changes of biocidal products: national...

Changes of Biocidal Products: National Experiences

Maristella Rubbiani National Center for Chemicals

Istituto Superiore di Sanità

Roma - Italia

27/05/2014 Maristella Rubbiani-ISS-Roma, Italy 2

Overall national system in place and range of product types covered

The assessment of a product under the national system is provided exclusively by authorization procedures currently released only for four PTs (other product types are free market), called “Presidi Medico Chirurgici” This system has been in force since 1998, formerly under other authorization procedure

Procedure for national authorization

The procedure for the authorization to place on the market is provided by Presidential Decree 392 of 1998, which lists the following types of products and Provision of the Ministry of Health of 5 February 1999

disinfectants and products placed on the market such as

germicides, bactericides, virucides, microbicides, fungicides;

insecticides;

insect repellents;

rodenticides;


Transitional period

In the transitional period, Italian national procedure for placing on the market biocidal products are currently only for product types 1,2,3,4,5,14, 18 and 19, corresponding to the previously mentioned categories.


Authorization procedure


Administrative evaluation by Ministry of Health Scientific evaluation by Istituto Superiore di Sanità Authorization granted by Ministry of Health Authorization lasts unlimited Approval is granted by a decree Since BPD/BPR is in force, active substances should be under the rewiew program


Requirements: Company name, registered office, applicant name Intended product name Qualitative-quantitative composition Physical form of the product; Intended use of the product; Typical properties of the components justifying their use; Analysis certificate Method for determination of a.i.and validation of the method Efficacy trials Acute toxicity tests or Conventional method for C&L SDSs of the dangerous components Stability trials Labelling proposaluse method and dosage; Expiry date for use; Sale sizes; Information on authorized production /formulation site* *currently the definition of “authorized site” is released as a consequence of certification/enforcement (approval by Ministry of Health)

Requirements Waiting for the inclusion of the substances subject to review

by the application of the BPD/BPR , active ingredient(s) contained in the formulation must be notified and supported according to the EU list

Specific toxicological/ecotoxicological information are not necessary on the a.i. and test are not necessary on the product; classification is carried out by the conventional calculation method, according to Directive 99/45/EU and successive adaptations.

If test are presented, they should be performed according to GLP and OECD guidelines or CLP requirements.

Efficacy test are exempted, they should be performed according to EU standards

Toxicity test performed after 28 February 2006 should be authorized.

Environmental test are not required;


Requirements, cont’d

Other requirements are: complete quali-quantitative composition of the product; certificate of analysis and analytical method for the qualitative/quantitative control of the a.i. or the a.is present in the product formulation; data on physical-chemical properties.

Activity/effectiveness/efficacy of the product should be performed on the product and the data must respect the real conditions of use, according to European guidelines where applicable.

Stability (shelf life) of the product should be carried out in shelf life test at room temp. or accelerated (CIPAC methods )

Two copies of the proposed labels in Italian should be included in the application as well as the safety data sheets of all the dangerous components.

A CLP proposal should be also welcomed

The original documentation has to be provided to Ministry of Health and as a copy to Istituto Superiore di Sanità (ISS).


Requirements, cont’d The labeling and packaging of the product must be respective of

existing legislation.

Once approved, the label and printed matter must bear the wording “Presidi Medico Chirurgici” and “Registration of the Ministry of Health no. .....” and will form part of the decree for the authorization of marketing.

Subsequent change to printed matter must be subject to ad hoc application, according to the set up criteria, and must be authorized, even in the case anticipations of binding future regulations.

A declaration, with certified signature, of the technical manager of the production plant(s) certifying the suitability to produce/ prepare/package/controlling should be provided with the specification.


Letter of Access

If the applicant intends to make use of all or some of the documents drafted by another company for the authorization, these documents can be replaced by a letter of access, with the signature proofed by the legal representative of the company that drafted the documentation, declaring faculty of using these documents .



National marketing timeline following inclusion or non-inclusion decisions for existing “national” authorisation -Remaining time to apply for removing national authorisation or changes to existing national authorisations in regard to the date of non inclusion of active substances in AnnexI/IA of the BPD/BPR

- 1 year for removal OR modification since date reported in the non inclusion decision, the same for sale of existing stocks -Remaining time to apply for national authorisation or changes to existing national authorisations in regard to the date of inclusion of active substances in AnnexI/IA of the BPD

->Within the date of inclusion reported in the Directive -> Removal from the market : 6 months after inclusion date plus additional 6 months for sale of existing stocks


National consequences following first authorisations or mutual recognitions for existing “national” authorisations Immediate expiring of the “previous” product already authorized at national level (if identical and authorized for the same PT) In the authorization decree as Biocidal product, also the “recognized death” of the previous identical PMC/free market product is reported. One year for complete stock removal Few modifications allowed in order to align the previous product to the biocidal one

How long is the transition to take?

