We will ensure your continous compliance with Biocide regulation so you can focus on your everyday job.
Most likely you are one of those employees with endless tasks at hand, who performs his/her job with strong responsibility and integrity. Otherwise you would not have been chosen to manage the tasks related to biocides. Despite the fact that you have demonstrated your expertise and responsible attitude time and time again, with regards to biocides even you have doubts sometimes. This is comes as no surprise, of course. Even though you may be able to read the 200-page description of the Regulation in your own language, it is certainly difficult to find time to study the over 500 page long English language guidance. In the case that you manage to participate in biocides conferences, you may receive the guidelines, but the work itself is still waiting for you to complete at home.
Good BIOCIDE strategy = Profitability, Staying in Business.
Bad BIOCIDE Strategy = Financial Loss
As a responsible representative, you are well aware of the fact that with a good biocide strategy you can save significant amounts of money for your company. In fact, it may depend on your decision whether the import or production of a particular chemical substance remains profitable in the future. You can feel the pressure, yet you aren’t always able to provide your management the necessary information to make the best decisions. All this at a time when deadline 1st of September 2015, for the biocide active substance approval are coming closer and closer.
I have seen with many of my clients, that after they successfully complete the paper –based old biocid permits, they become confused at the new biocide active substance approval and at the new biocidal products authorisation when they need to use IUCLID and R4BP softwares.
I use IUCLID and REACH-IT sofwares since 2009 for REACH registration dossiers, that is why I can prepare a biocide dossier easily.
BIOCIDAL product dossier preparation;
Preparation of Biocidal Product (BP) Dossiers, that is quick, professional submission at a minimal cost!
Biocidal product authorisation is much more complex than we first thought. Without the help of a good consultant, or participating at biocide conferences on a regular basis it is a brave decision to complete a dossier.
What is the process of the biocidal product authorisation?
The main tasks by the deadline determined in the review program are the following: collect the information regarding the biocidal product, perform the tests, prepare theIUCLID dossier and send it to the European Chemical Agency (ECHA) through R4BP system.
The biocide dossier should be prepared through the IUCLID and R4BP programs. There are two kinds of dossiers, one which contains just a letter of access (LoA) and one which contains all the tests.
You should be in compliance with the most important rule:
As of 1 September 2015, a biocidal product shall not be made available on the market if the manufacturer or importer of the active substance(s) contained in the product, or where relevant, the importer of the biocidal product, is not included in this list of ECHA:
You need to know if your active substance supplier would be on the list of active substance suppliers by 1st of September 2015.
If your active substance supplier is not on the list, as of 1 September 2015, you cannot make available on the market a biocidal product containing this active substance.
It is good if you understand this procedure:
Active substance approval
The manufacturer or the importer of an active substance should submit to ECHA an application for approval of an active substance based on Article 6 through IUCLID and R4BP system by 1 September 2015, in order to be on the list of active substance suppliers.
After it, the Commission will evaluate the active substance through a review program by the following deadlines:
Priority
Existing active substances for product types
All draft CARs have to be submitted to ECHA by
The BPC have to submit all its opinions by
1st priority list
8, 14, 16, 18, 19, 21
31/12/2015
31/12/2016
2nd priority list
3, 4, 5
31/12/2016
31/12/2017
3rd priority list
1, 2
31/12/2018
31/12/2019
4th priority list
6, 13
31/12/2019
31/12/2020
5th priority list
7, 9, 10
31/12/2020
31/12/2021
6th priority list
11, 12, 15, 17, 22, 23
(new PT20 under BPR)
31/12/2022
31/06/2024
Biocidal product authorisation
If the review of an approval of an active substance is successful, than the active susbtance can stay on the list of active substance suppliers for 5, 7 or 10 years and in 3 years the manufacturer or the importer of a biocidal product should submit the biocidal product authorisation dossier.
