Biocides: authorization or notification
General comments:
If multiple product types and multiple uses are requested for a single product (e.g. PT1 and 2 or PT7 and 11) and if one of the requested product type or one
of the requested use requests an authorization (e.g. PT2 and TP11), a complete request of AUTHORIZATION has to be submitted for ALL product types and
uses requested for the concerned product. The reason is that it’s not possible to attribute a notification and an authorization number at the same time for
a product which carries the same commercial name.
In this case, the society who introduces the request must:
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Indicate in the part “A10” of the electronic dossier (B10) which PT requests an authorization and which PT requests a notification. For the PTs which
request a notification (e.g. stability test), the requested tests must not be submitted.
Select in the electronic dossier ALL PT’s for which the product is allocated (PT’s requested an authorization but also PT’s requested a notification).
Indicate only efficacy data for the PT’s for which an authorization is requested.
Submit a label where ALL requested PT’s are mentioned.
1
Biocides: authorization or notification
Group/Product Type
GROUP 1 : Disinfectants
and general biocides
PT 1 : Human Hygiene
biocides
PT2: Private area and
public health area
disinfectants and other
biocides
PT3: Veterinary Hygiene
Biocides
Justification for autorisation
procedure
Justification for notification
procedure
Other comments
Source
Not described in R.D of 1975.
Authorization not required
To be notified.
Examples (in general): disinfectant
for the skin, alcohol based gel (60
to 80% V/V), soap with
antibacterial/antiseptic/disinfectant
properties mentioned (= biocidal
claims)
Guidelines with regard to
the borderline between
biocides – cosmetics and
medicines for human use
(Joint Committee
17/06/2010)
To be authorized: since and
according the R.D of 1975
/
Depending on the claims,
composition and destination, a
product can be biocide or
medicinal product or cosmetic
Recommendation: If in doubt with
regard to the classification, please
check the document of the joint
committee on the website under
“borderline”
/
Authorization required
according to R.D. of 1975 for
products that:
Notification for products to be
applied on the skin of animals.
Depending on the claims,
composition and destination, a
product to be used on the skin of
an animal can be biocide or
medicinal veterinary product. The
biocidal products cannot be
claimed to have preventive and/or
therapeutical indications.
Explanation on the
borderline issue; biocideveterinary medicinal
product (Joint Committee;
17/06/2010) ; R.D. of
05/06/1975)
« Fight or eliminate pest animals,
plants or microorganisms in
housing, buildings, means of
transportation, swimming pools,
rubbish dumps and sewers. (c) »
→ hygiene for animals, use on
surfaces
Royal Decree of 05 June
1975
Specific case: Udder hygiene
Biocide: product used to cleanse
and sanitize udders before milking
but not to prevent mastitis or
infections. The udder must be
2
Biocides: authorization or notification
Group/Product Type
Justification for autorisation
procedure
Justification for notification
procedure
Other comments
Source
PT4 : Food and feed area
disinfectants
To be authorized: since and
according the R.D of 1975 (a)
/
cleaned and dried before the
milking process (must be indicated
on the label)  Notification
requiredVeterinary product:
product used to soak or spray the
udder after the milking process in
order to prevent mastitis and
infections.  Veterinary product
authorisation required.Remark: If
the product is destined to be used
before and after the milking
process then it will be considered
to be a veterinary product , thus
requiring an authorization as
veterinary product..
/
PT5: Drinking water
disinfectants
To be authorized: since and
according the R.D of 1975 (e)
/
/
Royal Decree of 05 June
1975
To be authorized: since and
according the R.D of 1975 (k + j
for certain products)
Exception: notification for products
that prevent the decomposition of
non-industrial aqueous products
and their adjuvants.
/
Royal Decree of 05 June
1975 (modified by R.D. of
5/11/1991);
R.D of 12
March 2010
PT7: Film preservatives
Not described in R.D of 1975.
Notification required
/
R.D of 12 March 2010;
Manual of decisions
PT8: Wood preservatives
To be authorized: since and
according the R.D of 1975 (c)
/
/
Royal Decree of 05 June
1975
GROUP 2: Preservatives
PT6: In-can preservatives
Royal Decree of 05 June
1975
3
Biocides: authorization or notification
Group/Product Type
Justification for autorisation
procedure
Justification for notification
procedure
Other comments
Source
PT9: Fiber, leather,
rubber and polymerized
materials preservatives
To be authorized: since and
according the R.D of 1975 (d,h
& k)
/
/
Royal Decree of 05 June
1975 (modified by R.D. of
5/11/1991)
PT10: Masonry
preservatives
To be authorized: since and
according the R.D of 1975 (c &
d)
Royal Decree of 5 June
1975 (amended by R.D.
