and other chemical classes

Chlorhexidine digluconate and Sodium hypochlorite 0 1 0 1

Chlorhexidine digluconate and propan-1-ol 0 0 1 1

Carbonates     Disodium carbonate 43 14 0 57

Carboxilyc acids

Peracetic acid 5 5 ^1 11

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MAIN GROUP (MG) Cases of unintentional human exposuresProduct Type (PT) Severity of poisonings*

Chemical class None Low Moderate/ Total

Active compound Severe

No. No. No. No.Carboxilyc acids and peroxides

Peracetic acid and Hydrogen peroxide 3 7 2 12Chlorine and chlorine inorganic compounds

Chlorine#### 79 145 27 251Calcium hypochlorite 0 2 0 2Sodium hypochlorite 530 141 ^^^17 688

Chlorophenols

    Clorophene 2 3 1 6Unknown 2 0 1 3

Glycols

Triethylen glycol 4 °1 0 5Methylphenols

Cresol 0 1 0 1Peroxides

Hydrogen peroxide 167 64 5 236Quaternary ammonium compounds

Benzalkonium chloride 294 117 20 431Didecyldimethyl ammonium chloride 0 3 0 3Unknown 2 4 0 6

Quaternary ammonium compounds and other chemical classes

Benzalkonium chloride, Copper sulphate,

and Sulfuric acid 1 0 2 3Benzalkonium chloride and Sodium hypochlorite 0 2 0 2Benzalkonium chloride and other compounds 6 3 2 11

Reaction products

Reaction products of: glutamic acid and

N-(C12-14-alkyl)propylenediamine 0 3 2 5Thiazoles and triazines

2-octyl-2H-isothiazol-3-one and

2,2',2''-(hexahydro-1,3,5-triazine-1,3,5-triyl)triethanol 0 1 0 1

Triazines

Sodium dichloroisocyanurate 5 5 2 12Triazines and other chemical classes

Sodium dichloroisocyanurate and boric acid 3 0 1 4Unknown 26 14 2 42

PT 2 TOTAL 1,275 585 90 1,950

% 65.4 29.8 3.7 100.0             

MG 1 - DISINFECTANTS PT 3 - Veterianary hygiene

AldehydesFormaldehyde 0 1 0 1

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MAIN GROUP (MG) Cases of unintentional human exposuresProduct Type (PT) Severity of poisonings*

Chemical class None Low Moderate/ Total

Active compound Severe

No. No. No. No.  Chlorophenols            Clorophene# 23 42 8 73  Chlorophenols and Biphenyls            Clorophene and Biphenyl 2-ol (creoline)# 0 10 0 10

Chlorophenols and Pyrethrins/pyrethroids

Clorophene and Pyrethrins (Pyrethrum) 2 1 0 3

ConazolesImazalil 2 1 0 3

Carboxylic acids and other chemical classes

Acetic acid and Amines, N-coco

alkyltrimethylenedi-, acetates 0 1 0 1Quaternary ammonium compounds

Benzalkonium chloride 4 3 0 7

PT 3 TOTAL 31 59 8 98

% 31.6 60.2 8.2 100.0             PT 4- Food and Feed areas

Carboxylic acids and other chemical classes

Acetic acid, Peracetic acids, and Hydrogen peroxide 0 1 0 1

Formic acid and Propionic acid 0 0 1 1Chlorine and chlorine inorganic compounds

Sodium hypochlorite 3 4 0 7Sodium hypochlorite and Sodium chlorite 13 3 0 16

Chlorine and chlorine inorganic compounds and

other chemical classes

Sodium hypochlorite and Potassium hydroxide 0 2 0 2Hydroxides

Sodium hydroxide 0 2 0 2Quaternary ammonium compounds

Benzalkonium chloride 92 29 3 124Didecyldimethyl ammonium chloride 7 °4 3 14Unknown 0 1 0 1

Quaternary ammonium compounds and other chemical classes

Benzalkonium chloride and

5-chloro-2-(4-chlorophenoxy)phenol (diclosan) 1 0 1 2Benzalkonium chloride and biphenyl-2-ol 1 0 1 2

Triazines

Sodium dichloroisocyanurate 3 3 0 6

PT 4 TOTAL 120 49 9 178

% 67.4 27.5 5.0 100.0

ALL CASES OF EXPOSURE TO DISINFECTANTS 1,475 702 108 2,285% 67.4 30.7 4.2 100.0

             

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MAIN GROUP (MG) Cases of unintentional human exposuresProduct Type (PT) Severity of poisonings*

Chemical class None Low Moderate/ Total

Active compound Severe

No. No. No. No.MG 2 - PRESERVATIVES

PT 8 - Wood preservativesAlkanes and other chemical classes

Propane, Butane, and Naphtha 6 2 0 8

PT 8 - Wood preservatives (continued)Cicloeptani

Endosulfan 2 1 0 3Pyrethrins/Pyrethroids

Cyfluthrin 2 2 0 4Permethrin 45 25 2 72

Unknown 0 1 0 1Pyrethrins/Pyrethroids and other chemical classes

Permethrin and Dichlofluanid 3 2 0 5

Permethrin and Tolyfluanid 0 2 0 2

Unknown 44 29 0 73

PT 8 TOTAL 102 64 2 168

% 60.7 38.1 1.2 100.0

PT 10 - Construction material preservativesQuaternary ammonium compounds

Benzalkonium chloride 1 2 1 4

Unknown 12 15 0 27

PT 10 TOTAL 13 17 1 26

% 50.0 65.4 3.8 100.0ALL CASES OF EXPOSURE TO

PRESERVATIVES 115 81 3 199

% 57.8 40.7 1.5 100.0MG 3 - PEST CONTROL

PT 14 - Rodenticides

CoumarinesBrodifacoum 58 0 ^1 59

Bromadiolone 94 4 2 100Bromadiolone and Difenacoum 2 1 0 3

Coumatetralyl 23 1 0 24Difenacoum 47 2 ^1 50Difethialone 17 1 0 18

IndandionesChlorophacinone 33 1 0 34

Unknown 180 8 1 189

PT 14 TOTAL 454 18 5 577

% 78.7 3.2 0.9 100.0             PT 16 - Molluscides, vermicides, others

AldehydesMetaldehyde 7 1 1 9

PT 16 TOTAL 7 1 1 9

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MAIN GROUP (MG) Cases of unintentional human exposuresProduct Type (PT) Severity of poisonings*

Chemical class None Low Moderate/ Total

Active compound Severe

No. No. No. No.

