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)

#2

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

#3

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

#4

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

#5

01.

The BPR and disinfectants

#6

1. The BPR and disinfectants

#7

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

#8

1. The BPR and disinfectants

#9

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

02.

Status of the active substances of disinfectants

#10

2. Status of the active substances of disinfectants

#11

BPC= Biocidal Products Committee

Detailed work programme with 2-year visibility

2. Status of the active substances of disinfectants

#12

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

#13

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

#14

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

#15

03.

Important deadline: 1. September 2015- Article 95

#16

3. Important deadline: 1. September 2015- Article 95

#17

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

#18

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

#19

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

#20

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

04.

Opportunity: Biocidal product family

#21

4. Opportunity: Biocidal product family

#22

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

#23

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

05.

Procedures and costs within the BPR

#24

5. Procedures and costs within the BPR

#25

• National authorisations and

mutual recognition

• First approvals of own

formulations

Biocidal product

Biocidal product family

5. Procedures and costs within the BPR

#26

• National authorisation of

identical product

• Refers to already approved

biocidal product

Biocidal product

#27

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

06.

Recommendations

#28

6. Recommendations

#29

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

#30

• 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

#31

• 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

Thank you for your attention

Michael Fink, DHI, Denmark

mif@dhigroup.com

+45 4516 9156