5/11/1991); R.D.
12/03/2010
PT11: Preservatives for
liquid-cooling and
processing systems
Notification for preventive
/
products applied in the form of a
film or layer (up to 1 to 2 cm in
thickness) on building surfaces (e.g.
layer of cement, plaster for external
use)
/
/
Authorization required.
According to R.D. of 1975
(amended by R.D. of
5/11/1991):
Products used for treatment of
industrial water to fight or
eliminate animals, plants or
microorganisms (i)
→ to be authorized.
Examples:
- Products used in
recirculating water processes
in paper and paperboard
industry
- Products used in closed
recirculating cool water
systems
Authorization required
/
according to R.D. of 1975
(amended by R.D. of
PT12: Slimicides
According to the manual of
decisions (59), PT6 is the most
appropriate for biocidal products
Royal Decree of 05 June
1975 (amended by R.D.
5/11/1991)
Royal Decree of 05 June
1975 (modified by R.D. of
5/11/1991); Manual of
4
Biocides: authorization or notification
Group/Product Type
PT13: Metal workingfluid preservatives
GROUP 3: Pest Control
PT14: Rodenticides
PT15: Avicides
PT16: Molluscicides
PT17: Piscicides
PT18: Insecticides,
acaricides and products
to control other
arthropods
PT19: Repellent and
Justification for autorisation
procedure
5/11/1991):
Products to prevent the
decomposition of industrial
water products and their
adjuvants (j)
Justification for notification
procedure
Other comments
Source
decisions
/
used in the storage of other raw
materials in paper mill (e.g. starch
before its cooking) and prior to the
supply of raw materials to a paper
mill (e.g. during transport).
Preservation of paper itself or
other final products belongs to
PT9. PT12 is suited for product
used in industrial processes, e.g.
paper industry. As a general rule,
biocidal products used at the wetend of a paper machine would be
regarded as PT 12, whilst those
used at the dry-end would be
regarded as PT 6.
/
To be authorized: since and
according the R.D of 1975 (j)
To be authorized: since and
according the R.D of 1975 (c)
Not described in R.D. of 1975
Authorization not required.
Not described in R.D. of 1975
Authorization not required.
Not described in R.D. of 1975
Authorization not required.
To be authorized: since and
according the R.D of 1975 (c)
/
/
Royal Decree of 05 June
1975
Notification required
/
Royal Decree of 12 March
2010
Notification required
/
Royal Decree of 12 March
2010
Notification required
/
Royal Decree of 12 March
2010
/
/
Royal Decree of 05 June
1975
To be authorized: since and
Notification required for products
/
Royal Decree of 05 June
R.D. of 05 june 1975
5
Biocides: authorization or notification
Group/Product Type
Justification for autorisation
procedure
according the R.D of 1975
(c & f)
e.g.: products for use on
surfaces (c); products for use
on pet skin (cats, rabbits, dogs,
etc.) (f)
Justification for notification
procedure
used on the human skin and for
parasite repellent bracelets.
GROUP 4 : Other
biocides
PT20: Preservatives for
food or feedstock’s
To be authorized: since and
according the R.D of 1975 (b)
/
/
Royal Decree of 05 June
1975
PT21: Antifouling
products
To be authorized: since and
according the R.D of 1975 (g)
/
/
Royal Decree of 05 June
1975
PT22: Embalming and
taxidermist fluids
Not described in R.D. 1975
Authorization not required
Notification required
/
Royal Decree of 12 March
2010
PT23: Control of other
vertebrates
Other: In situ generated
active substances
Not described in R.D. 1975
Authorization not required
Not described in R.D. 1975
Authorization not required
Notification required
/
Royal Decree of 12 March
2010
Notification required
/
Royal Decree of 12 march
2010
attractants
Other comments
Source
1975 ; Royal Decree of 12
march 2010
Notification required for products
used on the skin of large pets
(horses, goat, sheep, etc.)
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Biocides: authorization or notification