% 77.8 11.1 1.1 100.0             

MG 3 - PEST CONTROLPT 18 - Insecticides, acaricides, other invertebrates

Private households/professional uses

Carbamates

Bendiocarb 4 1 0 5

Carbaryl 1 3 0 4

Methomyl 44 4 2 50Propoxur 154 22 5 181

Carbamates and Pyrethrins/Pyrethroids

Bendiocarb and Tetramethrin 3 3 0 6Carbaryl and Tetramethrin 4 1 0 5Propoxur and Cyfluthryn 40 °°°22 1 63Propoxur and Tetramethrin 0 0 2 2Propoxur, S-Bioallethrin, and Bioresmethrin 0 1 0 1

Organophosphates

Azamethiphos 2 2 0 4Chlopyrifos# 13 51 3 67

Diazinon 13 4 0 17

Dichlorvos 3 5 ^2 10

Phoxim 7 2 0 9

Temephos 1 0 1 2Organophosphates and Pyrethrins/Pyrethroids

Chlopyrifos and Tetramethrin# 2 46 0 48

Chlopyrifos and Cypermethrin 13 5 ^2 20

Chlopyrifos and Permethrin 0 0 1 1

Diazinon, Cypermethrin, and Tetramethrin 0 2 0 2

Malathion and Tetramethrin 1 0 1 2

Phenylpyrazoles

Fipronil 17 1 0 18

Phenylurea compoundsDiflubenzuron 10 1 0 11

Pyrethrins/Pyrethroids

Alpha-cypermethrin 3 1 0 4Allethrin 82 5 0 87Allethrin and Phenothrin 4 3 1 8Allethrin and other pyrethrins/pyrethroids 13 1 0 14Bifenthrin 8 1 0 9Bioallethrin 98 2 1 101Bioallethrin and Bioresmethrin 5 2 0 7Bioallethrin and Cypermethrin 4 3 0 7Cyphenothrin 1 3 0 4

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MAIN GROUP (MG) Cases of unintentional human exposuresProduct Type (PT) Severity of poisonings*

Chemical class None Low Moderate/ Total

Active compound Severe

No. No. No. No.Cyphenothrin and Imiprothrin# 17 0 1 18

Cyfluthryn 33 7 0 40

Cyfluthryn and Transfluthrin 14 8 1 23

Cypermethrin### 38 42 0 80

Cypermethrin and Imiprothrin 6 5 1 12

Cypermethrin and Permethrin 2 4 0 6

Cypermethrin, Permethrin, and Tetramethrin 6 °4 0 10

Cypermethrin and Tetramethrin# 68 56 5 129

Cyphenothrin and Imiprothrin 17 1 0 18

Deltamethrin## 28 28 1 57

Deltamethrin and Tetramethrin 6 4 1 11

Phenothrin 10 2 0 12

Phenothrin and Permethrin 2 1 0 3MG 3 - PEST CONTROLPT 18 - Insecticides, acaricides, other invertebrates

Private households/professional uses

Pyrethrins/Pyrethroids (continued)

Phenothrin, Permethrin, and Tetramethrin 2 1 0 3

Phenothrin and Tetramethrin# 8 3 7 18

Lambda-cyhalothrin 5 °°4 0 9

Permethrin 47 16 3 66

Permethrin and Pyrethrins (Pyrethrum)# 16 6 0 22

Permethrin and Prallethrin 0 1 0 1

Permethrin and Tetramethrin# 45 °°45 ^2 92

Pyrethrins (Pyrethrum) 23 8 1 32

Pyrethrins (Pyrethrum) and Tetramethrin 3 1 0 4

Prallethrin 62 8 0 70

Prallethrin and Tetramethrin 0 °1 0 1

Tetramethrin 11 7 ^^5 23

Transfluthrin 71 4 0 75

Pyrethrins/Pyrethroids unknown 77 5 0 82

Pyridylmethylamine compounds

Imidacloprid 22 2 0 24Produced by fermentation compounds

Abamectine 32 1 0 33

Unknown 350 40 12 402

Human usePyrethrins/Pyrethroids

Bioalletrina* 3 1 0 4

Phenothrin 7 2 1 10

Phenothrin and Tetramethrin 10 1 0 11

Organophosphates

Malathion 6 1 0 7

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MAIN GROUP (MG) Cases of unintentional human exposuresProduct Type (PT) Severity of poisonings*

Chemical class None Low Moderate/ Total

Active compound Severe

No. No. No. No.

Carbamates

Unknown 4 1 0 5

Unknown 15 2 0 17

Veterinary useAmidines

Amitraz 3 2 0 5

OrganophosphatesTrichlorfon 17 2 1 20

Phenylpyrazoles

Fipronil 7 3 0 10

Phenylpyrazoles and Growth regulators

Fipronil and methoprene 23 3 0 26

Pyrethrins/Pyrethroids Bioallethrin 0 1 0 1

Flumethrin 10 3 0 13

Permethrin 13 1 0 14

Unknown 7 1 0 8Pyrethrins/Pyrethroids and Pyridylmethylamine compounds

Permethrin and Imidacloprid 0 3 1 4

PT 18 TOTAL 1,696 539 65 2,300

% 73.7 23.4 2.8 100.0             

MG 3 - PEST CONTROLPT 19 - Repellents, attractants

Human use

Aromatic aminesN,N-diethyl-m-toluamide* 282 °°°°°66 0 348

Biological, Botanical products

Citronella oil 49 10 0 59

Citronella oil and Eucalyptus Oil 58 2 0 60

Citronella oil and Geranium oil 33 2 0 35Citronella oil, Geranium oil, and other botanical products 12 3 0 15

Citronellal and Lavender oil 12 2 0 14

Citronella oil and other botanical products 36 5 0 41

Geranium oil 4 1 0 5

Other botanical products 6 2 0 8

Unknown botanical products 16 4 0 20

PiperidinesIcaridine 97 °14 0 111

Other classes/unclassified

Ethyl N-acetyl-N-butyl-.beta.-alaninate 1 1 0 2

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MAIN GROUP (MG) Cases of unintentional human exposuresProduct Type (PT) Severity of poisonings*

Chemical class None Low Moderate/ Total

Active compound Severe

No. No. No. No.Benzyl benzoate 13 4 0 17

Environmental useBiological, Botanical products

Camphor 79 13 ^1 93Citronella oil 8 °1 0 9

Chlorobenzenes  1,4-dichlorobenzene 19 2 0 21

Naphthalenes  

Naphthalene 70 12 1 83

Unknown 15 1 0 16

PT 19 TOTAL 810 145 2 957

% 84.6 15.2 0.2 100.0ALL CASES OF EXPOSURE TO PEST CONTROL 2,952 701 73 3,725

% 79,2 18,8 2,0 100,0ALL CASES EXPOSED TO BIOCIDES 4,542 1,484 184 6,210

% 73.1 23.8 3.0 100.0 * Severity of poisonings assessed according to the Poisoning Severity Score (Persson HE et al. J Toxicol 1998; 36(3): 205-13). ^ Including one case of severe poisoning; ^^Including two cases of severe poisoning;^^^Including three cases of severe poisoning. ° including one case of suspected adverse reaction (AR); °° Including two cases of suspected AR; °°° Including three cases of suspected AR; °°°°° Including five cases of suspected AR.# One incident involving four or more cases of poisoning: Glutaraldehyde, 7 cases of low severity poisoning were exposed within a local health clinic; Clorophene, 5 cases of low severity poisoning, outdoor exposure;Creoline, 10 cases of low severity poisoning were exposed at school; Chlorpyriphos, 50 cases of low severity poisoning were exposed within a local health clinic; Chlorpyriphos and Tetrametrin, 45 cases of low severity poisoning were exposed in a hospital; Cyphenothrin and Imiprothrin, 7 cases of low severity poisoning were exposed at home; Pyrethrum, 4 cases of low severity poisoning were exposed at home; Cypermethrin and Tetramethrin, 7 cases of low severity poisoning, outdoor exposure; Permethrin and Tetramethrin, 5 cases of low severity poisoning, occupational exposure.## Two incidents involving four or more cases of poisoning: Deltamethrin, 5 cases of low severity poisoning, occupational exposure; 8 cases of low severity poisoning, outdoor exposure. ### Three incidents involving four or more cases of poisoning: Cypermethrin, 5 cases of low severity poisoning were exposed at school; 8 cases of low severity poisoning were exposed in a camping; 4 cases of low severity poisoning exposed at home. #### Four incidents involving four or more cases of poisoning: Chlorine, four incidents occurred in indoor swimming pools involving 30, 10, 6, 4 cases of low severity poisoning, respectively.

Latvia

The following poisoning cases have been registered:

Year Number of poisoning Product type

2009 1 14

2010 No information -

2011 No information -

2012 6 14

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1 2

1 18

Lithuania

During the period from 2009 to 2012 161 cases of poisonings with biocidal products were registered. Most of the cases were registered in 2011 (48 cases), while the least of poisonings investigated happened in 2012. More than half of the cases includes children poisonings (56.5%).

Children (0 – 17 years old) and adult poisonings with biocidal products from 2009 to 2012 illustrated in Figure 1.

Figure 1. Poisonings with biocidal products between children and adults from 2009 to 2012.

Most of the poisoning cases among children registered in 2009, while among adults – in 2010.

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Half of all poisonings with biocidal products consists of poisonings with rodenticides (48.4%), one-third – of insecticides*. The table shows poisoning cases by the most common product types.

Table. Breakdown between product types.

Product type Cases, %

PT 2 16,1

PT 8 1,8

PT 14 48,4

PT 18 30,4

* in 5 cases unknown product type

Most of the poisoning cases with rodenticides registered in 2009 (25 cases), while most of the poisonings with insecticides – in 2011 (21 cases). Poisonings with biocidal products by product types from 2009 to 2012 as illustrated in Figure 3.

PT 14; 21,7 %

PT 14; 26,7 %

PT 18; 16,7 %

PT 18; 13,6 %

0

5

10

15

20

25

30

Children Adults

Figure 2. Poisonings with biocidal products by product types, children and adults

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PT 2 (9)

PT 2 (11)

PT 2 (6)

PT 8 (2)

PT 8 (1)

2009

2010

PT 14 (25)

PT 14 (21)

PT 14 (20)

PT 14 (12)

PT 18 (8)

PT 18 (8)

PT 18 (21)

PT 18 (12 cases)

0 5 10 15 20 25 30

2012

2011

Figure 3. Poisonings with biocidal products by product types from 2009 to 2012.

Luxembourg

During 2009-2012, no poisonings related to biocides were reported directly to the Ministry of Health. A single case report in 2010 was related to a product, placed on the market as a fertilizer (powder; slaked lime), which was allegedly also used for disinfection purposes. An accidental projection of the product into the eyes of the operator resulted in severe ocular lesions in absence of protective glasses.

CAUSE DEATHS (number of cases)

HOSPITALISATIONS (number of cases)

(ICD-10 Code) 2009 2010 2011 2012 2009 2010 2011 2012T 60.0

0 0 0 0 0 0 0 0Organophosphates + carbamate insecticidesT 60.1

0 0 0 0 0 0 0 0Halogenated insecticidesT 60.2 0 0 0 0 0 0 0 0Other insecticidesT 60.3

0 0 0 0 0 0 0 0Herbicides + fungicidesT 60.4 0 0 0 0 0 0 0 0RodenticidesT 60.8 0 0 0 0 0 0 0 0

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Other pesticidesT 60.9 1case

* (male, age 30-40)

0 0 0 0 0 0 0Pesticides, unspecified

T 65.10 0 0 0 0 0 0 0Strychnine + its

saltsX 68

0 0 0 0

1 case

(male, age 30-39)

0 0

1 case

(male, age 90-99)

Intentional self-poisoning by and exposure to pesticides

X 48

0 0 0 0 0 0 0 0Accidental poisoning by and exposure to pesticidesY18

0 0 0 0

1case (female, age 10-19)

0

2 cases(male, age 10-19)

0

Poisoning by and exposure to pesticides, undetermined intent* Additional descriptors: X69.9 (autointoxication) + T54.9(Corrosive substance, unspecified)

Malta

During 2009-2012 there were 3 reported poisonings involving biocidal products. Following were the type of products involved:

1. Dettol

2. Rat poison

Netherlands

The number of exposures reported to the Dutch National Poisons Information Centre (by telephone):

2010 2011 2012

Biocides Humans Animals Humans Animals Humans Animals

Organophosphates 84 38 52 33 77 57

Carbamates 9 21 8 28 8 12

Chlorinated hydrocarbons 25 9 20 1 19 0

Pyrethrines 122 135 121 146 116 119

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Other insecticides 61 72 93 119 139 129

Combinations of insecticides 15 8 15 26 9 62

Rodenticides 209 235 187 245 205 299

Anti snail agents 23 62 21 63 17 60

Wood preservatives 15 1 10 1 4 1

Repellents 88 4 83 7 96 5

Acaricides 11 10 9 32 5 11

Desinfectants 203 27 187 24 296 26

Other pesticides and combinations 51 36 51 23 54 40

Biocides containing products

Chlorine containing products 539 36 597 44 709 28

Alcohols, phenols and glycols 208 3 274 6 204 3

Aldehydes and ketones 67 2 106 6 91 1

Carboxylic acids and derivatives 31 3 35 0 24 0

Washing-up liquids with ethanol 19 1 10 0 4 0

Explanation on the reported exposures:

The National Poisons Information Centre of the Netherlands records enquiries about (suspected) poisonings, including those due to exposure to biocidal products. The total annual number of enquiries is over 45.000. The Centre does not take calls from the public, so all enquiries mentioned above are from medical professionals. Both human and animal poisonings are handled. Many of the animal poisonings involve poisonings of pet animals, mainly dogs. A majority of the human exposures occur in young children who ingest minor quantities of these products (insecticide containing repellents, rodenticides), rarely causing actual poisonings. The above mentioned exposures to “biocides containing products” often occurred in adults

Poland

In the years 2010-2012 there have been 971 cases of poisonings with biocidal products within the framework of the poison control system of biocidal products in Poland.

Biocidal products posing the greatest threat.

PT 14 187 cases of poisoning

PT 18 165 cases of poisoning

PT 2 152 cases of poisoning

Specification of the poisonings with biocidal products in each PT group and active substances.

