Regulation (EU) n°528/2012 concerning the making available on the market and use of biocidal products
Evaluation of active substances
Assessment Report
Bromoacetic acid
Product-type 4
(Food and feed area disinfectants)
17 May 2013
RMS: Spain
RMS: Spain / Bromoacetic acid (PT4) / 12 July 2013 /Bromoacetic acid (PT4)
Assessment report
Finalised in the Standing Committee on Biocidal Products at its meeting on 12 July 2013
CONTENTS
1. STATEMENT OF SUBJECT MATTER AND PURPOSE 4
1.1. Principle of evaluation 4
1.2. Purpose of the assessment 4
1.3. Procedure followed 4
2. OVERALL SUMMARY AND CONCLUSIONS 7
2.1. Presentation of the Active Substance 7
2.1.1. Identity, Physico-Chemical Properties & Methods of Analysis 7
2.1.2. Intended Uses and Efficacy 8
2.1.3. Classification and Labelling 8
2.2. Summary of the Risk Assessment 10
2.2.1. Human Health Risk Assessment 10
2.2.1.1. Hazard identification 10
2.2.1.2. Effects assessment 13
2.2.1.3. Exposure assessment and Risk characterisation 14
2.2.2. Environmental Risk Assessment 16
2.2.2.1. Fate and distribution in the environment 17
2.2.2.2. Effects assessment 18
2.2.2.4. Exposure assessment 24
2.2.2.5. Risk characterisation 31
2.2.3. List of endpoints 35
3. PROPOSED DECISION 36
3.1. Background to the proposed decision 36
3.2. Proposed decision 37
3.3. Elements to be taken into account when authorising products 38
3.4. Requirement for further information 38
3.5. Updating this Assessment Report 38
Appendix I: List of endpoints 39
Chapter 1: Identity, Physical and Chemical Properties, Classification and Labelling 39
Chapter 2: Methods of Analysis 42
Chapter 3: Impact on Human Health 43
Chapter 4: Fate and Behaviour in the Environment 45
Chapter 5: Effects on Non-target Species 47
Chapter 6: Other End Points 49
Appendix II: List of Intended Uses 50
Appendix III: List of studies 51
1. STATEMENT OF SUBJECT MATTER AND PURPOSE
1.1. Principle of evaluation
This assessment report has been established as a result of the evaluation of bromoacetic acid product-type 4 (Food and feed area disinfectants), carried out in the context of the work programme for the review of existing active substances provided for in Article 16(2) of Directive 98/8/EC concerning the placing of biocidal products on the market[1], with the original view to the possible inclusion of this substance into Annex I or IA to that Directive.
The evaluation has therefore been conducted in the view to determine whether it may be expected, in light of the common principles laid down in Annex VI to Directive 98/8/EC, that there are products in product-type 4 containing bromoacetic acid that will fulfil the requirements laid down in Article 5(1) b), c) and d) of that Directive. Those requirements and common principles are very similar to those laid down in Article 19(1), (2) and (5) and Annex VI of Regulation (EU) No 528/2012. At the time of finalisation of this assessment report, there was no indication that the conclusions regarding compliance with Directive 98/8/EC would not be valid for the purpose of establishing compliance with the requirements of Regulation (EU) No 528/2012.
1.2. Purpose of the assessment
The aim of the assessment report is to support a decision on the approval of Bromoacetic acid for product-type 4, and should it be approved, to facilitate the authorisation of individual biocidal products in product-type 4 that contain bromoacetic acid. In the evaluation of applications for product-authorisation, the provisions of Regulation (EU) No 528/2012 shall be applied, in particular the provisions of Chapter IV, as well as the common principles laid down in Annex VI.
The conclusions of this report were reached within the framework of the uses that were proposed and supported by the applicant (see Appendix II). Extension of the use pattern beyond those described will require an evaluation at product authorisation level in order to establish whether the proposed extensions of use will satisfy the requirements of Regulation (EU) No 528/2012.
For the implementation of the common principles of Annex VI, the content and conclusions of this assessment report shall be taken into account.
However, where conclusions of this assessment report are based on data protected under the provisions of Regulation (EU) No 528/2012, such conclusions may not be used to the benefit of another applicant, unless access to these data has been granted.
1.3. Procedure followed
This assessment report has been established as a result of the evaluation of Bromoacetic acid as product-type 4 (Food and feed area disinfectants), carried out in the context of the work programme for the review of existing active substances provided for in Article 16(2) of Directive 98/8/EC concerning the placing of biocidal products on the market, with a view to the possible inclusion of this substance into Annex I or IA to the Directive.
Bromoacetic acid (CAS no. 79-08-3) was notified as an existing active substance, by Albemarle Europe SPRL and Sopura S.A., hereafter referred to as the applicant, in product-type 4.
