Regulation On The Duties Of Notification According To § 16E Of The Chemicals Act Of Prevention And Information For Poisoning

Original Language Title: Verordnung über die Mitteilungspflichten nach § 16e des Chemikaliengesetzes zur Vorbeugung und Information bei Vergiftungen

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Read the untranslated law here: http://www.gesetze-im-internet.de/chemgiftinfov/BJNR014240990.html

Regulation on the duties of notification according to § 16e of the chemicals Act of prevention and information for poisoning (poison information Ordinance - ChemGiftInfoV) ChemGiftInfoV Ausfertigung date: 17.07.1990 full quotation: "poison information regulation as amended by the notice of 31 July 1996 (BGBl. I p. 1198), most recently by article 4 of the Decree of 11 July 2006 (BGBl. I p. 1575) is changed" stand: Neugefasst by BEK. v. 31.7.1996 I 1198;
 
as last amended by article 4 V v. 11.7.2006 I 1575 for more details to the stand number you see in the menu see remarks footnote (+++ text detection from: 1.8.1990 +++) article 1 scope this Regulation meets detailed provisions on type, scope, contents and form of notices to the Federal Institute for risk assessment, 1 which brings one, of certain preparations or a biocidal product on the market, to leave after section 16e, paragraph 1 of the chemicals Act has , 2. to give has a doctor after section 16e para 2 of the chemicals Act in cases of poisoning.

§ 2 notification obligation for the placing on the market of preparations and biocidal products (Section 16e para 1 of the chemicals Act) (1) which received notification pursuant to Section 16e, para 1 of the chemicals Act at 1 at initial release prior to the placing on the market, using the form according to annex 1, 2. a modification announcement immediately using the form according to annex 2, stating the notification number assigned by the Federal Institute for risk assessment to be carried out. At least the information on paragraphs 1 to 8 of the form shall be communicated at initial release according to Appendix 1. The Federal Institute for risk assessment confirms the receipt of the communication the Communicator and tells him the release number.
(2) a person who brings a preparation or a biocidal product unchanged or as a component of own preparation under his own trade name in the traffic, can replace 3 of the form number information according to Appendix 1 by a reference to the message including a notification of change of manufacturer or importer of this preparation or this biocidal product, if he indicates name and address of the manufacturer or importer, the trade name of preparation or of the biocidal product and the release number of the Federal Institute for risk assessment.
(3) the Federal Institute for risk assessment can allow the transmission of the information referred to in paragraph 1 and 2 also on another suitable medium.

Medical notification obligation for intoxication (Section 16e para 2 of the chemicals Act) (1) after section 16e para 2 of the chemicals Act notification has to be made using the form according to annex 3 which must include at least information on paragraphs 1 to 4 of the form § 3. She has 1 acute diseases after completion of treatment, 2. chronic diseases according to the diagnosis, 3. at a consultation in connection with disease after completion of counseling, 4. unless an autopsy is carried out in the event of illness resulting in death, to be carried out immediately after its conclusion. If an information and treatment centre for poisoning is consulted for advice, a message only from the attending physician is to perform.
(2) the Federal Institute for risk assessment can allow the transmission of the information referred to in paragraph 1 in other appropriate ways.

§ 4 confidentiality all data submitted on the forms after the appendices 1, 2 and 3, including the voluntary information, are confidential. The information contained in the form according to annex 3 may be processed to produce a person reference to the patient or used.