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PT Group /the active substance sum % all poisoning

PT 1 1  0,1%

triclosan, CAS: 3380-34-5 1 0,1%

PT 2 152 15,7%

podchloryn sodu/Chloran(I) sodu, CAS: 7681-52-9, WE: 231-668-3 44 4,5%

nadtlenek wodoru, CAS: 7722-84-1 14 1,4%

dihydrat dichloroizocyjanuranu sodu, CAS: 51580-86-0 21 2,2%

kwas glikolowy, CAS: 79-14-1 7 0,7%

kwas amidosulfonowy, CAS: 659-40-5 2 0,2%

dichloroizocyjanuran sodu, CAS: 2893-78-9 13 1,3%

wodorotlenek sodu, CAS: 1310-73-2 11 1,1%

kwas solny (inna nazwa: chlorowodór) CAS: 7647-01-0, WE: 231-595-7 6 0,6%

kwas nadoctowy, CAS: 79-21-0, WE: 201-186-8 Nadtlenek wodoru, CAS: 7722-84-1, WE: 231-765-0 1 0,1%

nadtlenek wodoru, CAS: 7722-84-1, WE: 231-765-0 Czwartorzędowe związki amonowe, benzylo-C12-16-alkilodimetylowe, chlorki, CAS: 68424-85-1, WE: 270-325-2

1 0,1%

kwas cytrynowy jednowodny CAS: 5949-29-1, WE: 201-069-1 (odpowiednik kwasu cytrynowego CAS: 77-92-9; WE: 201-069-1) kwas mrówkowy CAS: 64-18-6, WE: 200-579-1

1 0,1%

chlorek didecylodimetyloamonu, CAS: 7173-51-5, WE: 230-525-2

nadtlenek wodoru, CAS: 7722-84-1, WE: 231-765-0 czwartorzędowe związki amonowe, benzylo-C12-16-alkilodimetylowe, chlorki, CAS: 68424-85-1, WE: 270-325-2

1 0,1%

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kwas nadoctowy, CAS: 79-21-0, WE: 201-186-8 [zaw. 3,07 g/100g]; substancja generowana in situ z prekursorów:

1. nadwęglan sodu, CAS: 15630-89-4, WE: 239-707-6

2. tetraacetylenodiamina, CAS: 10543-57-4, WE: 234-123-8

15 1,5%

kwas cytrynowy, CAS: 77-92-9 2 0,2%

ortobenzyloparachlorofenol CAS: 120-32-1 12 1,2%

czwartorzędowe związki amoniowe, benzylo-C12-18-alkildimetylowe, chlorki, CAS: 68391-01-5 1 0,1%

PT 2, 3 1 0,1%

zieleń malachitowa, CAS: 2437-29-8 1 0,1%

PT 2, 4 9 0,9%

kwas mlekowy, CAS: 50-21-5 2 0,2%

czwartorzędowe związki amonowe, benzylo-C12-16-alkilodimetylowe, chlorki, CAS: 68424-85-1 1 0,1%

Podchloryn sodu/Chloran(I) sodu, CAS: 7681-52-9, 4 0,4%

ditlenek chloru, CAS: 10049-04-4 1 0,1%

kwas glikolowy, CAS: 79-14-1 1 0,1%

PT 2, 9, 10 1 0,1%

chlorek benzalkoniowy (Preventol R80), CAS: 61789-71-7 1 0,1%

PT 3 2 0,2%

podchloryn sodu/Chloran(I) sodu, CAS: 7681-52-9 1 0,1%

bis(peroksymonosiarczano)bis(siarczan) pentapotasu, CAS: 70693-62-8 1 0,1%

PT 3, 4 ,5 1 0,1%

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kwas nadoctowy, CAS: 79-21-0, WE: 201-186-8nadtlenek wodoru, CAS: 7722-84-1, WE: 231-765-0 prekursor kwas octowy, CAS: 64-19-7, WE: 200-580-7

1 0,1%

PT 4 18 1,9%

podchloryn sodowy CAS: 7681-52-9 8 0,8%

kwas mlekowy, CAS: 50-21-5 2 0,2%

wodorotlenek potasowy, CAS: 1310-58-3 podchloryn sodowy, CAS: 7681-52-9 1 0,1%

Parmetol SL 60 mieszanina zawierająca: glutaral, CAS: 111-30-8 oraz mieszaninę 5-chloro-2-metylo-2H-izotiazol-3-onu i 2-metylo-2H-izotiazol-3-onu, CAS: 55965-84-9

1 0,1%

nadtlenek wodoru CAS: 7722-84-1 1 0,1%

chlorek laurylodwumetylobenzyloamoniowy, CAS: 68391-01-5 1 0,1%

izopropanol, CAS: 67-63-0 chlorki czwartorzędowych soli amoniowych benzylo-C-12-14-alkilodimetylowe, CAS:85409-22-9

1 0,1%

kwas nadoctowy, CAS: 79-21-0 3 0,3%

PT 6 1 0,1%

1,2-benzizotiazol-3(2H)-on , CAS: 2634-33-5, WE: 220-120-9;

2-metylo-2H-izotiazol-3-on, CAS: 2682-20-41 0,1%

PT 8 6 0,6%

czwartorzędowe związki amoniowe, benzylo-C12-16-alkolodimetylo, chlorki CAS 68424-85-1

kwas borowy, CAS: 10043-35-3

4 0,4%

tlenek miedzi, CAS: 1317-38-0 kwas borowy, CAS: 10043-35-3 1 0,1%

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węglan miedzi(II)-wodorotlenek miedzi(II0 (1:1) (inna nazwa: zasadowy weglan miedzi(II)), CAS: 12069-69-1, WE: 235-113-6

kwas borowy (inna nazwa: kwas ortoborowy), CAS: 10043-35-3, WE: 233-139-2

tebukonazol, CAS: 107534-96-3, WE: 403-640-2

1 0,1%

PT 8, 10 5 0,5%

chlorek benzalkoniowy (inna nazwa: Preventol R 80), CAS: 8001-54-5 5 0,5%

PT 10 1 0,1%

czwartorzędowe związki amoniowe, benzylo-C12-18-alkildimetylowe, chlorki, CAS: 68391-01-5 1 0,1%

PT 14 187 19,3%

bromadiolon (3-[3-(4′-bromo[1,1′-bifenylo]-4-yl)-3-hydroksy-1-fenylopropylo]-4-hydroksy-2-benzopiron), CAS: 28772-56-7 96 10%

3-[3-(4′-bromobifenyl-4-ilo)-1,2,3,4-tetrahydro-1-naftylo]-4-hydroksykumaryna/Brodifakum, CAS: 56073-10-0 62 6%

sól sodowa warfaryny, CAS: 129-06-6 16 2%

difenakum (3-[3-(bifenyl-4-ylo)-1,2,3,4-tetrahydro-1-naftylo]-4-hydroksykumaryna), CAS: 56073-07-5 6 1%

warfaryna, CAS: 81-81-2 4 0%

difetialon, CAS: 104653-34-1 3 0%

PT 16 10 1,0%

metaldehyd (inna nazwa: 2,4,6,8-tetrametylo-1,3,5,7-tetroksokan), CAS: 9002-91-9 10 1,0%

PT 18 165 17,0%

tiametoksam, CAS: 153719-23-4, WE: 428-650-4 2 0,2%

alfa-cypermetryna, CAS: 67375-30-8, 1 0,1%

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2,2-dimetylo-3-(2-metyloprop-1-enylo)cyklopropanokarboksylan 2-metylo-4-okso-3-(prop-2-ynylo)cyklopent-2-en-1-ylu/Praletryna, CAS: 23031-36-9

1 0,1%

cypermetryna, CAS: 52315-07-8; 1 0,1%

permetryna (inna nazwa: 3-fenoksibenzil-3-(2,2-diklorovinil)-2-dimetilciklopropankarbamat, cis:trans = 25:75), CAS: 52645-53-1 1 0,1%

cypermetryna, CAS: 52315-07-8;

esbiotryna; CAS: - , Środek ochrony roślin1 0,1%

fosforan O-(2,2-dichlorowinylo)-O,O-dimetylu (inna nazwa: dichlorfos), CAS: 62-73-7;

tetrametryna CAS: 7696-12-0;

cypermetryna CAS: 52315-07-8

2 0,2%

dichlorfos/dichlorowinyl, CAS: 62-73-7, WE: 200-547-7 8 0,8%

fosforan O-(2,2-dichlorowinylo)-O,O-dimetylu (inna nazwa: dichlorfos), CAS: 62-73-7;

cypermetryna CAS: 52315-07-8

1 0,1%

diazynon (inna nazwa: tiofosforan O,O-dietylu-O-2-izopropylo-6-metylopirymidyn-4-ylu), CAS: 333-41-5 1 0,1%

N-((6-chloro-3-pirydynylo)metylo)-N′-cyjano-N-metyloetanoimidamid/Acetamipryd, CAS: 160430-64-8, WE: Środek ochrony roślin 1-(6-chloropirydyn-3-ylometylo)-N-nitroimidazolidyn-2-ylidenoamina/Imidaklopryd, CAS: 138261-41-3, WE: 428-040-8

3 0,3%

imidacloprid CAS 138261-41-3;

metomyl, CAS: 16752-77-5 1 0,1%

trans-2-(2,2-dichlorowinylo)-3,3-dimetylocyklopropanokarboksylan 2,3,5,6-tetrafluorobenzylu/Transflutryna, CAS: 118712-89-3

1 0,1%

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eter 2-(2-butoksyetoksy)etylo-6-propylpiperony-lowy/butotlenek piperonylu, CAS: 51-03-6

[1R-[l.alfa.(S*),3.alfa.]]-3-(2,2-dibromowinylo)-2,2-dimetylocyklopropanokarboksylan.alfa.-cyjano-3-fenoksybenzylu/Deltametryna, CAS: 52918-63-5;

Tetrametryna, CAS: 7696-12-0

2 0,2%

eter 2-(2-butoksyetoksy)etylo-6-propylpiperonylowy/butotlenek piperonylu, CAS: 51-03-6 2,2-dimetylo-3-(2-metyloprop-1-enylo)cyklopropanokarboksylan 2-metylo-4-okso-3-(prop-2-ynylo)cyklopent-2-en-1-ylu/ Praletryna, CAS: 23031-36-9 (lR)-cis,trans-2,2-dimetylo-3-(2-metyloprop-1-enylo)cyklo-propanokarboksylan 3-fenoksybenzylu/d-Fenotrin, CAS: 188023-86-1

9 0,9%

fipronil, CAS: 120068-37-3, WE: 424-610-5 20 2,1%

3-(2,2-dichlorowinylo)-2,2-dimetylocyklopropanokarboksylan m-fenoksybenzyl/permetryna, CAS: 52645-53-1, WE: 258-067-9 60 6,2%

dichlorfos (inna nazwa: fosforan 2,2-dichlorowinylu-dimetylu), CAS: 62-73-7;

tetrametryna (inna nazwa: (1-cyclohexene-1,2-dicarboximido)methyl-2,2-dimethyl-3-(2-methylpropenyl)-cyclopropanecarboxylate), CAS 7696-12-0;

cypermetryna (inna nazwa: 2,2-dimetylo-3-(2'2'-dichlorowinylo)cyklopropanokarboksylonu alfa-cyjano-3-fenoksybenzylowego), CAS: 52315-07-8

1 0,1%

deltametryna, CAS: 52918-63-5 tetrametryna, CAS: 7696-12-0;

butoksylan piperonylu (inna nazwa: PBO), CAS: 51-03-61 0,1%

2,4-dodecadienoic acid, 11-methoxy-3,7,11, trimethyl, 1-methylethyl ester, (E,E) (inna nazwa: metopren), CAS: 40596-69-8

1 0,1%

1-(6-chloropirydyn-3-ylometylo)-N-nitroimidazolidyn-2-ylidenoamina/Imidaklopryd, CAS: 138261-41-3, 6 0,6%

trichlorfon CAS 52-68-6 (inna nazwa: ester dwumetylowy kwasu 1-hydroxy-2,2,2 trójchloro-etyloortofosforowego) 1 0,1%

tetrametryna, CAS: 7696-12-0, WE: 231-711-6 eter 2-(2-butoksyetoksy)etylo-6-propylpiperonylowy/butotlenek piperonylu, CAS: 51-03-6, WE: 200-076-7

1 0,1%

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tetramethrin, CAS: 7696-12-0;

2-dimetyl-3-(methylpropenyl)cyclopropanecarboxylate de 3-phenoxybenzyle/Phenotrine, CAS: 26002-80-2

1 0,1%

[1R-[l.alfa.(S*),3.alfa.]]-3-(2,2-dibromowinylo)-2,2-dimetylocyklopropanokarboksylan.alfa.-cyjano-3-fenoksybenzylu/Deltametryna, CAS: 52918-63-5, WE: 258-256-6

4 0,4%

dichlorowinyl/Dichlorfos, CAS: 62-73-7, WE: 200-547-7tetrametryna, CAS: 7696-12-0, WE: 231-711-6; 3-(2,2-dichlorowinylo)-2,2-dimetylocyklopropanokarboksylan.alfa.-cyjano-3-fenoksybenzylu/Cypermetryna, CAS: 52315-07-8, WE: 257-842-9

10 1,0%

alfametryna (inna nazwa: alfacypermetryna) CAS 67375-30-8;

esbiotryna (inne nazwy: bioalletryna; ester(S)-3-allyl-2-metylo-4-oxocyklopent-2-enyl(1R)-trans chryzantemowy) (środek ochrony roślin, PPP); butoksylan piperonylu (inna nazwa: eter 3,4-metylenodioksy-6-propylobenzylo-n-butylodietyloglikolu) CAS: 51-03-6

6 0,6%

3-(2,2-dichlorowinylo)-2,2-dimetylocyklopropanokarboksylan.alfa.-cyjano-3-fenoksybenzylu/Cypermetryna, CAS: 52315-07-8, WE: 257-842-9;

(1R,3R)-2,2-dimetylo-3-(2-metyloprop-1-enylo)-cyklopropanokarboksylan (RS)-3-allilo-2-metylo-4-oksocyklopent-2-enylu ((mieszanina 2 izomerów 1R trans: 1R/S wyłącznie 1:3)/Esbiotryna, WE: Środek ochrony roślin

1 0,1%

fenitrotion CAS: 122-14-5, WE: 204-524-2 1 0,1%

lambda cyhalotryna (mieszanka alfa-cyjano-3-fenoksybenzylu (Z)-(1R,3R)-[(S)-3-(2-chloro-3,3,3-trifluoro-prop-1-enylo)]-2,2-dimetylocyklopropanokarboksylan; alfa-cyjano-3-fenoksybenzylu (Z)-(1S,3S)-[(R)-3-(2-chloro-3,3,3-trifluoroprop-1-enylo)]-2,2-dimetylocyklopropanokarboksylan), CAS: 91465-08-6

2 0,2%

permetryna CAS: 52645-53-1;

pyriproxyfen CAS: 95737-68-1 4 0,4%

karbaryl (inna nazwa: 1-naftylo N-metylokarbaminian), CAS: 63-25-2 1 0,1%

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trans-2-(2,2-dichlorowinylo)-3,3-dimetylocyklopropanokarboksylan 2,3,5,6-tetrafluorobenzylu /Transflutryna, CAS: 118712-89-3, WE: 405-060-5

3 0,3%

esbiotryna; CAS: - , Środek ochrony roślin 1 0,1%

cypermetryna CAS: 52315-07-8;

imiprotryna CAS: 72963-72-51 0,1%

tetrametryna, CAS: 7696-12-0; permetryna, CAS: 52645-53-1; 1 0,1%

abamektyna, CAS: 71751-41-2 1 0,1%

fipronil, CAS: 120068-37-3 1 0,1%

N-[[(4-chlorofenylo)amino]karbonylo]-2,6-difluorobenzamid, CAS: 35367-38-5 1 0,1%

PT 19 17 1,8%

ftalan di metylu, CAS: 131-11-3 1 0,1%

N,N-dietylo-m-toluamid, CAS: 134-62-3 8 0,8%

N-acetylo-N-butylo-.beta.-alaninian etylu (inna nazwa: etyl butyloacetylaminopropionate, IR3535) CAS: 52304-36-6, WE: 257-835-0

2 0,2%

olejek lawendowy, CAS: 91722-69-9 1 0,1%

(1R,3R)-2,2-dimetylo-3-(2-metyloprop-1-enylo)-cyklopropanokarboksylan (RS)-3-allilo-2-metylo-4-oksocyklopent-2-enylu ((mieszanina 2 izomerów 1R trans: 1R/S wyłącznie 1:3)/Esbiotryna CAS: ---, WE: środek ochrony roślin

1 0,1%

aldehyd cynamonowy, CAS: 104-55-2;

2-undekanon, CAS: 112-12-91 0,1%

naftalen, CAS: 91-20-3 2 0,2%

ethyl butylacetylaminopropionate (inna nazwa: N-acetylo-N-butylo-.beta.-alaninian etylu, nazwa handlowa: Insect Repellent IR3535), CAS: 52304-36-6, WE: 257-835-0

1 0,1%

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PT 23 7 0,7%

chloraloza, CAS: 15879-93-3, WE: 240-016-7 4 0,4%

fosforek glinu, CAS: 20859-73-8, WE: 244-088-0 powstaje in situ podczas spalania świecy z prekursorów: 1) Chloran (V) potasu, CAS: 3811-04-9; WE: 223-289-7 2) Fosforan wapnia trizasadowy, CAS: 7758-87-4, WE: 231-840-8 3) Aluminium proszek, CAS: 7429-90-5, WE: 231-072-3

2 0,2%

brodifacoum, CAS: 56073-10-0;

chloraloza, CAS: 15879-93-31 0,1%

A total of 584

The percentage of cases of poisoning in each PT group, where the identity of the active substance was impossible to identify (387 cases of poisoning).

Product group

PT

% all poisoning

PT 14 19,4%

PT 18 9,7%

PT 2 8,4%

PT 23 0,2%

PT 4 0,1%

PT 8 0,1%

undetermined PT 2,0%

Romania

The cases of poisoning with biocidal products amongst the population, reported at the Centre for Poisoning Information (Office for International Sanitary Regulation and Toxicological Information, NIPH Bucharest) during 2009-2011, are summarized in the table 1.

Table 1

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Exposed Group/ Product types nonprofessional non-

professionalnon-professional

professional

2009 2010 2011 2010 2011

PT01 35 34 47

PT02 122 131 122 2

PT03 10 8 13

PT04 4 14 14

PT05 22 17 20

PT06 1 0 0

PT07 13 19 20

PT08 6 9 4

PT09 10 8 8 1

PT10 13 6 11

PT11 3 7 2

PT12 - - -

PT13 - - -

PT14 29 37 29

PT15 1 0 0

PT16 0 0 1

PT17 1 0 1

PT18 249 244 209

PT19 5 14 6

PT20 8 25 6

PT21 0 1 3

PT22 6 14 11

PT23 1 2 2

Total cases 539 590 529 3

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The Forensic Health Care Institute - Toxicology Laboratory reported for the period 20092012 a total number of 80 deaths, following the ingestion of pesticides products

(agricultural insecticides and herbicides, partially banned as biocides):

No. of cases 2009 2010 2011- sept 2012

Total cases 1 34 25 20

Insecticides: alfamethrin*, diazinon*, dimethoate*, deltamethrin*, endosulfan, furadan, imidacloprid*, malathion*, methomyl*, parathion, sulfotep

Herbicides: 2,4-D, acetochlor, dinoseb,

Fungicides: metalaxyl

* - biocidal active substance simultaneously, some of them banned as biocides, according to European non-inclusion decisions.

Slovakia

Year 2009 2010 2011 2012 2009-2012Number of Total 179 67 65 71 382poisonings Accidental 149 53 53 63 318

Intentional 30 14 12 8 64Way of exposure Oral 82 50 39 44 215

Inhalation 88 16 23 24 151Dermal 5 0 1 1 7Eye 4 1 2 2 9

Distribution of 0. no 120 0 0 0 120poisonings according 1. moderate 52 65 61 70 248severity [2] 2. medium 2 2 3 1 8

3.significant 5 0 1 0 6

2 Persson H., Sjoberg GK., Haines JA., Pronczuk de Garbino J.: Poisoning Severity Score. Grading of Acute Poisoning. Journal of Toxicology and Clinical Toxicology, 36 (3), 205-213, 1998.

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4.death 0 0 0 0 0Cases Reported PTs1-5:According PT Chlorine 41 26 31 45 143

Not specified disinfectants

41 18 15 19 93

PT 14 4 1 5 2 12PT 18 36 22 14 5 77Not specified 57 0 0 0 57

Slovenia

As from 2009 until 2012, the Slovenian Poisoning Control Centre received information on 143 poisonings. 5 of which were considered serious.

Year 2009: 27 reported poisonings (16 children under 5 years)

In 13 cases there was no health problem.

Information on the products:

PT No. of poisonings

Substances involved

2 12 sodium hypochlorite

hydrogen peroxide

ethanol didecyldymethyl ammonium chloride

14 7 bromadiolone

18 6 tetramethrin, boric acid bifenthrin carbamates

19 2 no data on a.s.

Year 2010: 29 reported poisonings (13 children under 5 years)

In 10 cases there was no health problem.

Information on the products:

PT No. of poisonings

Substances involved

1 3 propan-1-ol

propan-2-ol

ethanol didecyldymethyl ammonium chloride

2 11 glutaral chlorine propan-2-ol ethanol didecyldymethyl ammonium chloride

quaternary ammonium compound

4 1 corrosive a. s.

sodium dichloro diizocianurate

8 4 IPBC copper (II) oxide

copper (II) hydroxide

boric acid propiconazole

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14 3 bromadio-lone

18 6 tetrameth-rin

bifenthrin permethrin allethrin

Year 2011: 40 reported poisonings (22 children under 5 years)

In 22 cases there was no health problem.

Information on the products:

PT No. of poisonings

Substances involved

1 3 propan-2-ol ethanol benzalconium chloride

2 13 chlorine quaternary ammonium compound

ethanol simclosene sodium hypochlorite

peracetic acid

8 1 copper (II) oxide

copper (II) hydroxide

boric acid

10 1 quaternary ammonium compound

14 13 bromadiolone

18 8 tetrameth-rin

bifenthrin permethrin cypermethrin

phenothrin

19 1 DEET

Year 2012: 47 reported poisonings (18 children under 5 years)

In 28 cases there was no health problem.

Information on the products:

PT No. of poisonings

Substances involved

1 7 propan-1-ol propan-2-ol

ethanol quaternary ammonium compound

2 19 sodium hypochlorite

cooper sulphate

quaternary ammonium compound

ethanol simclosene alkyl benzyl dimethyl ammonium chloride, glucoprotamine

4 1 quaternary ammonium

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compound

8 2 copper (II) oxide

copper (II) hydroxide

boric acid quaternary ammonium compound

14 9 bromadiolone

18 5 permethrin cypermethrin

bifenthrin spinosad

19 4 icaridin

Spain

According to the Toxicological Surveillance System of voluntary declaration of cases of poisoning or accidents with chemical products attended in the Emergency Units of 13 Hospitals, 107 cases of poisoning by pesticides (this figure includes agriculture and non-agriculture pesticides) have been notified; 36.25% of these cases have been domestic poisonings

Product Type/substances involved and cases reported:

Insecticides: 62

Organophosphates: 23

Pyrethroids: 28

Others: 11

Rodenticides: 10

Fungicides: 3

Moreover, the Instituto Nacional de Toxicologia, through their Toxicological Information Service, has made available the data for poisonings attended on the telephone or accidents which involved biocidal products in the period from the 1 st June 2009 to 31st May 2012. In total there were 20,061 calls, of which 15,937 were calls about poisonings in humans and 4,124 in animals.

On a total of 15,937 poisonings in humans, 34,2% of the cases were by insecticides (20,2% related to pyrethroids, 5,7% to cholinesterase inhibitors , 2,3% organochlorides, 0,3% acaricides, 4,8% others); 6,8% were by rodenticides, 40,9% disinfectants, of which 37,5% were related to bleach, hypochlorite and other acids and chlorine releasers and 4% repellents.

Of the 4,124 calls about animal poisonings, 51.6% of the cases were by rodenticides and 39,5% insecticides (17% related to pyrethroids, 9,7% Inhibitors cholinesterase, 1,3%

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organochlorides, 0,8% acaricides, 10,7% others), 6,2% disinfectants (4,9% related to bleach, hypochlorite and other acids and chlorine releasers) and 0,5% repellents

Sweden

The data in the table below from the Swedish Poisons Information Centre accounts for:

The number of questions regarding poisoning of humans and animals (figures within brackets) by biocides received by the Swedish Poisons Information Centre during 2010-2012. The questions in the year 2009 were included in the Article 24 report 2010.

Division of the poisoning cases between types of biocides. However, the division does not match the division into product types under the directive with exceptions for antifouling products, rodenticides and wood preservatives. A more detailed breakdown is not possible due to various factors including:

the limited information usually available regarding the products involved;

the difficulty in knowing whether a product falls under the scope of the directive or to which product type they belong. This is a difficult problem to solve until all products are labelled in accordance with the directive/regulation.

The biocides are also divided into three different classes that are accounted for separately. The classes have the following meanings:

Class 1: Products for professional use only, requiring a special permit.

Class 2: Products for professional use only.

Class 3: Products that may be used by anyone.

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Questions about poisonings involving biocides the years 2010-2012

Product 2010 2011 2012 Comments

antifouling 16 5 11

rodenticides, warfarin 39 (137) 37 (59) 36 (64) Humans (animals)

rodenticides, super warfarin 43 (167) 60 (113) 40 (97) Humans (animals)

rodenticides, unknown 82 (102) 68 (69) 59 (61) Humans (animals)

wood preservatives 23 (2) 17 (3) 14 (0) Humans (animals)

pesticide, class 3, mosquito repellent 112 (6) 74 (4) 97 (5) Humans (animals)

pesticide, class 1-2, org. phosphoric comp. 6 (0) 3 (2) 5 (0) Humans (animals)

pesticide, class 3, org. phosphoric comp. 50 (36) 44 (42) 62 (23) Humans (animals)

pesticide, class 1-2, pyrethroids 26 (12) 18 (7) 32 (2) Humans (animals)

pesticide, class 3, pyrethroids 151 (43) 126 (33) 135 (25) Humans (animals)

pesticide, class 1-2, unspecified 31 (11) 38 (12) 45 (7) Humans (animals); Unknown if biocide or PPP

pesticide, class 3, unspecified 296 (120) 303 (112) 349 (76) Humans (animals); Unknown if biocide or PPP

pesticides unspecified/unknown 63 (23) 66 (10) 60 (13) Humans (animals); Unknown if biocide or PPP

biocide, mothballs 8 6 4

disinfectants, anti algae, quaternary ammonium comp. 13 (0) 12 (1) 27 (0) Humans (animals)

disinfectants, anti algae, unspecified 16 (2) 6 (0) 18 (0) Humans (animals

disinfectants, ethanol/isopropanol 921 (1) 960 (1) 1049 (4) Humans (animals

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Product 2010 2011 2012 Comments

disinfectants, phenol, cresol 12 15 18

disinfectants, formaldehyde 3 8 3

disinfectants, hypochlorite 148 (7) 114 (4) 124 (3) Humans (animals

disinfectants, iodine 16 (3) 20 (0) 19 (2) Humans (animals

disinfectants, potassium permanganate 17 (1) 23 (0) 11 (1) Humans (animals

disinfectants, quaternary ammonium comp. 41 (2) 31 (0) 54 (1) Humans (animals

disinfectants, peroxides 25 (0) 27 (0) 23 (1) Humans (animals

disinfectants, unspecified 124 (3) 143 (2) 122 (1) Humans (animals

pool chemical, hypochlorite 137 (0) 144 (0) 132 (1) Humans (animals

pool chemical, iodine 16 20 19

pool chemical, quaternary ammonium comp. 8 5 6

pool chemical, percarbonates 1 2 1

pool chemical, peroxides 8 5 2

pool chemical, NaOH 0 3 1

pool chemical, alkali others 2 2 2

pool chemical, acid 29 2 5

pool chemical, unspecified 62 (5) 68 (8) 58 (2) Humans (animals

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Product 2010 2011 2012 Comments

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United Kingdom

The NPIS records enquiries about suspected poisoning incidents, which will include those involving biocidal products. From the data available it has not always been possible to differentiate between Biocidal Products, Plant Protection Products and Veterinary Products. Therefore the numbers of incidents that actually involved Biocidal Products may be less than reported. In addition it has not been possible to determine the Product Type involved in the reported incident. Therefore all possible Product Types have been noted.

Previously the UK Biocides CA reported from April 2007 to March 2009 inclusive. These data did not include telephone enquiries to NPIS. For this questionnaire data are available from April 2009 to March 2012 inclusive, and are reported below. Due to changes in the way in which data have been recorded by NPIS, figures below now do include telephone enquiries, and will be greater than in previous years as a consequence.

1. April 2009 to March 2010

During the period between April 2009 and March 2010 there were a total of 905 patient exposures recorded by NPIS. The majority of these were to biocides and plant protection products.

Of these 905 exposures, 84 were due to deliberate self-harm, with Product-Type (PT)14 being most common; the most frequently reported identifiable biocidal active substances are shown in Table 1. A description of the biocidal PTs is annexed to this report.

Table 1 Most frequently reported identifiable biocidal active substances implicated in instances of self-harm April 2009 to March 2010

Active Substance

Product Type

Number of reports

Bromadiolone PT14 13

Difenacoum PT14 5

Permethrin PT8, 9 &18 4

Of the remaining 821 accidental exposures, the vast majority were acute in nature; the most frequently reported identifiable biocidal active substances are shown in Table 2.

Table 2 Most frequently reported identifiable biocidal active substances implicated in instances of accidental exposure April 2009 to March 2010

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Active Substance Product Type Number of reports

Permethrin PT8, 9 &18 87

Tetramethrin PT18 36

Bendiocarb PT18 29

Cypermethrin PT8 & 18 27

Bromadiolone PT14 21

Difenacoum PT14 20

Imidacloprid PT18 17

Alpha-Cypermethrin PT18 11

Boric acid PT8 10

D-Phenothrin PT18 9

Deltamethrin PT18 8

Pyrethrins PT18 & 19 8

Sodium hypochlorite

PT1, 2, 3, 4, 5, 11 & 12

3

2. April 2010 to March 2011

During the period between April 2010 and March 2011 there were a total of 1215 patient exposures recorded by NPIS. The majority of these were to biocides and plant protection products.

Of these 1215 exposures, 127 were due to deliberate self-harm, with PT14 being most common; the most frequently reported identifiable biocidal active substances are shown in Table 3.

Table 3 Most frequently reported identifiable biocidal active substances implicated in instances of self-harm April 2010 to March 2011

Active Substance Product Type Number of

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reports

Bromadiolone PT14 9

Permethrin PT8, 9 &18 6

Aluminium phosphide

PT14, 18 & 23

5

Difenacoum PT14 4

Bendiocarb PT18 3

Cypermethrin PT8 & 18 3

Of the remaining 1088 accidental exposures, the vast majority were acute in nature; the most frequently reported identifiable biocidal active substances are shown in Table 4.

Table 4 Most frequently reported identifiable biocidal active substances implicated in instances of accidental exposure April 2010 to March 2011

Active Substance Product Type Number of reports

Permethrin PT8, 9 &18 93

Bromadiolone PT14 41

Difenacoum PT14 41

Deltamethrin PT18 35

Tetramethrin PT18 33

Bendiocarb PT18 33

Imidacloprid PT18 30

Cypermethrin PT8 & 18 29

Fipronil PT18 18

Pyrethrins PT18 & 19 16

D-Phenothrin PT18 15

Aluminium phosphide

PT14, 18 & 23

10

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Bifenthrin PT8 & 18 7

Alpha-Cypermethrin PT18 7

3. April 2011 to March 2012

During the period between April 2011 and March 2012 there were a total of 1165 patient exposures recorded by NPIS. The majority of these were to biocides and plant protection products.

Of these 1165 exposures, 107 were due to deliberate self-harm, with PT14 being most common; the most frequently reported identifiable biocidal active substances are shown in Table 5.

Table 5 Most frequently reported identifiable biocidal active substances implicated in instances of self-harm April 2011 to March 2012

Active Substance

Product Type

Number of reports

Bromadiolone PT14 14

Difenacoum PT14 8

Tetramethrin PT18 3

Permethrin PT8, 9 &18 2

D-phenothrin PT18 2

Of the remaining 1058 accidental exposures, the vast majority were acute in nature; the most frequently reported identifiable biocidal active substances are shown in Table 6.

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Table 6 Most frequently reported identifiable biocidal active substances implicated in instances of accidental exposure April 2011 to March 2012

Active Substance Product Type Number of reports

Permethrin PT8, 9 &18 84

Tetramethrin PT18 36

Bromadiolone PT14 35

Difenacoum PT14 33

Aluminium phosphide PT14, 18 & 23 25

Bendiocarb PT18 25

Deltamethrin PT18 21

Fipronil PT18 19

D-Phenothrin PT18 15

Imidacloprid PT18 15

Pyrethrins PT18 & 19 14

Cypermethrin PT8 & 18 13

Benzalkonium chloride PT1, 2, 3, 4, 8, 10 &12

12

Propiconazole PT7, 8 & 9 7

Spinosad PT18 7

Lambda cyhalothrin PT18 6

Bifenthrin PT18 5

1,2-benzisothiazolin-3-one

PT2, 6, 9, 11, 12 & 13 5

Calciferol PT14 5

Fatty acids PT4, 18 & 19 4

Norway

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We do not have a complete national statistic on poisonings involving biocidal products in Norway. However, we have some data from the Norwegian Poison Information Centre, who register the number of inquiries concerning poisonings. The number of inquiries does not correspond to the number of patients or give specific information on the number of poisonings. There can be several inquiries involved in one poisoning accident.

Data from the Norwegian Poison Information Center

Type of biocide product

2009 2010 2011 2012

Rodenticides 102 101 93 95

Rodenticides, number of which concerned second generation rodenticides

66 66 60 66

Antifouling products

24 27 31 26

Disinfectants 526 550 591 530

Insecticides 243 195 219 212

Wood preservatives

20 15 18 25

Wood preservatives number of which concerned creosote

11 8 4 8

Switzerland

The following table contains the numbers of phone calls to the Swiss Toxicological Information Centre for poisonings with various types of biocidal products. There is no obligation in Switzerland to report poisonings to the Toxicological Information Centre or to the authorities. From representative polls it is established that less than 20% of the Swiss population knows the Toxicological Information Centre. It can therefore be assumed that the real numbers are much higher.

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Type of biocidal product Year 2009 Year 2010 Year 2011 Year 2012

Rodenticides 8 18 7 10

Fungicides 0 4 2 4

Wood preservatives 1 2 7 6

Preservation products 0 1 1 4

Disinfectants 22 17 28 39

Insecticides 19 26 24 30

Snail baits (molluscicides)

1 1 3 0

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ANNEX II

Contact details Competent Authorities for Biocides

All contact details can be found on the Commissions' CIRCABC website:

https://circabc.europa.eu/w/browse/955f72d0-144e-4d52-a1c8-44a24be96706

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