Regulation (EC) No 1451/2007 of 4 December 2007[2], which has repealed and replaced Commission Regulation (EC) No 2032/2003 of 4 November 2003[3], lays down the detailed rules for the evaluation of dossiers and for the decision-making process in order to include or not an existing active substance into Annex I or IA to the Directive.
In accordance with the provisions of Article 5(2) of Regulation (EC) No 2032/2003, Spain was designated as Rapporteur Member State to carry out the assessment on the basis of the dossier submitted by the applicant. The deadline for submission of a complete dossier for Bromoacetic acid as an active substance in Product Type 4 was 31.07.2007, in accordance with Annex V of Regulation (EC) No 2032/2003.
On 27th July 2007, Spanish competent authorities received a dossier from the applicant. The Rapporteur Member State accepted the dossier as complete for the purpose of the evaluation on 31st January 2008.
On 22nd January 2011, the Rapporteur Member State submitted, in accordance with the provisions of Article 14(4) and (6) of Regulation (EC) No 1451/2007, to the Commission and the applicant a copy of the evaluation report, hereafter referred to as the competent authority report. The Commission made the report available to all Member States by electronic means on 1st March. The competent authority report included a recommendation for the inclusion of Bromoacetic acid in Annex I to the Directive for PT 4.
In accordance with Article 16 of Regulation (EC) No 1451/2007, the Commission made the competent authority report publicly available by electronic means on [date]. This report did not include such information that was to be treated as confidential in accordance with Article 19 of Directive 98/8/EC.
In order to review the competent authority report and the comments received on it, consultations of technical experts from all Member States (peer review) were organised by the Commission. Revisions agreed upon were presented at technical and competent authority meetings and the competent authority report was amended accordingly.
In accordance with Article 15(4) of Regulation (EC) No 1451/2007, the present assessment report contains the conclusions of the Standing Committee on Biocidal Products, as finalised during its meeting held on 12 July 2013.
58
RMS: Spain / Bromoacetic acid (PT4) / Assessment report /2. OVERALL SUMMARY AND CONCLUSIONS
2.1. Presentation of the Active Substance
2.1.1. Identity, Physico-Chemical Properties & Methods of Analysis
CAS-No. / 79-08-3EINECS-No. / 201-175-8
Other No. (CIPAC, ELINCS / -
IUPAC Name / 2-bromo-ethanoic acid
Common name, synonym / Bromoacetic acid
Molecular formula / C2H3Br O2
Structural formula /
Molecular weight (g/mol) / 138.95 g/mol
Purity of a.s. (% w/w) / 95.25 (94.6 – 96.12) % w/w (dry weight basis)81.46 (81.1 – 81.9.) % w/w (wet weight basis)
Impurities and additives: / Information on the impurities and additives in the technical grade active substance is confidential and is presented in the confidential attachment
The purified Bromoacetic acid is a solid crystalline and colourless, but Bromoacetic acid as manufactured is an aqueous solution containing 95.25 (94.6 – 96.12) % w/w (dry weight basis)81.46 (81.1 – 81.9.) % w/w (wet weight basis) according to five batch analysis At 41°C starting melting and it is completely melted without concurrent decomposition at 46°C The water solubility resulted higher than 1 kg/L at 20°C for the pH range of 1.09–5.69. The partition coefficient of Bromoacetic acid also varies with pH and temperature. The vapour pressure (13.5 Pa at 20°C) and Henry’s Law constant is low. Bromoacetic acid is not highly flammable and has no explosive and oxidising properties.
Analysis of active substance as manufactured: The active substance and its identity can be determined by NMR-, IR- and MS-spectroscopy. For determination in mixtures the GLC-chromatography method described below (1.4.2) is recommended. The active substance is not metabolized to toxicological relevant residues, which require a specific analytical method.
Formulation analysis: The active substance and the identity of the active substance in the product are determined by HPLC analysis. No enrichment or cleanup is necessary. The method is calibrated for the range from 624 mg/L to 1029 mg/L for Bromoacetic acid; linearity gives a correlation coefficient of r2 = 0.9997; recovery rate is >100.0 % and the relative standard deviation is 0.32%; the limit of detection is ca. 10 mg/L.
Residue analysis: For the detection of Bromoacetic acid in beer, the typical application as the biocidal product, an HPLC method has been validated with a detection limit of 0.1µg/L. In addition reference methods for the detection of Bromoacetic acid in water have been developed. An example is included in the table 1.4.
The application of the SEPTACID S or SEPTACID S PS biocidal products will cause residues in food below the limit of concern provided that appropriate post-use water rinse measures are followed.
