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

Non-official Table of Contents

ChemGiftInfoV

Date of expiry: 17.07.1990

Full quote:

" Poison Information Regulation in the version of the notice of 31 December 2014. July 1996 (BGBl. 1198), as last amended by Article 4 of the Regulation of 11 June 1998. July 2006 (BGBl. I p. 1575) "

:Recaught by Bek. v. 31.7.1996 I 1198;
last modified by Art. 4 V v. 11.7.2006 I 1575

See Notes

Footnote

(+ + + Text Evidence: 1.8.1990 + + +)

for details on the stand specification. name="BJNR014240990BJNE000204308 " />Non-Official Table of Contents

§ 1 Scope

This Regulation applies detailed provisions on the nature, scope, content and form of communications to the Federal Institute for Risk Assessment,
1.
the one who has certain preparations or a Placing a biocidal product on the market, according to § 16e (1) of the Chemicals Act,
2.
which a doctor is responsible for in accordance with § 16e (2) of the Chemicals Act
Non-official table of contents

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

(1) The communication according to § 16e paragraph 1 of the Chemicals Act has
1.
in the first release before placing on the market using the form according to Appendix 1,
2.
in case of change notification, immediately using the form according to Appendix 2, mentioning the notification number issued by the Federal Institute for Risk Assessment
shall be given. 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 shall confirm the receipt of the notification to the notified body and inform it of the corresponding notification number.(2) Anyone who places a preparation or a biocidal product on the market, either unchanged or as part of its own preparation under its own trade name, may refer to point 3 of the form referred to in Appendix 1 by a reference to the Replace notification, including a notification of change of the manufacturer or importer of this preparation or of this biocidal product, if he/she is the name and address of the manufacturer or importer, the trade name of the preparation or of the Biocidal product as well as the notification number issued by the Federal Institute for Risk Assessment.(3) The Federal Institute for Risk Assessment may also authorise the transmission of the information referred to in paragraphs 1 and 2 on another suitable medium. Non-official table of contents

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

(1) The notification according 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. It has
1.
for acute illness after completion of treatment,
2.
in case of chronic illness after diagnosis,
3.
in case of advice related to a After consulting,
4.
if an obduction is carried out in the event of a death, after completion
the disease
immediately shall be given. If an information and treatment centre for poisoning is to be used for consultation, a notification shall be made only by the treating physician.(2) The Federal Institute for Risk Assessment may also authorise the transmission of the information referred to in paragraph 1 in other appropriate ways. Non-official table of contents

§ 4 Confidentiality

All data transmitted on the forms after assets 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

(omitted) unofficial Table of Contents

§ 6

(Entry into force) Non-official table of contents

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

(Fundstelle: BGBl. I 2002, 2519-2521;
of the individual amendments, cf. Footnote)
Please fill in clearly.

To the
Federal Institute for Risk Assessment
Document and Evaluation Center for Poisoning
Postfach 33 00 13
14191 Berlin

Notification () of a preparation () of a biocidal product
(first notification according to § 16e (1) of the Chemicals Act)

1. (a) Name of the company, address
.............................................................
b) Telephone number of the company
..........................................................
c) Permanent position of the company Company for information about the preparation/
the biocidal product
...........................................................
Tel. -No.: .......................................................
Tel. -No. after Business closure ..................................
2. (a) The trade name of the preparation/biocidal product
.............................................................
b) The preparation/biocidal product shall be produced by the participating company
---- ----
I I established I I introduced
---- ----
----
I I moved from another company and unchanged in the
---- traffic brought
3. Ingredients
a) Special ingredients
Admitting are
aa) Biocidal active substances (in the case of communications on biocidal products),
bb) very toxic, toxic, carcinogenic, fruit-damaging,
acid-changing or sensitizing substances from the
of concentration at which they contribute to the labelling of a preparation
or of a biocidal product, but at least from 0.1%,
cc) of highly corrosive acids, and Laughs, such as nitric acid,
Hydrochloric acid, sulphuric acid, potassium hydroxide solution, sodium hydroxide solution,
and quaternary ammonium compounds and phenols from
0.1%, unless these substances fall under aa or bb),
dd) corrosive substances
at room temperature liquid
halogenated hydrocarbons,
petroldistillates including mixtures on
indication of CAS numbers,
glycols, but not Polyglycols,
from 1% if these substances do not fall under aa), bb) or cc)
.
The concentration of the substance in the preparation/biocidal product
is to be reported exactly (relative to 10%). To the extent that the contents of
must be less than 5%, and if
of the exact concentration of the substance is not necessary to assess the
hazard potential of the preparation,
may indicate the concentration in the following
concentration levels: up to 0.1%, 0.1% to
below 0.5%, 0.5% to below 1.0%, 1.0% to below 1.5%,
1.5% to below 2.0%, 2.0% to below 3.0%, 3.0% to less than
4.0%, 4.0% to below 5.0%. For production-related
variations, different
concentration ranges are also allowed.
------------------------------------------------------------------------
I Substances I CAS-I concentration or I R-Sphrases I
I I Number 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
All other ingredients are added to an
content of from 1.0 to 100 percent by weight.
If the hazard potential of the
preparation/biocidal product is assessed, knowledge of the individual
substance is not necessary and comparable physical/chemical
and toxicological properties, instead of
the designation of the individual substance can be related to a
group name, 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 reported exactly (relative to 20%). To the extent that the
is less than 10%, and if the
is not aware of the exact concentration of the substance to assess the
potential of the preparation/biocidal product, the
may be Concentration is given in the following
concentration levels: 1.0% to below 2.0%,
2.0% to below 4.0%, 4.0% to 7.0%, 7.0% to
, below 10.0%. For production-related
variations, different
concentration ranges are also allowed.
------------------------------------------------------------------------
I Substances I CAS-I concentration or I R-Sphrases I
I I Number 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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4. Labelling of the preparation
a) danger symbols .........................................................
b) danger designations ...........................................
c) special hazards (R-phrases) .......................
.................................................................
d) Safety advice (S-phrases) .................................
.............................................................
e) More labels .........................................................
.............................................................
f) Classification
Due to the examination of the preparation/biocidal product ........
due to calculation methods ................................
..........................................................
5. Type of use, intended use, and biocidal products
The main group and type of product listed in Annex V to Directive 98 /8/EC
in their latest version, published in the Official Journal of the European
Communities,
....................................................................
....................................................................
6. Information on packaging
a) Packaging (e. g. B. can, spray can, bottle with
screw cap, drip bottle, etc.)
.............................................................
b) Filed quantities (ml or g) ..........................................
----
c) I I The bundle carries a child-proof closure
----
----
d) I I The container carries a tactile warning sign
----
7. Recommendations on precautions for poisoning
and emergency measures in the event of accidents
....................................................................
........................................................................
....................................................................
8. pH value 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
.........................................................................
------------------------------------------------------------------------
Additional information (optional)
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. Dangerous reactions with other preparations/biocidal products,
that are intended for the consumer
....................................................................
13. Other information
....................................................................
unofficial table of contents

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

(site of reference: BGBl. I 2002, 2522;
of the individual amendment, cf. Footnote)
Please fill in clearly.

To the
Federal Institute for Risk Assessment
Document and Evaluation Center for Poisoning
Postfach 33 00 13
14191 Berlin

Change announcement of a preparation/biocidal product
(change of communication according to § 16e para. 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
Shared Number
.................
----
C. I I The preparation/biocidal product shall be taken from ... finally
---- no longer placed on the market.
----
I I The preparation/biocidal product will be released from the ... for the first time
---- is placed on the market in the form below.
D. Information on numbers 1 to 13 of the form for the first time
notice that has changed from the last message
. Modified concentrations are to be specified only
the concentration of substances according to
3a) has changed by more than 10%, for substances in accordance with 3b) by more than
20% of the given value (relative). If
is specified in one of the
concentration levels specified in 3a) or 3b), then a change message
is required if this concentration level has been left
. If a concentration range is specified because of production-related fluctuations
, a
change message is required if the specified
concentration range has been abandoned.
E. Properties where the clearly distinguishing the original and modified
preparation (s) and the modified biocidal product
s)
(e.g. B. Packaging Code, Color)
.....................................................................
.....................................................................
Non-official table of contents

Appendix 3 (to § 3 para. 1)

(Fundstelle: BGBl. I 2002, 2523;
of the individual amendments, cf. Footnote)
Please fill out clearly.
----------------------------------
I I
I
To the I I
Federal Institute for Risk Assessment I
Documentation-and Rating point I I
for poisoning I I
Postfach 33 00 13 I I
14191 Berlin I Original stamp, I
I Tel. -No. and I
I Signature of doctor I
I I
----------------------------------

Communication on poisoning
according to § 16e paragraph 2 of the Chemicals Act
(BgVV: Phone: 01888 412-3460, Fax: 01888-412-3929, Email: giftdok§bgvv.de)

1.
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I Alter .... Years ---- Male ---- Female I Pregnancy: 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 I No I
I I ---- I
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I Volunteer I
--------------------------
2. ---- Poisoning ---- Suspected
I I I I
---- ----
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I Unconditional trade name of the preparation/biocidal product or I
I fabric name, included quantity and manufacturer (distributor) specify; 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. Exposure: ---- ----
I I am acute I I chronically
---- ----
---- ---- ---- ----
I I I I oral I I inhalative I I skin I I Eye (s) I I Other
---- ---- ---- ---- ---- Which? ...

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I Etiologie: ---- aczidentell ---- ---- I
I I I (Accident) I I Commercial I I Change 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 Location: ---- ---- ---- I
I I I I I I I I I I I I School I
I ---- ---- ---- I
I
I ---- ---- ---- I
I I I I I I I I I I am outdoors I I I
I ---- ---- ---- I
I I
I Labor-Proof: ---- ---- I
I I Yes I No I
I ---- ---- I
I I
I Treatment: ---- ---- I
I I I I I I I do not outpatient I I outpatient I
I
I ---- ---- ---- I
I
I History: ---- ---- ---- ---- I
I I I I do not I I complete I I defect healing I I Death I
I ---- Known ---- Healing ---- ---- I
I I
I ---- I
I I Spätdamages (not excluded) I
I ---- I
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I Volunteer I
--------------------------------

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I 4. Symptoms/History (keyword) I
I may be Anonymized findings, epic crisis (s) I
I
I I
I
I I
I I
I
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