Regulation on the notification requirements in accordance with § 16e of the Chemicals Act for the Prevention and Information of Poisoning Information (Giftinformationsverordnung-ChemGiftInfoV)

Unofficial table of contents

ChemGiftInfoV

Date of completion: 17.07.1990

Full quote:

" Poison Information Regulation, as amended by the Notice of 31 July 1996 (BGBl. 1198), as last amended by Article 4 of the Regulation of 11 July 2006 (BGBl I). 1575).

Status:	New by Bek. v. 31.7.1996 I 1198;
	Last amended by Art. 4 V v. 11.7.2006 I 1575

For more details, please refer to the menu under Notes

Footnote

(+ + + Text evidence from: 1.8.1990 + + +) 

  

Unofficial table of contents

§ 1 Scope

This Regulation shall lay down detailed provisions on the nature, scope, content and form of communications to the Federal Institute for Risk Assessment,

1.

the person who places particular preparations or a biocidal product on the market in accordance with Article 16e (1) of the Chemicals Act,

2.

that a doctor has to hand in cases of poisoning in accordance with § 16e (2) of the Chemicals Act.

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§ 2 Obligation to provide information on the placing on the market of preparations and biocidal products
(Section 16e (1) of the Chemicals Act)

(1) The communication pursuant to § 16e (1) of the Chemicals Act has

1.

in the case of initial notification before the placing on the market, using the form referred to in Annex 1,

2.

in the event of a change notification, without delay, using the form in accordance with Annex 2, with the notification of the notification number issued by the Federal Institute for Risk Assessment

shall be made. In the case of a first communication, at least the information relating to points 1 to 8 of the form referred to in Appendix 1 shall be communicated. The Federal Institute for Risk Assessment (Bundesinstitut für Risk Assessment) confirms the notification of the notification and informs it of the corresponding notification number. (2) Any person who is preparing a preparation or a biocidal product, or as part of a preparation of his own, be placed on the market under its own trade name, the information referred to in point 3 of the form referred to in Appendix 1 may be indicated by a reference to the notification, including a notification of change of the manufacturer or importer of that preparation or of this Replace a biocidal product if it is the name and address of the manufacturer or (3) The Federal Institute for Risk Assessment may submit the information referred to in paragraphs 1 and 2, and the information provided by the Federal Institute for Risk Assessment shall be submitted to the 2 also allow on another suitable volume. Unofficial table of contents

§ 3 Medical notification obligation in the case of poisoning
(§ 16e para. 2 of the Chemicals Act)

(1) The communication pursuant to § 16e (2) of the Chemicals Act must be made using the form according to Appendix 3 and must include at least the information on points 1 to 4 of the form. She has

1.

in the case of acute diseases after completion of treatment,

2.

in the case of chronic diseases after diagnosis,

3.

in the case of counselling in connection with a disease after the conclusion of the consultation,

4.

if an induction is carried out in the case of a disease with a death sequence, after completion of the post-mortem

without delay. If an information and treatment centre for poisoning is to be provided for advice, a notification shall be made only by the attending physician. (2) The Federal Institute for Risk Assessment may also provide the information referred to in paragraph 1 in other appropriate ways. Unofficial table of contents

§ 4 Confidentiality

All data transmitted on the forms according to Appendices 1, 2 and 3, including the voluntary information, shall be treated as confidential. The information in the form according to Appendix 3 may not be processed or used for the manufacture of a person's reference to the patient. Unofficial table of contents

§ 5

(dropped) Unofficial table of contents

§ 6

(Entry into force) Unofficial table of contents

Appendix 1 (to § 2 para. 1 sentence 1 no. 1)

(Fundstelle: BGBl. I 2002, 2519-2521;
with regard to of the individual amendments. Footnote)

Please fill in clearly legible. 
  
To the 
Federal Institute for Risk Assessment 
Documentation and assessment body for poisoning 
Postfach 33 00 13 
14191 Berlin 
  
 Notification () of a preparation () of a biocidal product 
 (First announcement according to § 16e (1) of the Chemicals Act) 
  