For individual products, the transitional period will take until the date of inclusion of the last active substance contained in a given product.

With the last re-authorization of the last product/PT combination, the transitional process will be finalised.


Authorization under current system and changes

Year New authorizations Modifications

2011 167 51

2012 159 58

2013 156 158

Increased number of product changes due to:

• Replacement of active substances no longer supported/included

• Changes due to alignement to the representative product

• Changes due to new C&L of components


Product modification due to:

Active ingredient replacement or

Active ingredient % replacement

Different claim

Additional RMMs

New Size and packaging

Co- formulating agents replacement

New C&L

Active ingredients replacements could lead to:

Claim modification (es. according to different efficacy properties)

Classification and labelling modification(es. according to different classification of the a.s.)

Type of formulation modification

Size and type of the packaging modification

Rate of application modification

Target modification according to a.i. properties

Efficacy % according to a.i. properties

I.e. Insecticides :

Substitution of some pyrethroids no longer supported with other

similar but not perfectly overlapping

After modification of ingredients, additional studies/documents should be newly performed

Usually (at least):

Efficacy

Storage stability

C&L

Label and Sds

Modification for new introduced RMMs

According to inclusion directive for aaiis, if additional RMMs have been proposed, they could affect for example:

Category of users (by professional, non professional)

Condition of use (domestic, civil, industrial)

Type of packaging (bait, no powder, ecc)

Site of use (in around building, sewage, ecc)

Additional obligatory components (dye or bittering or emetic agents)

Additional good practice information

Size (according to category of users)

Labelling

Sds

Current state of authorization and mutual recognition in Italy

Italy: application received*

* 30 April 2014 (R4BP)

569

CURRENT SITUATION (ISS)

Authorization applications received: 192 Under evaluation: 33 Evaluated: 159

Mutual recognition applications: 106 Under evaluation: 21 Evaluated: 85

* 30 April 2014 (R4BP)

Authorizations

MR Auth.

Application for a change toan authorised/registeredproduct

350 (61,5%)

1 (0,2%)

218 (38,3%)

APPLICATIONS (R4BP)

020406080

100120140

Auth.MR

72/48 73/55 52/20 8/18 0/15 4/58 0/7 0/5 9/124

CURRENT SITUATION (IT)*:

* 30 April 2014 (R4BP)

2010 : 42 2011 : 87 1 MR 20 MR 41 Authorizations 67 Authorizations

2012 : 93 2013 : 76 30 MR 55 MR 63 Authorizations 21 Authorizations

2014 : 8

2 Authorizations/6 Mutual Recognition

CURRENT SITUATION (ISS) TREND OF APPLICATION

CURRENT SITUATION (ISS) PRODUCT TYPES

PT 14 (Rodenticides) ► 261 PT 8 (Wood Preservatives) ► 18 PT 18 (Insecticides..) ► 6 PT 19 (Repellents/Attractants)► 9

0102030405060708090

100 86 89 55 4 7 7 2 1 4 2

PRODUCT TYPE 14

0

2

4

6

8

10

12

14 1 13 1 2 1

PRODUCT TYPE 8

0123456789

10

PT 18PT 19

PRODUCT TYPE 18 - 19

2 1 1 1 1 9


Authorization fees National procedure: 1200€ for MoH +2500€ for ISS = 3700 € Biocide authorization now: 2500€ Biocide authorization future : 10000€

Conclusions Several modification according to :

Introduction of new RMMs

Active ingredients replacement

Formulation type modification

Consequences:

Removal from the market

Possible impact on national/eu market

Additional workload

Additional expenses

Perspective:

Additional replacement and substitution deriving from application of cut-off criteria and candidate to substitution criteria

Future improvement at national level

• National database for biocidal products • Enforcement and control programs for biocidal

products • Identification of professional users

• Updating Fees

• National action plan for implementation of Sustainable Use Directive (Training/Formation/Information)

• Establishing a national helpdesk


Further info on Ministero della salute website: www.ministerosalute.it/ biocidi/ Tank you for your attention!

http://www.ministerosalute.it/

http://www.ministerosalute.it/biocidi/

http://www.ministerosalute.it/biocidi/

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