§ 5 (dropped out) § 6 (entry into force) Annex 1 (to § 2 para 1 sentence 1 No. 1) (reference: BGBl. 2002 I, 2519-2521; regarding the details of the changes see footnote) Please fill in clearly legible.
At the Federal Institute for risk assessment documentation and assessment body for poisoning P.o. box 33 00 13 14191 Berlin release () a preparation () a of a biocidal product (initial release according to § 16e para 1 of the chemicals Act) 1) name of company, address... b) company... telephone number c) competent authority of the company for information about the preparation / the biocidal product...
Tel.-Nr.: .......................................................
Tel. after hours...
2. a) trade name of the preparation / biocidal product... b) cooking / the biocide is product by notifying company - - I I I made I introduced - - - I I by another company involved and unchanged in the - traffic a 3 ingredients) special ingredients to be aa) biocidal active substances (in the case of notices to biocidal products), bb) very toxic, toxic, carcinogenic, mutagenic or sensitising substances from the concentration , with which they contribute, or at least 0.1% for marking a preparation or a biocidal product, cc) strongly corrosive acids and alkalis, nitric acid, hydrochloric acid, sulphuric acid, potassium hydroxide, sodium hydroxide, quaternary ammonium compounds and phenols from 0.1%, as far as these substances do not see aa or bb) fall, dd) corrosive substances at room temperature liquid - halogen hydrocarbons - petroleum distillates including mixtures, specifying the CAS numbers, - glycols, but not polyglycols , 1%, as far as these substances do not see aa), bb) or cc) fall.
The concentration of the substance in the preparation / the biocidal product is to specify precisely (relatively) on 10%. As far as contents of less than 5% to be and not knowing the exact concentration of the substance is necessary for assessing the hazard potential of the preparation, the concentration specified in these concentration levels can be done: to below 0.1%, 0.1% to less than 0.5%, 0.5%, 1.0%, 1.0%, 1.5%, 1.5% to less than 2.0%, 2.0%, 3.0%, 3.0%, 4.0%, 4.0% to below 5.0%. Also different concentration range stated are allowed in production due to normal fluctuations.
-I materials I CAs I concentration or I phrases I I I number I concentration level I I where to sleep-I where to sleep-I-I-I-I where to sleep-I-I-I-I where to sleep-I-I-I-I where-I-I-I-I - b) other ingredients to be all other ingredients for a content from 1.0 to 100 percent by weight.
If not the knowledge of the individual substance is necessary for assessing the hazard potential of the preparation / of the biocidal product, and similar physical/chemical and toxicological properties, a group name can be used instead of the name of the individual substance, E.g.
-cationic surfactants, anionic surfactants, nonionic surfactants, - fatty acids - plant oils.
The concentration of the substance in the preparation / in the biocidal product is to specify precisely (relatively) to 20%. As far as contents of less than 10% are to be specified and not knowing the exact concentration of the substance is necessary for assessing the hazard potential of the preparation / of the biocidal product, the concentration specified in these concentration levels can be done: 1.0%, 2.0%, 2.0%, 4.0%, 4.0% to below 7.0%, 7.0% and less than 10.0%. Also different concentration range stated are allowed in production due to normal fluctuations.
-I materials I CAs I concentration or I R-Sätze I
I I Nummer I Konzentrationsstufe I I
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I-----------------------I--------I---------------------I---------------I
I-----------------------I--------I---------------------I---------------I
I-----------------------I--------I---------------------I---------------I
I-----------------------I--------I---------------------I---------------I
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4. Kennzeichnung der Zubereitung
a) Gefahrensymbole .................................................
b) Gefahrenbezeichnungen ...........................................
c) Hinweise auf besondere Gefahren (R-Sätze) .......................
... d) safety advice (S-phrases)... e) more flags...... f) classification due to the exam preparation / biocidal product... due to calculation procedure...
5. type of use, purpose of use, as well as for biocidal products group and product type according to annex V of to Directive 98/8/EC in their most recent version published in the official journal of the European communities...
6 information on the packaging of a) shapes (such as jar, spray can, bottle with screw cap, dropper, etc.)
... b) quantity (ml or g)... - c) I I the containers carries a child lock --d) I I the containers bear a tactile warning signs - 7 recommendations on precautions for poisoning and emergency measures for accidents.........
8 pH of a mixture/preparation of water in the ratio 1:1, if the value under 2.5 or above 10.0 is... - additional information (optional) 9 analysis of main ingredients (method, matrix)...
10 consistency of preparation / of the biocidal product (such as easily mobile liquid, viscous, powder, paste, etc.)
....................................................................
11 colour preparation / of the biocidal product.
12 dangerous reactions with other preparations/biocidal products that are intended for the consumer...
13. Sonstige Angaben
....................................................................