 1. a) Name of the company, address 
 ................................................................. 
 b) Company telephone number 
 ................................................................. 
 (c) The competent authority of the company for information on the supply/ 
 the biocidal product 
 ................................................................. 
 Tel. No: ....................................................... 
 Tel.  after business conclusion .................................. 
 2. a) Trade name of the preparation/biocidal product 
 ................................................................. 
 (b) The preparation/biocidal product shall be the product of the participating company 
 ---- ---- 
 I I established I I introduced 
 ---- ---- 
 ---- 
 I I obtained from another company and unchanged in the 
 ---- Transport 
 3. Ingredients 
 (a) Special ingredients 
 Specify 
 (aa) biocidal active substances (in the case of communications on biocidal products); 
 (bb) very toxic, toxic, carcinogenic, fruit-damaging, 
 Mutagenic or sensitising substances from the 
 Concentration by which it is used to identify a preparation 
 or of a biocidal product, or at least 0.1%, 
 cc) strongly corrosive acids and alkalis, such as nitric acid, 
 hydrochloric acid, sulphuric acid, potassium hydroxide solution, sodium hydroxide solution, 
 as well as quaternary ammonium compounds and phenols 
 0,1% if these substances do not fall under aa or bb), 
 (dd) corrosive substances 
 at room temperature liquid 
 -halogenated hydrocarbons, 
 -Petrol distillates, including mixtures, under 
 Indication of the CAS numbers, 
 -Glykols, but not polyglycols, 
 from 1%, to the extent that these substances are not under aa), bb) or cc) 
 . 
 The concentration of the substance in the preparation/biocidal product 
 is to be given exactly (relative) to 10%.  As far as 
 shall be less than 5% and shall be used to assess the 
 Hazard potential of the preparation is not known 
 the exact concentration of the substance is necessary, 
 the concentration may be referred to in the following 
 Concentration levels are: up to 0.1%, 0.1% up to 
 less than 0.5%, 0.5% to less than 1.0%, 1.0% to less than 1.5%, 
 1.5% to below 2.0%, 2.0% to below 3.0%, 3.0% to below 
 4.0%, 4.0% to less than 5.0%.  In the case of production 
 the usual variations are also different 
 Concentration range information allowed. 
 ------------------------------------------------------------------------ 
 I Substances I CAS-I Concentration or  I R phrases I 
 I I, point I, concentration level I I 
 I ---------------------------------------------------------------------- I 
 I ----------------------- I -------- I --------------------- I --------------- I 
 I ----------------------- I -------- I --------------------- I --------------- I 
 I ----------------------- I -------- I --------------------- I --------------- I 
 I ----------------------- I -------- I --------------------- I --------------- I 
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 (b) Other ingredients 
 Indicate all other ingredients with a content 
 from 1.0 to 100 percent by weight. 
 Provided that the risk potential of the 
 Preparation/biocidal product does not know the knowledge of the individual 
 Substance is necessary and comparable physical/chemical 
 and toxicological properties, can take place 
 the name of the individual substance 
 group name are used, e.g. 
 -cationic surfactants, 
 -Anionic surfactants, 
 -non-ionic surfactants, 
 -fatty acids, 
 -Vegetable oils. 
 The concentration of the substance in the preparation/biocidal product 
 is to be given exactly (relative) to 20%.  As far as 
 of less than 10%, and to assess the 
 Risk potential of the preparation/biocidal product not the 
 knowledge of the precise concentration of the substance is necessary, 
 the concentration may be referred to in the following 
 concentration levels shall be from 1.0% to less than 2.0%, 
 2.0% to below 4.0%, 4.0% to below 7.0%, 7.0% to 7.0%, 
 below 10.0%.  In the case of normal production 
 Variations are also different 
 Concentration range information allowed. 
 ------------------------------------------------------------------------ 
 I Substances I CAS-I Concentration or  I R phrases I 
 I I, point I, concentration level I I 
 I ---------------------------------------------------------------------- I 
 I ----------------------- I -------- I --------------------- I --------------- I 
 I ----------------------- I -------- I --------------------- I --------------- I 
 I ----------------------- I -------- I --------------------- I --------------- I 
 I ----------------------- I -------- I --------------------- I --------------- I 
 ------------------------------------------------------------------------ 
 4. Labelling of the preparation 
 (a) danger symbols ......................................................... 
 (b) danger designations ........................................... 
 (c) indications of special hazards (R-phrases)... 
 ................................................................. 
 (d) Safety advice (S phrases) ................................ 
 ................................................................. 
 e) Other markings ......................................................... 
 ................................................................. 
 f) Classification 
 due to the examination of the preparation/biocidal product ........ 
 on the basis of calculation methods ............................... 
 ................................................................. 
 5. Use, intended use, and biocidal products 
 Main group and product type as defined in Annex V to Directive 98 /8/EC 
 in its latest in the Official Journal of the European 
 Communities published 
 .................................................................... 
 .................................................................... 
 6. Information on packaging 
 (a) In the form of packaging (  B. Dose, Spraydose, Bottle of 
 Screw cap, drip bottle, etc.) 
 ................................................................. 
 (b) Filed quantities (ml or g) .......................................... 
 ---- 
 c) I I The container carries a child-resistant closure 
 ---- 
 ---- 
 (d) I I The container carries a tactile warning sign 
 ---- 
 7. Recommendations on precautionary measures in the case of poisoning 
 and emergency measures in case of accidents 
 .................................................................... 
 .................................................................... 
 .................................................................... 
 8. pH of a mixture of water/preparation in a ratio of 1:1, 
 if the value is less than 2.5 or more than 10.0 
 .................................................................... 
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Additional information (voluntary) 
 9. Analysis of the most important ingredients (method, matrix) 
 .................................................................... 
10. Consistency of the preparation/biocidal product 
 (e.g.  B. Light-moving liquid, viscous, powder, 
 Paste, etc.) 
 .................................................................... 
11. Color of the preparation/biocidal product 
 .................................................................... 
12. Hazard reactions with other preparations/biocidal products, 
 which are intended for the consumer 
 .................................................................... 
13. Other information 
 ....................................................................   

