Update on the Biocidal Products Regulation...
Transcript of Update on the Biocidal Products Regulation...
Update on the Biocidal Products Regulation (BPR)Formulators, importers and distributors of disinfection products
Michael Fink, DHI, Denmark5th of May 2015SEPAWA NordicRadisson Blu Hotel, Malmö
DHI Environment and Toxicology (EAT)
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International consulting and research organisation within water, environment and health
Supporting industry in keeping chemical products compliant with regulation
Human and environmental risk assessments
Chemicals and consumer products
Biocides and pesticides
Marine waste and ballast water
Food, feed, cosmetics
IT and chemical management
Pharmaceuticals and medical devices
Water safety and contaminants
DHI Environment and Toxicology- Biocides
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Biocidal-team of 15 persons
• Scoping of projects and cost analysis
• Data gap analysis
• Testings and studies
• Exposure and risk assessments
• IUCLID
• Authorisations
• Art. 95 listings
• Authority contact, MS, ECHA
Michael Fink
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Biologist, from 2008 at DHI-EAT
Danish/German
Risk assessment of biocidal actives and products
Strategic advice to industry
Researchprojects: Disinfection (Efficacy, safety, resistance)
Course leader: Authorisation of biocidal products
www.tox.dhigroup.com
Agenda
1. The BPR and disinfectants
2. Status of the active substances of disinfectants
3. Important deadline: 1. September 2015- Article 95
4. Opportunity: Biocidal product family
5. Procedures and costs within the BPR
6. Recommendations
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1. The BPR and disinfectants
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Main purpose of BPR
• Biocidal products are safe for humans, animals and the environment
• Biocidal products are sufficiently effective
• Harmonisation of rules concerning
• Making available of biocidal products on the market
• Use of biocidal products
• Evaluation of biocidal products
1. The BPR and disinfectants
Large amount of biocidal products on the market
• Germany: > 36.000 products registered
• France: > 27.000 products registered
• Denmark: > 2.000 products (300 registered)
Huge variation of products (22 Product types)
• Disinfection products (PT1-5) the largest
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1. The BPR and disinfectants
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Approval process of biocidal products:
Active substance(s) sets the pace
a. Evaluation and approval of active substance (AS)
b. Authorisation of biocidal product containing the AS
2. Status of the active substances of disinfectants
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BPC= Biocidal Products Committee
Detailed work programme with 2-year visibility
2. Status of the active substances of disinfectants
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Active substance Status: approved
Iodine PT1, PT3, PT4, PT22
Application deadline 1. September 2015
Propan-2-ol PT 1, PT2, PT4
Application deadline 1. July 2016
And more to come soon PT1, PT2, PT3, PT4, PT6
2. Status of the active substances of disinfectants
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Selected active substances Status: soon to be approved
Glutaraldehyde PT 2, PT3, PT4; BPC opinion published
Hydrogen peroxide PT1-6; BPC opinion published
C(M)IT/MIT PT6, PT11; BPC opinion published
PAA PT1-6; BPC opinion published
PHMB PT1-4, PT6; on the table BPC June 2015
DDAC PT 8; on the table BPC June 2015
BKC PT 8; on the table BPC June 2015
Bardap 26 PT 8; on the table BPC September 2015
Ethanol PT1, PT2, PT4; on the table BPC December 2015
NaClO PT1-5; on the table BPC February 2016
CaClO, Chlorine PT2, PT5; on the table BPC February 2016
2. Status of the active substances of disinfectants
Status of actives
• http://echa.europa.eu/web/guest/information-on-chemicals/biocidal-active-substances
BPC work programme
• http://echa.europa.eu/about-us/who-we-are/biocidal-products-committee
Contact active substance supplier
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3. Important deadline: 1. September 2015- Article 95
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From 1. September 2015, a biocidal product consisting of,
containing, or generating a relevant substance, cannot be made
available on the EU market
- if the substance supplier or product supplier is not included in
the list for the product type to which the product belongs.
3. Important deadline: 1. September 2015- Article 95
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Biocidal products which do not comply with art. 95 will be illegal on the market after 1.
September 2015- no period of grace.
Alternative active substance suppliers, that have not contributed to the
reviewprogramme, must be listed in order to continue to market biocidal active
substance.
The obligation of art. 95 lies within the supply chain
3. Important deadline: 1. September 2015- Article 95
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Variations
Formulators and importers of biocidal products can be in a situation where they have to
get listed, since their active substance suppliers are not!
Producers of certain precursors to in situ generated active substances must also be listed
in order to market the precursors for biocidal use.
Listing has to be applied to ECHA
• Active substance supplier
• Product supplier
3. Important deadline: 1. September 2015- Article 95
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How to get listed:
LoA to complete dossier
ECHA fee 2.000 EUR
Own complete dossier, mix of own data and LoA to data from complete dossier
ECHA fee 20.000 EUR
Own complete dossier, own data
ECHA fee 40.000 EUR
4. Opportunity: Biocidal product family
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New biocidal product family concept
A biocidal product family refers to a group of products
• having similar uses,
• the same active substances,
• similar composition within specified variations and
• similar levels of risk and
• efficacy
4. Opportunity: Biocidal product family
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New biocidal product family concept
All products within the biocidal product family are covered by one authorisation for the
family as a whole rather than each individual product requiring authorisation.
Each product within the biocidal product family will have a suffix to the authorisation
number
New products can be added to the family if they fall within the existing ranges of the
biocidal product family authorisation
Opportunity for disinfection products
5. Procedures and costs within the BPR
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• National authorisations and
mutual recognition
• First approvals of own
formulations
Biocidal product
Biocidal product family
5. Procedures and costs within the BPR
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• National authorisation of
identical product
• Refers to already approved
biocidal product
Biocidal product
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Own biocidal products/BPF Identical biocidal products
Full IPR No IPR
1 year 90 - 120 days
LoA on active(s) No LoA on active(s)
Full data package No data package
Fee to MS CA:
1. MS 5.000 - 50.000 EUR
MR 1.000 - 16.000 EUR
Fee to MS CA:
1.500 – 3.000 EUR
Fee to ECHA for MR:
700 EUR pr. MS
No fee to ECHA
5. Procedures and costs within the BPR
Abbreviations: BPF = Biocidal product family; IPR = Intellectual property rights; LoA= Letter of
Access; MS= Member State; CA= Competent authority; MR= Mutual recognition
6. Recommendations
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1. priority: Art. 95 list of approved substance suppliers
• Check supply chain before September 2015 deadline
• For all biocidal products
• No period of grace
6. Recommendations
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• Leave biocidal market
• Plan your exit
• Stay #1
• Authorisation of identical products
• Buy into approved formulations and keep customers
• Less costs
• Private label
6. Recommendations
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• Stay #2
• Authorisation of own products
• Reduce costs- strategic and cost efficient regulatory projects
• Get the most out of the LoA
• Choose the right MS
• Invest in few but solid product dossiers
• Exploit biocidal product family concept
• Invest only in data or studies when really needed
• Sell access to approved formulations