Annex 2 (to § 2 para 1 sentence 1 No. 2) (site: BGBl. 2002 I, 2522; regarding the individual change cf. footnote) Please fill in clearly legible.
At the Federal Institute for risk assessment documentation and assessment body for poisoning P.o. box 33 00 13 14191 Berlin the notification of change of a preparation / a biocidal product (notification of change to Section 16e, para 1 of the chemicals Act) A. name of company, address...
Trade name of the preparation / biocidal product...
(B). By the Federal Institute for issued risk assessment notice number... - C. I I the preparation / the biocidal product is from the... final - no longer marketed.
-I I the preparation the biocidal product is brought... for the first time - in the following form in the traffic from.
D. identification of the numbers 1 to 13 of form to the initial communication that have changed compared to the last release. Modified concentrations must be only, if is the concentration of substances 3A) by more than 10%, for substances according to 3B) has changed by more than 20% of the declared value (relatively). (A claim one is under 3a) or 3 b) specified concentration levels takes place, a change notification is necessary if this concentration level was abandoned. Is due to production due to normal fluctuations in a concentration range indicated, the notification of a change is necessary, if the specified concentration range was abandoned.
To clearly distinguish the original and the modified preparation / the original and the modified biocidal product E. characteristics, which can be (such as packaging code, color)......

Appendix 3 (to § 3 para 1) (site: Federal Law Gazette 2002 I, 2523; regarding the details of the changes see footnote) Please fill in clearly legible.
-I I I I am the I I Federal Institute for risk assessment I documentation and assessment body I I for poisoning I I P.o. box 33 00 13 I I 14191 Berlin I original stamp, I I phone and I I signature of the doctor I I I - communication poisoning n Oh Section 16e para 2 of the chemicals Act (BgVV: phone: 01888 412 3460, fax: 01888-412-3929, E-Mail: giftdok § bgvv.de) 1 - I age... Jahre ---- männlich ---- weiblich I Schwangerschaft: I
I I I I I I ---- I
I ---- ---- I I I Ja I
I I ---- I
I Monate ..... (for children under 3 years of age) I ---- I
I I I I Nein I
I I ---- I
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I Freiwillig auszufüllen I
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2. -Poisoning - I suspect I I I - - - I necessarily trade name I substance name, intakes and manufacturers (distributors) indicate preparation / of the biocidal product or I; I
I gegebenenfalls vermutete Ursache I
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I I
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I I
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I I
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3. Exposition: ---- ----
I I akut I I chronisch
---- ----
---- ---- ---- ---- ----
I I oral I I inhalativ I I Haut I I Auge(n) I I Sonstiges
---- ---- ---- ---- ---- welche? ...
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I Ätiologie: ---- akzidentell ---- ---- I
I I I (Unfall) I I gewerblich I I Verwechslung I
I ---- ---- ---- I
I I
I ---- suizidale ---- ---- ---- I
I I I Handlung I I Abusus I I Umwelt I I Sonstiges I
I ---- ---- ---- ---- I
I I
I Ort: ---- ---- ---- I
I I I Arbeitsplatz I I im Haus I I Schule I
I ---- ---- ---- I
I I
I ---- ---- ---- I
I I I Kindergarten I I im Freien I I Sonstiges I
I ---- ---- ---- I
I I
I Labor-Nachweis: ---- ---- I
I I I Ja I I Nein I
I ---- ---- I
I I
I Behandlung: ---- ---- ---- I
I I I keine I I ambulant I I stationär I
I ---- ---- ---- I
I I
I Verlauf: ---- ---- ---- ---- I
I I I nicht I I vollständige I I Defektheilung I I Tod I
I ---- bekannt ---- Heilung ---- ---- I
I I
I ---- I
I I I Spätschäden (nicht auszuschließen) I
I ---- I
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I Freiwillig auszufüllen I
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I 4. Symptome/Verlauf (stichwortartig) I
I ggf. anonymisierte Befunde, Epikrise(n) I
I I
I I
I I
I I
I I
I I
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