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Appendix 2 (to § 2 para. 1 sentence 1 no. 2)

(Fundstelle: BGBl. I 2002, 2522;
with regard to of the individual amendment, see Footnote)

Please fill in clearly legible. 
  
To the 
Federal Institute for Risk Assessment 
Documentation and assessment body for poisoning 
Postfach 33 00 13 
14191 Berlin 
  
 Modification of a preparation/biocidal product 
 (Change announcement according to § 16e (1) of the Chemicals Act) 
  
A. Name of the company, address 
 ..................................................................... 
 Trade name of the preparation/biocidal product 
 ..................................................................... 
B. From the Federal Institute for Risk Assessment 
 Notified notification number 
 ................. 
 ---- 
C. I I The preparation/biocidal product shall be ... final 
 ---- no longer placed on the market. 
 ---- 
 I I The preparation/biocidal product will be ... for the first time 
 ---- placed on the market in the form shown below. 
D. Information on points 1 to 13 of the form for the first time 
 Communication on the last communication 
 changed.  Modified concentrations are only 
 indicate when the concentration of substances in the case of substances 
 3a) by more than 10%, for substances according to 3b) by more than 
 20% of the specified value (relative) has changed.  Is 
 an indication in one of the following (3a) or (3b) 
 concentration levels, is a change message 
 necessary when leaving this concentration level 
 .  Is due to normal fluctuations due to production 
 a concentration range is specified, a 
 Change announcement required if the specified 
 Concentration range has been abandoned. 
E. characteristics in which the original and the modified 
 Preparation/original and modified biocidal product 
 can be clearly distinguished (e.g.  B. Packaging code, color) 
 ..................................................................... 
 .....................................................................   

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Appendix 3 (to § 3 para. 1)

(Fundstelle: BGBl. I 2002, 2523;
with regard to of the individual amendments. Footnote)

Please fill in clearly legible. 
 ---------------------------------- 
 I I 
 I I 
To the I I 
Federal Institute for Risk Assessment I I 
Documentation and assessment body I I 
for poisoning I I 
Postfach 33 00 13 I I 
14191 Berlin I Original stamp, I 
 I Tel.  and I 
 I Signature of doctor I 
 I I 
 ---------------------------------- 
  
 Communication on poisoning 
 pursuant to Section 16e (2) of the Chemicals Act 
(BgVV: Phone: 01888 412-3460, Fax: 01888-412-3929, E-Mail: giftdok§bgvv.de) 
  
1. 
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I age ....  Years ---- Male ---- Female I Pregnancy: I 
I I I I I I ---- I 
I ---- ---- I I I Yes I 
I I ---- I 
I months ..... (for children under 3 years of age) I ---- I 
I I I No I 
I I ---- I 
------------------------------------------------------------------------------- 
 I Voluntary to fill out I 
 -------------------------- 
2. ---- Poisoning ---- Suspicion 
 I I I 
 ---- ---- 
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I Necessarily trade name of the preparation/biocidal product or I 
I shall indicate the name, quantity and manufacturer (distributor); I 
I possibly suspected cause 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 acute I I chronically 
 ---- ---- 
 ---- ---- ---- ---- ---- ---- 
 I I I I I I Skin I I I I eye (n) I I Other 
 ---- ---- ---- ---- ---- Which?  ... 
  
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I Etiology: ---- akzidentell ---- ---- I 
I I I (Accident) I I Industrial I I confusion I 
I ---- ---- ---- I 
I I 
I ---- suicidal ---- ---- ---- I 
I I I I I I I I I I I I I I I I I I I I I I I I 
I ---- ---- ---- ---- I 
I I 
I Location: ---- ---- ---- I 
I I I I I I I I I I I School I 
I ---- ---- ---- I 
I I 
I ---- ---- ---- I 
I I Kindergarten I I in the Free I I Other I 
I ---- ---- ---- I 
I I 
I Laboratory proof: ---- ---- I 
I I I Yes I No I 
I ---- ---- I 
I I 
I Treatment: ---- ---- ---- I 
I I no I I outpatient I I hospitalised I 
I ---- ---- ---- I 
I I 
I History: ---- ---- ---- ---- I 
I I I do not complete I I defect healing I I death I 
I ---- Known ---- Healing ---- ---- I 
I I 
I ---- I 
I I I Spätdamages (not excluded) I 
I ---- I 
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 I Voluntary to fill out I 
 -------------------------------- 
  
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I 4.  Symptoms/History (click) I 
I may be  Anonymized findings, epidemic (s) I 
I I 
I I 
I I 
I I 
I I 
I I 
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