Application for the modified reassessment of a hazardous substance Under Section 63A of the Hazardous Substances and New Organisms Act 1996 Chemical Review 2012 – 2014 A modified reassessment of a range of substances for which new information was obtained in the period 2012 - 2014 Application number: APP202482 Applicant: Chief Executive, Environmental Protection Authority www.epa.govt.nz Chemical Review 2012 – 2014 (APP202482) 2 Applicant’s details Name: Rob Forlong, Chief Executive Address: EPA, Level 10, 215 Lambton Quay, Private Bag 63002, Wellington 6140 Phone: 04 474 5403 Fax: 04 914 0433 Email: [email protected] Applicant’s contact person Name: Asela Atapattu Address: EPA, Level 10, 215 Lambton Quay, Private Bag 63002, Wellington 6140 Phone: 04 474 5463 Fax: 04 914 0433 Email: [email protected] Signature of Applicant 3 June 2015 Rob Forlong Date Chief Executive Environmental Protection Authority Chemical Review 2012 – 2014 (APP202482) 3 Background The Environmental Protection Authority regularly receives new information from stakeholders regarding the classifications and controls of substances. EPA staff also note where changes to approvals are needed. Where those changes are not minor or technical, these changes require a reassessment or a modified reassessment of the approval of the substance under the HSNO Act 1996 (“the Act”) The Chemical Review is intended as a means of making changes to a number of approvals at once, taking into account the new information available to the EPA. This is undertaken as a modified reassessment under section 63A of the Act. This application makes recommendations to change some or all of the following aspects of the approvals in this application: - The approval name of the substance - The hazard classification(s) applied to the substance - The controls applied to the substance The controls changes proposed are largely as a result of changes to the hazard classifications of the substances in this application. These consist of changes to the default controls, as well as changes in variations of controls, to fit current practise based on recent approvals. It is important to note that the proposals of EPA staff may or may not be supported by the decision- making committee for this application. The decision-making committee can choose to accept, reject or modify the recommendations. For this reason the EPA encourages submissions on the proposed changes. Additionally, note that a modified reassessment under section 63A of the Act may not revoke an approval given to a hazardous substance under this Act to import or manufacture the substance (section 63A (2)(b) of the Act). Grounds for reassessment Grounds for reassessment have been obtained as part of the Grounds application, APP201983. A decision making committee determined that there were grounds for the reassessment of the substances listed in the application for grounds for reassessment. Substances in application The substances in this application are identified in Appendices 1-4. These are grouped as follows: Appendix 1: Substances for which there is new information. Appendix 2: Substances where changes are required as a result of the reassessment of Organophosphate and Carbamate pesticides in plant protection products. Chemical Review 2012 – 2014 (APP202482) 4 Appendix 3: Substances where changes are required as a result of the Antifouling Paints Reassessment. Appendix 4: Confidential substances, where a component of a substance appears in Appendix 1, 2 or 3, but the presence of the component in the substance is confidential. These appendices note the name of the substance, the approval number, the current and proposed classifications, and the proposed changes to the controls. For Appendices 1, 2, and 3, an explanation of the reasons for changes are given. For Appendix 4, this explanation is only present in the confidential appendix to this application. This section discusses the changes to substances likely to be of particular importance to submitters or where the EPA seeks further information. Substances for which there is new information Included in this section are a range of single chemical approvals and approvals for mixtures. Where changes recommended for a substance affect mixtures containing that substance, changes proposed to affected mixtures are also detailed. Changes that may be of particular note to submitters are: Benzene, dimethyl-, mixed isomers, ≥ 25% in a non hazardous diluent This approval for a dilution of mixed isomers of xylene is changed to add a 3.1C flammable liquid classification. While this represents a significant increase in hazard classification and accordingly results in a number of additional controls to manage risks associated with the flammability hazard, the resulting classification