The biocidal product authorisation should be submitted through IUCLID and R4BP program. According to Article 20 it contains the following
a dossier for the active substance (Annex II.) or
a Letter of Access (LOA) for the active substance and
a dossier for the biocidal product that contain the acitve substance (Annex III.) or
a Letter of Access (LOA) for the biocidal product that contain the acitve substance
The application should be submitted by the applicant or by its representative.
The biocidal product authorisation can be issued for a single biocidal product or for a biocidal product family.
Type of biocidal product authorisation:
Union authorisation (valid in all member states, but very expensive) or
National authorisation (valid in 1 member state)
The national authorisation can be extended for more member states:
Mutual recognition in sequence or ( Article 33)
Mutual recognition in parallel (Article 34)
What you need to know to complete the IUCLID dossier without assistance?
You must install on your PC the IUCLID program. You can download the program for free from www.iuclid.eu, but it is advisable to assign an IT specialist for this task.
You must learn to use the IUCLID program. It is not even that simple when doing it by yourself, since you must study a 2000 page instruction manual to be able to use the program.
If you decide not to spend one week to study the IUCLID program, you must participate in an IUCLID training.
If you have successfully acquired all skills to use IUCLID, I would like to raise your attention that preparing the dossier may theoretically be simple, but in practice it is not at all straightforwar
Do you find it easier and safer to ask a consultant to prepare your biocide Dossier?
You may enjoy the following advantages if you chose to have my company as your consultant to prepare your mini registration dossier:
We will describe the most simple method of preparing the dossier.
You do not need to correspond in English with the consortium members and with the authorites as we will do that for you.
We will revise the results of the analytical tests necessary for the substance identification, will inform you if they are not appropriate, and will organize new tests if necessary
You do not need to learn the IUCLID program (2 days of your life saved)
We will ensure 100% money back guarantee that your biocide dossier will successfully pass first. This means we will return your money if the submission does not pass for first trial.
What cost can I expect during active substance approval / biocidal product authorisation?
Fees payable to the European Chemical Agency (ECHA) are described in the 564/2013/EU regulation. SMEs can get a price redustion.
What shall I do if only my company manufacture or import an active substance and a biocidal product in EU?
Please calculate, will this product bring enough profit to submit the active substance and biocidal product dossiers?
If you decide to submit the active substance dossier, and the biocidal product authorisation, please contact me and ask a price quotation.
Requesting a price offer is free of charge, means no obligations for you and you will receive the offer in 2 days.
BIOCIDE active substance approval dossier service;
Preparation of Biocide active substance approval Dossiers, that is quick, professional registration at a minimal cost!
Biocide active substance approval is much more complex than we first thought. Without the help of a good consultant, or participating at biocide conferences on a regular basis it is a brave decision to complete a dossier.
What is the process of the active substance approval?
The main tasks in the approval process are as follows: collect the information regarding the active substance, perform the tests, prepare the IUCLID dossier and send it to the European Chemical Agency (ECHA) through R4BP ysytem.
The biocide dossier should be prepared through the IUCLID and R4BP programs. There are two kinds of dossiers, one which contains just a letter of access (LoA) and one which contains all the tests.
You should be in compliance with the most important rule:
As of 1 September 2015, a biocidal product shall not be made available on the market if the manufacturer or importer of the active substance(s) contained in the product, or where relevant, the importer of the biocidal product, is not included in this list of ECHA:
Since you produce biocide active substance, that is why your company should be on the list of active substance suppliers by 1st of September 2015.
If you are not on the list, as of 1 September 2015, you cannot produce the active susbtance, and nobody can make availbale on the market a biocidal product containing your active substance.
If you loved to be on the list of active substance supplier you should do the following tasks.
To submit an inquiry dossier through R4BP system to get the contact of those companies, who has tests, and who has letter of access (LoA). If you are able to get the contact without inquiry dossier, than it is a faster solution.
Ask the price of the Letter of Access (LoA) or
You do/collect the tests alone according to Annex II and III. It is a huge task, without a good biocide consultant it will be hard to complete.