2.1.2. Intended Uses and Efficacy
Bromoacetic acid as used for the formulation of biocidal products is an aqueous solution containing 80% (w/w) a.s. It has to be stored separately from other material.
The biocidal products (SEPTACID S / S PS) are a corrosive solution and must be handled wearing PPE and they are only intended for use in cleaning in place (CIP) systems. The representative products SEPTACID S and SEPTACID S PS contain 8% w/w and 4% w/w Bromoacetic acid, respectively are intended for the disinfection of food processing installations i.e. breweries by means of CIP (cleaning in place) of such installations circulating the biocidal product to clean and disinfect the apparatuses. These end-products are intended for professional users only.
The recommended concentration of the biocidal product SEPTACID S is 1% (v/v) maximum corresponding to 0.13% (w/v) a.s. The bactericidal activity of the biocidal product SEPTACID S is proved at 1% but the fungicidal activity at 1% does not fulfill under obligatory conditions. On the contrary, this product tested at 1% demonstrated fungicidal activity under additional conditions. The recommendation for the concentration of the biocidal product SEPTACID S PS in the treatment solution is 2% (v/v) maximum corresponding to 0.12% (w/v) a.s. The bactericidal and fungicidal activities of the biocidal product SEPTACIS S PS is proved at 5%.
Bromoacetic acid is a disinfectant for the use in food and feed area. Bromoacetic acid is a bactericide and fungicide with high efficacy against microorganisms known for their potential of beer spoiling effects, e.g. bacteria Escherichia coli, Pseudomonas aeruginosa, Staphylococcus aureus, Enterococcus hirae and fungi Candida albicans, Aspergillus niger.
In addition, in order to facilitate the work of Member States in granting or reviewing authorisations, and to apply adequately the provisions of Article 5(1) of Directive 98/8/EC and the common principles laid down in Annex VI of that Directive, the intended uses of the substance, as identified during the evaluation process, are listed in Appendix II.
2.1.3. Classification and Labelling
Active substance:
- Classification according to Annex I of Council Directive 67/548/EEC
Current classification of a.s.
Classification / as in Directive 67/548/EECClass of danger / T (Toxic), C (Corrosive), N (Dangerous for the environment)
R phrases / R23/24/25: Toxic by inhalation, in contact with skin and if swallowed.
R35: Causes severe burns.
R43: May cause sensitisation by skin contact
R50: Very toxic to aquatic organisms
S phrases / S1/2, S26, S36/37/39, S45, S61
Bromoacetic acid is also classified as R41 but according to Dir. 67/548/EEC when a substance or preparation is classified as corrosive and assigned R34 or R35, the risk of severe damage to eyes is considered implicit and R41 is not included in the label
We propose no change the classification and labelling.
- Classification according to Regulation (EC) No 1272/2008 on classification, labelling and packaging (CLP) of substances and mixtures
Current classification of a.s.
Hazard Class and Category Code(s) / Hazard Statement Code(s)Acute Tox. 3
Acute Tox. 3
Acute Tox. 3
Skin Corr. 1A
Skin Sens. 1
Aquatic acute 1 / H331: Toxic if inhaled
H311: Toxic in contact with skin
H301: Toxic if swallowed
H314: Causes severe skin burns and eye damage
H317: May cause an allergic skin reaction
H400: Very toxic to aquatic life. / Pictogram, Signal Word Code(s)
GHS06
GHS05
GHS09
Dgr
Regarding the environment, Bromoacetic acid, the substance is toxic for algae with L(E)C50 less than 1 mg/l and higher than 0.1 mg/l. It is a ready degradable substance and totally soluble in water.
Product Septacid S:
- Classification according to Annex I of Council Directive 67/548/EEC
Current classification of b.p.
Classification / as in Directive 67/548/EECClass of danger / C (Corrosive)
R phrases / R20/21/22, R35
S phrases / S20/21, S26, S30, S36/37/39, S45
Proposed classification
Classification / as in Directive 67/548/EECClass of danger / T+ (Very toxic); C (Corrosive)
R phrases / R26, R21/22, R35, R43
S phrases / S20/21, S26, S30, S36/37/39, S45
Not classified for the environment. The proposals are based on study results presented in the dossier and the composition of the products.
- Proposed classification according to the Regulation (EC) No 1272/2008 of the European Parliament and of the Council and the Globally Harmonised System of Classification and Labelling of Chemicals (hereinafter referred to as "the GHS"):
Classification / as in Regulation (EC) No 1272/2008Class of danger / Acute Toxicity Cat. 1 H330; Acute Toxicity Cat. 4 H302; Acute Toxicity Cat. 3 H311; Skin Corrosion Cat. 1A H314; Skin Sensitizer Cat. 1 H317; EUH071
Product Septacid S PS: