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IUCLID5 for Biocide - Parking Lot Questions

Q. Is there a different fee for a product having a different name in another country? Is that a problem?
A. Additional fees are not applied provided company names are entered in the dossier at initial submission.

Fees for administrative change are requested from your national helpdesk as they may differ between member states.

Q. Difference between R4BP3 and R4BP2. Is the R4BP2 compatible with R4BP3?
A. R4BP3 is the upgraded communication portal that is based on R4BP2. ECHA is currently migrating Version 2 data to Version 3 and it is recommended that you ONLY use R4BP3.

You can access R4BP3 here

Q. What is the difference between reference substance and active substance?
A. A reference substance is part of an active substance dataset. The reference substance contains basic information on the molecule, such as CAS, EC number, molecular formula, molecular weight, structural formula, etc. A lot of reference substances are present in a database which can be imported in IUCLID.

Q. Is SPC a kind of CSR? 
A. An SPC is a document which presents the following topics: product information, authorized uses, hazard statements, directions for use and administrative information. This document should be made available to the public in the language of the countries where you want to apply for biocidal product authorization.

Q. Is IUCLID dossier required in case of application for inclusion in the list of active substance suppliers in case it is based on a LoA to a complete substance dossier?
A. If your application is base solely on a LoA to a complete substance dossier, an IUCLID dossier is not required.

Q. Does application for inclusion in the list of active substance suppliers under article 95 require data on substance identity (IUCLID5 sections 2.1, 2.8 and 2.9 of) and analytical profile of five batches (IUCLID5 sections 2.9 and 5.1) if it is based on a LoA to a complete substance dossier?
A. If your application is base solely on a LoA to a complete substance dossier, an IUCLID dossier is not required.

Q. I have one product for which I need an authorisation for non-professional consumers and one for professional consumers, do I have to create two dossiers on IUCLID?
A. No, this will be only one dossier, with off course a difference in risk assessment for professional and non-professional users.

Q. In case one of the co-formulant of the product is a mixture, how I should link it to the reference substance? Should I create a new reference substance?
A. No, all individual compounds of this mixture should be linked to a reference substance. For the mixture, a basic information mixture dataset can be made, which requires little input.

Q. How do we get ouselves included in the list of approved suppliers of active substances for a substance which is already under the review programme?
A. You have to apply for an Article 95 application, which also needs an IUCLID dossier if you do not have an LoA to the complete substance dossier.

Q. Sometimes the templates are very extensive and most of the fields do not apply. Could we leave any of the endpoints empty?
A. In general all sections correspond to the requirements in Annex II/III of the BPR, hence all endpoints present are required. Nonetheless, certain endpoints might be waived or read-across can be used if applicable. 

Q. Will the training include an explanation on the way(s) to submit a BP product family? I imagine there being various ways to do this most effectively.
A. Yes, all differences for a product family will be highlighted

Q. Co formulant should be added to the IUCLID dossier? If yes, where?
A. yes, all co-formulants should have a basic substance dataset if they are not a substance of concern. These datasets are then linked to the product in Section 2.3 where you specify the product composition.

Q. If in a mixture component of the product a substance is contained which is a substance of concern. Where do I point out that this particular substance is the SoC? Will this substance be then listed in the SPC? 
A. Yes, a SoC can be indicated in section 2.3 of your product dataset. Indeed, this information will be extracted to the SPC.

Q. Can you explain the status difference between IP and CBI?
A. For CBI: the data must not be provided to other companies or disseminated to the public. For IP: the data should only be provided to other companies when they are trusted (e.g. consortia or with letter of access); the data must not be disseminated to the public. 

Q. Can you give more information about parallel trade permit?
A. A parallel trade permit allows the holder of the permit to make a biocidal product available on the market in one Member State (Member State of introduction) if the biocidal product is authorised in another Member State (Member State of origin) and if the biocidal product is identical to a biocidal product already authorised in the Member State of introduction (the reference product).

If you want to obtain an authorisation for products of your customers under their own private label, you have to put all trade names of your customers in the original dossier and then your customers can put products on the market under your authorisation number. 

Q. For PT21, where Union Authorisation is not allowed, what is the tonnage (section 7.5) RMS, for all EU including MR countries?
A. The tonnage should be summed over all the countries where the product is available.

Q. Do we need to continuously update our likely tonnage on the market?
A. In case of the renewal of approved active substances, tonnage data should cover the last three years. For new substances not previously marketed, production plans covering three years after authorization should be provided. 