and controls are in line with other approvals for xylene. Camphor Camphor currently has two approvals – HSR007255 for camphor and HSR001270 which has the systematic name ‘Bicyclo[2.2.1]heptan-2-one, 1,7,7-trimethyl’. This situation arose due to HSR007255 being an approval for an obsolete CAS number for camphor. HSR007255 does not have several classifications that were applied to HSR001270, and these are proposed to be added to HSR007255, and the controls of HSR007255 changed to match HSR001270. While this change does not affect any approved substances containing camphor, there may be substances assigned to Group Standard approvals that have used incorrect hazard classifications based on the classification of HSR007255 rather than HSR001270. Bifenthrin A review undertaken by the European Food Safety Authority (EFSA) and information from the European Chemicals Agency (ECHA) has been used to review the classification of bifenthrin. This revised classification has been used in classifying several recent approved substances containing bifenthrin. Additionally, a number of variations to the default controls have been applied to those recent approvals. This application updates the classification and controls of other bifenthrin approvals to align them with the recent approved substances. Chemical Review 2012 – 2014 (APP202482) 5 Copper (II) carbonate hydroxide The acute oral, dermal and inhalation toxicity classifications of 6.1C are proposed to be downgraded for copper (II) carbonate hydroxides, and the 6.3A and 6.5B classifications removed. As a result the acute toxicity classification of a number of substances containing this component, largely timber treatments, is proposed to be downgraded to 6.1D or lower. As a result, many controls usually imposed for 6.1C and higher acute toxicity substances, such as approved handler and tracking requirements, are proposed to be varied and removed. Alpha-bisabolol The 6.1B acute oral toxicity classification and the 9.3A vertebrate ecotoxicity classification are proposed to be removed from alpha-bisabolol, and a 9.1B classification is proposed to be added. This results in substantially reduced controls for the dilution approval HSR007299, and this approval also is proposed to be split into two approvals, based on a mixture rules calculation for the new 9.1 classification. Ethanol, 2-(2-ethoxyethoxy) – synonyms ethoxydiglycol, carbitol and diethylene glycol monoethyl ether The EPA has received new test data indicating that the closed cup flashpoint test data for ethoxydiglycol is 94 ºC, just above the threshold for classification as a flammable liquid (3.1D). As a consequence, the flammable classification should no longer apply to a range of approved substances containing this solvent and no other flammable components. However, the EPA was provided product flashpoint data for some of these approvals that indicates a flammable liquid classification is required. In some cases this is despite the approved substance now containing no components that have a flammable classification. Some approvals are proposed to be split into a flammable approval and a non-flammable approval, with appropriate controls applied to each approval. Approvals that are already not classified as flammable (ie. where no changes are required), are not listed in this application. Companies that use ethoxydiglycol in their products are encouraged to determine whether the change in the flammability classification of ethoxydiglycol affects the classification of their products. The EPA encourages submitters to provide further information to the EPA regarding the proposed changes to approvals. Glutaraldehyde The acute inhalation toxicity classification of glutaraldehyde is proposed to be reduced from 6.1A to 6.1B. This results in a lower classification for the approvals for dilutions of glutaraldehyde. Companies are encouraged to determine how the new classification may affect the classification of products containing glutaraldehyde that use a group standard approval. Chemical Review 2012 – 2014 (APP202482) 6 Methylene diphenyl diisocyanate and Methylene 4,4’-diphenyl diisocyanate (MDI) The EPA has approvals for both generic MDI and the 4,4’-isomer of MDI, as well as approvals for dilutions of each of these in a non-hazardous diluent. This application recommends changes to the dilution approvals to make them consistent with the classifications applied to the pure substance approvals. Additionally, based on information from the European Union REACH registration (Registration, Evaluation, Authorisation and restriction of Chemicals) a 6.7B suspected human carcinogen classification is recommended to be applied to each of these approvals. Phenyl acetate A flammable liquid classification of 3.1D is proposed to