Global Regulatory Update for July 2015
China Publishes Revised New Chemical Notification And Registration Guidance For Public Comment: After over a year of review and revision, on June 25, 2015, the Chinese Ministry of Environmental Protection Solid Waste and Chemical Management Center (MEP-SCC) published the “Guidance for New Chemical Substance Notification and Registration (Draft)” (Guidance) for public comment. The deadline to submit comments to MEP-SCC regarding the Guidance is July 31, 2015. Comments should be submitted to MEP-SCC via e-mail (email@example.com). MEP-SCC held a meeting to explain the Guidance on the afternoon of July 9, 2015, at MEP-SCC in Beijing. This revised Guidance would simplify the registration formality and adopt a weight of evidence approach for certain data requirements. The European Union’s (EU) Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) approach on the carcinogenicity data requirement would, for example, be adopted. The carcinogenicity test decision for new chemical substances manufactured and/or imported at quantities above 1,000 tonnes per year would be on a case-by-case basis. Human exposure and the inherent potential of the substance to induce genotoxicity and/or to induce hyperplasia and/or pre-neoplastic lesions in repeated dose toxicity studies should be evaluated. It should be noted that a daphnia reproduction test or a bioconcentration test would be conducted in China for Level 2 regular registration because the fish 14-day prolonged toxicity test would not be required. More information on the key provisions in the revised guidance is available in The Acta Group’s (Acta®) July 1, 2015, memorandum.
ECHA Adds Two SVHCs To Candidate List: The European Chemicals Agency (ECHA) announced on June 15, 2015, that it added the following substance of very high concern (SVHCs) to the Candidate List:
- A series of mixed alkyl diesters due to their reproductive toxicity properties where they contain 0.3 percent or more dihexyl phthalate. These substances are used as plasticizers and lubricants, including use in adhesives, coatings, building material, cable compounding, polymer foils, polyvinyl chloride (PVC) compounds, and artist supplies (e.g., modeling clay and finger paints); and
- A group entry with very persistent and very bioaccumulative (vPvB) properties. This group of substances covers for example, the product with the trade name “karanal.” Public information sources indicate that the main use of karanal is as a fragrance ingredient.
ECHA states that it took the decision to include these two substances on the Candidate List based on proposals by Sweden and the Netherlands respectively, following the SVHC identification process with involvement of the Member State Committee.
EFSA Proposes “Uncertainty Toolbox” For Scientific Assessments: The European Food Safety Authority (EFSA) announced on June 18, 2015, that it is soliciting comment on its draft guidance on uncertainty in scientific assessment. EFSA states that the consultation is aimed at the international scientific community, European and national risk assessors, risk communicators, and risk managers, as well as EFSA’s stakeholders. According to EFSA, its Scientific Committee developed the draft guidance “to offer a tool-box of methodologies — both quantitative and qualitative — for analysing scientific uncertainties in all its scientific assessments.” The approach is intended to be sufficiently flexible to adapt to the circumstances of each assessment. Following feedback from the public consultation and further revision of the draft, each EFSA Scientific Panel will test the guidance document during a pilot phase. EFSA states that its experts will use the results to refine further the guidance document before it is issued in final. In the meantime, EFSA will also carry out research on the best methods for communicating scientific uncertainties to various target audiences. Once approved, the guidance will be applied to all EFSA’s scientific assessments. Comments are due September 10, 2015.
ECHA Urges Companies To Get Ready For 2018 Registration Deadline: ECHA issued a June 23, 2015, press release urging companies to prepare for the May 31, 2018, registration deadline. By that date, all chemical substances produced or imported in the European Economic Area (EEA) between one and 100 tonnes a year must be registered with ECHA. According to ECHA, the first phase of REACH registration 2018 “is about knowing your portfolio and starting preparations now.” ECHA recommends companies analyze the sales and production volumes of their substance portfolio, review their obligations under REACH, and make a plan on how to manage their registrations for the last deadline. ECHA, the Member States, and industry organizations are available to help potential registrants. ECHA states that the new support web section on its website will help them with their registration tasks. ECHA will provide more practical support phase-by-phase over the coming years. The REACH 2018 pages work as a gateway to all relevant information.