Q. Information section: is there a possibility to add remarks manually, for example to facilitate communication?
A. You can add annotations in the information section below every section. However we would not advise to put too much text there as this might not be read or might be misinterpreted if not destined for the authorities. 

Q. If mixtures are included in the final Biocidal Product, can non-hazardous ingredients of the mixture be added as "non-hazardous substance"? Assuming composition is confidential.
A. The composition of mixtures of co-formulants should be specified as much as possible. If the information is not available from the supplier, you should mention this in the remarks section. 

Q. How can non EU manufacturers protect their business information if the concept of OR does not exist, for example, if they do not want to disclose the formulation to the importer?
A. The Biocidal Products Regulation applies only to legal entities established in the European Union. Companies established outside of the EU are not bound by the obligations of the BPR, even if they export their products into the European Union. The responsibility for fulfilling the requirements of the BPR, such as the approval of active substances or the authorisation of biocidal products lies in principle with the importers established in the European Union. The importers in the EU may turn towards their non-EU suppliers and request information that they may need to fulfil their regulatory obligations. As a non-EU supplier, you can further support your customers (i.e. importers, established in the European Union) by providing sufficient information to fulfil the obligations of importers under the BPR. Hence, it is difficult not to disclose your information to the importer.

Q. Do we need to do the SPC for every single product, although if it is part of a product family?
A. Yes, an SPC should be produced for every product and one for the whole product family

Q. Mixture: basic information. When do we use this?
A. This can be used in case of a fragrance or when a co-formulant has a lot of constituents. However, it is still possible to fill in the complete composition in a basic substance dataset. You can chose where to put the information. 

Q. Where can I find the ECHA guidelines on “Confidentiality”
A. The guidelines are available in the ECHA website at http://echa.europa.eu/documents/10162/14938692/bsm_10_confidentiality_requests_en.pdf

 

 

Risk Assessment for Biocides - Parking Lot Questions

Q. Which is the best tool for Risk Assessment: EUSES or ECETOC TRA?
A. Assuming the question is referring to environmental assessment: EUSES because ECETOC TRA (for environment) was designed for REACH purposes. Despite ECETOC TRA is based on EUSES for the fate and exposure calculations, the emission estimation per product type is not included in ECETOC TRA.

Q. Is the Risk Assessment for Biocides different from Risk Assessment of Chemicals?
A. Yes and no. No, because the general risk assessment principles are the same and some parts/tools of the risk assessment are largely the same, e.g. the hazard assessment for environment, CONSEXPO. Yes, different especially for the exposure assessment and risk characterisation for human health.

Q. Are there any templates to write the Risk Assessment that is going to be imported in the section 13 of a product data set of IUCLID?
A. Yes.

Q. As per Biocidal Product Regulation are we required to submit Risk Assessment Report along with the dossier?
A. Yes, unless for some exceptions (e.g. substances on annex I).

Q. Do you present Risk of Derm, Ecetoc TRA, etc during the courses?
A. ECETOC TRA: no because not specifically designed for biocides. Risk of Derm: yes is shortly considered but no hands-on exercises

 

CLP for Mixtures - Parking Lot Questions

Q. How to classify your substance as STOT-SE Cat.3.
A. The criteria for classifying substances as Category 3 for respiratory tract irritation are:

(a) respiratory irritant effects (characterized by localized redness, oedema, pruritis and/or pain) that impair function with symptoms such as cough, pain, choking, and breathing difficulties are included. This evaluation will be based primarily on human data.

(b) subjective human observations could be supported by objective measurements of clear respiratory tract irritation (RTI) (such as electrophysiological responses, biomarkers of inflammation in nasal or bronchoalveolar lavage fluids).

(c) the symptoms observed in humans shall also be typical of those that would be produced in the exposed population rather than being an isolated idiosyncratic reaction or response triggered only in individuals with hypersensitive airways. Ambiguous reports simply of “irritation” shall be excluded as this term is commonly used to describe a wide range of sensations including those such as smell, unpleasant taste, a tickling sensation, and dryness, which are outside the scope of classification for respiratory irritation.

(d) there are currently no validated animal tests that deal specifically with RTI, however, useful information may be obtained from the single and repeated inhalation toxicity tests. For example, animal studies may provide useful information in terms of clinical signs of toxicity (dyspnoea, rhinitis etc) and histopathology (e.g. hyperemia, edema, minimal inflammation, thickened mucous layer) which are reversible and may be reflective of the characteristic clinical symptoms described above. Such animal studies can be used as part of weight of evidence evaluation.

(e) this special classification would occur only when more severe organ effects including in the respiratory system are not observed.

Human evidence for RTI often comes from occupational case reports where exposure is associated with signs of RTI. Such reports should be interpreted carefully using expert judgement to ensure that they provide reliable information. For instance, there should be a clear relationship between exposure and the development of signs of RTI, with RTI appearing relatively soon after the start of exposure. A solid substance which causes RTI due to physical/mechanical irritation when inhaled as a dust should not be classified. For more details on RTI, see the Guidance on IR/CSA Chapter R7a.7.2.1, and example n° 3 for sulfur dioxide.

The criteria for classifying substances as Category 3 for narcotic effects are:

a) central nervous system depression including narcotic effects in humans such as drowsiness, narcosis, reduced alertness, loss of reflexes, lack of coordination, and vertigo are included. These effects can also be manifested as severe headache or nausea, and can lead to reduced judgment, dizziness, irritability, fatigue, impaired memory function, deficits in perception and coordination, reaction time, or sleepiness.

b) narcotic effects observed in animal studies may include lethargy, lack of coordination, loss of righting reflex, and ataxia. If these effects are not transient in nature, then they shall be considered to support classification for Category 1 or 2 specific target organ toxicity single exposure.

Narcotic effects may range from slight dizziness to deep unconsciousness and may be caused by several mechanisms:

  • pharmaceutical drugs (designed effect; often receptor-mediated; effective dose usually low; patient under professional observation; limited importance for industrial chemicals and their safety assessment.)
  • unspecific effects of many organic industrial chemicals on CNS-membranes at high dose levels (often solvent vapours, ≥ 6000 ppm in respired air volume). Such effects can be expected at high exposure levels due to otherwise low toxicity.
  • organic chemicals with similarities to and interference with CNS-transmitters; often metabolic transformation necessary; certain solvents, e.g. butandiol, butyrolactone, methoxyethanol; medium levels of effective dose. Children may be considerably more susceptible than adults.
  • chemicals with high specific CNS toxicity; narcotic effects usually close to near-lethal doses (example: H2S).

Narcotic effects are usually readily reversible on cessation of exposure with no permanent damage or changes.

Human evidence relating to narcosis should be evaluated carefully. Often the reporting of clinical signs is relatively subjective and reports of effects such as severe headache and dizziness should be interpreted carefully to judge if they provide robust evidence of narcosis. Where relevant human data do not mirror realistic exposure conditions, for instance in case reports from accidental over-exposure situations, supportive information may be needed to corroborate the observed effects. A single case report from accidental or deliberate exposure (i.e. abuse) is unlikely to provide sufficiently robust evidence to support classification without other evidence.

AND

Category 3

There are no similar guidance values for Category 3. Therefore, if the study shows clear evidence for narcotic effects or respiratory tract irritation at any dose level then this could support classification with Category 3.

In evaluating inhalation studies a differentiation of respiratory tract effects and systemic effects should always be attempted. In addition, the region in the respiratory tract and the qualitative nature of observed effects is pivotal. Often, the lesions observed are representing stages of a reaction pattern leading to severe and irreversible functional and structural alterations. Therefore reversibility of effects is a significant discriminator.

 

REACH Awareness Bootcamp - Parking Lot Questions

Q. Where can I find the ECHA guidelines on “Sameness”
A. The guidelines are available in the ECHA website at http://echa.europa.eu/web/guest/regulations/reach/substance-identity

Q. What is temporal market?
A. Temporal market can refer to a seasonal market. Specifically it is the time period that underlies the market analysis eg. for certain products there may be limited production times.

Case-law before the ECJ: Decision that it is the whole agricultural year in relation to bananas since these ripened throughout the year (United Brands,1993).

Factsheet, European Commission, 2015: http://trade.ec.europa.eu/doclib/docs/2015/february/tradoc_153121.pdf

Position paper from the European Commission, 2014: http://trade.ec.europa.eu/doclib/docs/2014/may/tradoc_152468.pdf

Q. Price of LoA?
A. Price of LoA that is excessive to the registrant’s requirements in terms of need for data for its tonnage band. See A°30.1 para.2, last sentence on Sharing of data involving tests – “Registrants are only required to share in the costs of information that they are required to submit to satisfy their registration requirements”.