You submit an active substance approval dossier
Active substance approval
The manufacturer or the importer of an active substance should submit to ECHA an application for approval of an active substance based on Article 6 through IUCLID and R4BP system by 1 September 2015, in order to be on the list of active substance suppliers.
It contains:
a dossier for the active substance (Annex II.) or
a Letter of Access (LOA) for the active substance and
a dossier for the biocidal product that contain the acitve substance (Annex III.) or
a Letter of Access (LOA) for the biocidal product that contain the acitve substance
Review program
The Commission will evaluate the active substance through a review program by the following deadlines:
Priority
Existing active substances for product types
All draft CARs have to be submitted to ECHA by
The BPC have to submit all its opinions by
1st priority list
8, 14, 16, 18, 19, 21
31/12/2015
31/12/2016
2nd priority list
3, 4, 5
31/12/2016
31/12/2017
3rd priority list
1, 2
31/12/2018
31/12/2019
4th priority list
6, 13
31/12/2019
31/12/2020
5th priority list
7, 9, 10
31/12/2020
31/12/2021
6th priority list
11, 12, 15, 17, 22, 23
(new PT20 under BPR)
31/12/2022
31/06/2024
If the review of an approval of an active substance is successful, than the active susbtance can stay on the list of active substance suppliers for 5, 7 or 10 years.
What you need to know to complete the IUCLID dossier without assistance?
You must install on your PC the IUCLID program. You can download the program for free from www.iuclid.eu, but it is advisable to assign an IT specialist for this task.
You must learn to use the IUCLID program. It is not even that simple when doing it by yourself, since you must study a 2000 page instruction manual to be able to use the program.
If you decide not to spend one week to study the IUCLID program, you must participate in an IUCLID training.
If you have successfully acquired all skills to use IUCLID, I would like to raise your attention that preparing the dossier may theoretically be simple, but in practice it is not at all straightforward.
Do you find it easier and safer to ask a consultant to prepare your biocide Dossier?
You may enjoy the following advantages if you chose to have my company as your consultant to prepare your mini registration dossier:
We will describe the most simple method of preparing the dossier
You do not need to correspond in English with the consortium members and with the authorites as we will do that for you.
We will revise the results of the analytical tests necessary for the substance identification, will inform you if they are not appropriate, and will organize new tests if necessary
You do not need to learn the IUCLID program (2 days of your life saved)
We will ensure 100% money back guarantee that your biocide dossier will successfully pass first. This means we will return your money if the submission does not pass for first trial.
What cost can I expect during active substance approval / biocidal product authorisation?
Fees payable to the European Chemical Agency (ECHA) are described in the 564/2013/EU regulation. SMEs can get a price redustion.
What shall I do if only my company manufacture or import this active substance in EU?
If you decide to submit the active substance dossier, and the biocidal product authorisation, please contact me and ask a price quotation.
Requesting a price offer is free of charge, means no obligations for you and you will receive the offer in 2 days.
IUCLID and R4BP training;
IUCLID training
I have seen with many of my clients, that after they successfully complete the paper –based old biocid permits, they become confused at the new biocide active substance approval and at the new biocidal products authorisation when they need to use IUCLID and R4BP softwares.
I use IUCLID and REACH-IT sofwares since 2009 for REACH registration dossiers, that is why I can prepare a biocide dossier easily.
IUCLID6 & R4BP training
I have completed the IUCLID training in January 2009 at the REACH Centrum in Brussels. Since then I have prepared more than 100 dossiers.
If you need IUCLID training at your company, or you have difficulties preparing the IUCLID dossier, I am glad to help you.
Training includes:
Installation of IUCLID
IUCLID website
Set up users and legal entity
Roles, special rights
Reference substances
TOC filling
Dossier creation in IUCLID
Dossier checking tool
Dossier submission in REACH-IT
Requesting a price offer is free of charge, means no obligations for you and you will receive the offer in 2 days.
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We will ensure your continous compliance with Biocide regulation so you can focus on your everyday job.