ECHA Shortlists Approximately 200 Substances For Possible Regulatory Action: On June 25, 2015, ECHA announced that it shortlisted approximately 200 substances from REACH registrations for further scrutiny by Member State competent authorities. The competent authorities will carry out a manual examination of the dossiers to determine whether there is a need for regulatory action, such as compliance checks, substance evaluations, harmonized classifications and labeling, authorizations, or restrictions. According to ECHA, the shortlisted substances are registered by 800 companies in around 1,300 registration dossiers. The selection is based on an automated screening focusing on substances with potential carcinogenic, mutagenic, or toxic to reproduction (CMR), persistent, bioaccumulative, and toxic (PBT), endocrine disrupting, or sensitizing properties. Substances are then further prioritized based on uses likely to lead to exposure to humans or release to the environment. ECHA states that affected companies will soon receive a letter informing them of the ongoing examination of their registrations. Companies are invited to update their dossiers to address any shortcomings as soon as possible. Up-to-date information will help the Member State authorities to better assess whether the concern indicated by the screening is confirmed, and whether regulatory action is still considered appropriate.
ECHA Forum Begins Project On Extended SDSs, Exposure Scenarios, Risk Management Measures, And Operational Conditions: On June 26, 2015, ECHA announced that the Forum for Exchange of Information on Enforcement will prepare and execute a fifth Coordinated Enforcement Project (REF-5) focusing on obligations related to extended safety data sheets (SDS), exposure scenarios, risk management measures, and operational conditions. According to ECHA, previous enforcement experience indicated that SDSs were often non-compliant. Therefore, the Forum considers it important to focus enforcement efforts in this area, particularly on checking the operation of new mechanisms introduced by REACH, such as the provision of exposure scenarios. ECHA states that the precise scope of the project will be defined during the preparatory phase, with the project inspections executed in 2017 and results expected in 2018. The Forum also chose 14 specific restriction entries for the fourth Coordinated Enforcement Project (REF-4). When joining REF-4, each participating Member State will choose restrictions from this list that are most relevant to their national priorities and market situation. Each Member State will report only inspections related to these chosen restrictions within the project. The REF-4 inspections will occur in 2016, and the report will be available in 2017.
ECHA Proposes 15 SVHCs For Authorization: ECHA announced on July 2, 2015, that its sixth recommendation to prioritize SVHCs for authorization to the European Commission (EC) includes 15 substances that have hazardous properties for human health due to being classified as carcinogenic or toxic for reproduction. ECHA states that it prioritized the following substances from the Candidate List because they are used in high volumes and have widespread uses that may pose a threat to human health or the environment or can potentially be used to replace substances that are already on the Authorization List.:
- 1-Bromopropane (n-propyl bromide);
- 1,2-Benzenedicarboxylic acid, di-C6-8-branched alkyl esters, C7-rich;
- 1,2-Benzenedicarboxylic acid, di-C7-11-branched and linear alkyl esters;
- 1,2-Benzenedicarboxylic acid, dipentylester, branched and linear;
- Bis(2-methoxyethyl) phthalate;
- Dipentyl phthalate;
- Anthracene oil;
- Pitch, coal tar, high temp.;
- 4-Nonylphenol, branched and linear, ethoxylated [substances with a linear and/or branched alkyl chain with a carbon number of 9 covalently bound in position 4 to phenol, ethoxylated covering UVCB- and well-defined substances, polymers and homologues, which include any of the individual isomers and/or combinations thereof];
- Boric acid;
- Disodium tetraborate, anhydrous;
- Diboron trioxide; and
- Tetraboron disodium heptaoxide, hydrate.
The EC, in collaboration with the Member States and European Parliament (EP), will make the final decision on the inclusion of the substances in Annex XIV and on the dates by which companies will need to apply for authorization.
ECHA Publishes Workshop Report On Use Of REACH And CLP Information At Industrial Sites: ECHA published on July 6, 2015, a report following an April 2015 workshop on the use of REACH and classification, labeling, and packaging (CLP) information at industrial sites. ECHA states that the workshop explored new ways and potential efficiency gains on using REACH and CLP information to enhance the safe use of chemicals at industrial sites. It also aimed to support compliance under the main environmental and occupational health directives. According to ECHA, during the workshop, it was noted that the potential of information generated under REACH and CLP is not being fully used to support other occupational safety, health, and environment regulations. ECHA states that REACH and CLP bring new knowledge on the chemical substances used by industry, but various players in the supply chain all need to have a role to improve the situation. For instance, according to ECHA, there is a need for sector-specific, tailor-made information to suit the right context. ECHA notes that due to REACH and CLP, individual companies understand and structure their chemicals management internally, but formulators have an important role in passing on REACH information in the supply chain.
