V okviru avtorizacijskega postopka družine biocidnih proizvodov je potrebno predati tudi oceno endokrinih lastnosti snovi v družini biocidnih proizvodov skladno z znanstvenimi merili za ugotavljanje lastnosti endokrinih motilcev.
REACH registration – Key to entering the European market
REACH Regulation (EC) 1907/2006 requires all manufacturers or importers who manufacture or import a chemical in quantities of one tonne or more per year to register their substances. Companies face many questions they are unable to solve by themselves due to the complexity of REACH.
In order to facilitate your decision to proceed, we will prepare, free of charge, a portfolio overview and budget for registration, including the specification of all costs related to registration.
Portfolio overview
In the first step, together with you we will review your portfolio of chemicals and determine the substances that you wish to register.
Preparing the budget
The price of registration highly depends on different items, so we will prepare a budget for you free of charge to facilitate your decision to continue with the process.
Registration
On your behalf, we will oversee the process until final registration, which gives you the right to market the substance on the EU market.
GET IN TOUCH
Tel. +386 59016985
email: info@bisafe.si
Portfolio overview
In the first step, together with you we will review your portfolio of chemicals and determine the substances that you wish to register.
Substances
Substances should be precisely identified and their EC number determined. Inappropriate classification may lead to invalid registration. Therefore, this step requires close cooperation, because the identity of the substance often depends not only on analytical results but also on the manufacturing process.
Mixtures
Mixtures (e.g. paints) contain different substances that are dealt with differently under REACH. Through a diligent overview of your range of products, we will help determine substances that need to be registered with respect to the content in each mixture and the quantity of the mixture introduced.
Preparing registration budget
How much does registration cost?
The price of registration needs to be determined for each substance separately, since it comprises several elements.
Letter of access
The price of obtaining a letter of access (LoA) is determined by the lead registrant for each substance separately with respect to the number of studies that should be conducted for substance registration and the number of co-registrants in the registration.
Fee (depending on the company size and quantities)
The fee that needs to be paid to the European Chemicals Agency depends on the size of the company applying for registration and the quantity of the imported or manufactured substance. Fees are set out by the regulation.
Laboratory analysis
During registration, the analytical results must be submitted allowing for the identification and composition specification of the substance, including all impurities. This usually includes chromatographic methods or elemental analyses and spectroscopic methods.
Documentation preparation
The price for preparing documentation depends on the procedures required for registration.
GET IN TOUCH
Tel. +386 59016985
email: info@bisafe.si
Registration
Pre-registration preliminary inquiry
In accordance with Article 26 of REACH, companies that did not register their substances by 1 June 2017 must perform a pre-registration inquiry with ECHA.
During the inquiry, we perform the following activities on your behalf:
Substance registration – joint submission
Most registrations are made according to the joint submission procedure. You buy the letter of access (LoA) from the lead registrant (company which first registered the substance), which allows you to join their registration.
In this case, you only need to prepare your individual part of the dossier to prove that the substance you manufacture or import is identical to the substance for which data were submitted by the lead registrant.
During the process of preparing the individual part of the dossier, we perform the following activities for you:
Substance registration – individual dossier
If no one in the EU has registered the same substance you manufacture or import, you must prepare a complete dossier with all the required studies. The amount of information required depends on the quantity of the manufactured or imported substance, on which also depends the final price for the dossier
During the process of preparing the individual part of the dossier, we perform the following activities for you:
GET IN TOUCH
Tel. +386 59016985
email: info@bisafe.si
OTHER SERVICES
Each biocidal product requires a permit before it is supplied to the customer.
Before placing a cosmetic product on the market, a manufacturer or importer must prepare a product information file (PIF) of the cosmetic product and notify it in the Cosmetic Products Notification Portal (CPNP).