Companies Appeal ECHA’s Requests For Information Concerning Nanoforms: On July 16, 2015, ECHA announced the following appeals in which the keywords include nanoforms:
- J.M. Huber Finland Oy, Case A-011-2015;
- RHODIA OPERATIONS SAS, Case A-010-2015;
- IQESIL SA, Case A-009-2015; and
- Evonik Degussa GmbH, Case A-008-2015.
The cases all concern silicic acid, aluminum sodium salt. The contested decisions were adopted December 17, 2014, following a compliance check under the dossier evaluation procedure of the submitted registration. In each contested decision, ECHA found that the registration did not comply with the requirements of REACH Article 10(a)(ii), as well as Annex VI, Section 2. ECHA requested that each appellant submit the following information:
- Name, molecular, and structural formula, or other identifier of the substance (Annex VI, 2.1 and 2.2);
- Composition of the substance (Annex VI, 2.3); and
- Description of the analytical methods used (Annex VI, 2.3.7).
In each case, the appellant contends that ECHA breached the principle of legal certainty by requesting information related to undefined terms, such as “forms,” “grades,” and “nanoforms.” Each appellant asks the Board of Appeal to annul the contested decision in so far as it requests the appellant to submit information as identified in the appeal.
ECHA Announces Submission Of First Applications For Union Authorization Of Biocidal Products: ECHA announced on July 22, 2015, the submission of the first two applications for Union authorization of biocidal products according to the procedure established by the Biocidal Products Regulation (BPR). ECHA notes that the ability for companies to apply for Union authorization rather than for national authorization and subsequently for mutual recognitions in all Member States “is one of the main advantages of the regulation that replaced the previous directive. Yet, it has taken nearly two years after the entry into operation of the new regulation for the first such applications to arrive.” ECHA states that it will make technical checking of the two applications before sending them to the evaluating competent authority (eCA). The eCA will make sure that the applications are complete and will assess the dossiers within one year before providing the outcome to ECHA’s Biocidal Products Committee. ECHA expects the opinions of the Biocidal Products Committee to be adopted within a maximum period of six months. The EC will ultimately take the decision on the authorization of the biocidal products at the Union level. ECHA states:
Once a biocidal product is granted a Union authorisation, it can be marketed in all European markets without the need for multiple further authorisation processes in many Member States. When considered successful, it is expected that many more companies will avail of this novel route for the authorisation of biocidal products in the future. A further factor that may influence the number of Union applications is the level of the fees for the two alternative authorisation systems. The EU fee regulation is — in line with the BPR — subject to review by the European Commission over the coming months.
EC Publishes Summary Report On Public Consultation Held Earlier This Year: On July 24, 2015, the EC published a summary of the more than 27,000 responses received to the public consultation on the scientific criteria of endocrine disruptors. The public consultation will feed into the Impact Assessment “which will assess the options outlined in the Roadmap for Defining criteria for identifying Endocrine Disruptors in the context of the implementation of the Plant Protection Product Regulation and Biocidal Products Regulation and will consider the potential effects on health, environment, trade, agriculture and socio-economic aspects in general.” The Impact Assessment will be concluded in 2016, however, the pilot project is expected to be completed in the following months. The results from the pilot project will be presented during the next public workshop in Fall 2015.
MOE Amends Designation Of Risk-Based Products And Their Safety And Labeling Standards: On June 26, 2015, the Ministry of Environment (MOE) released MOE Notice Number 2015-86, “Designation of Risk-Concerned Products and their Safety and Labeling Standards.” The following categories of regular chemical products and biocidal products have been designated as risk-concerned products in accordance with Article 2, Subparagraph 16, of the Act for the Registration and Evaluation of Chemicals (K-REACH):
- Coating/adhesive product group:
- Anti-rust additives; and
- Anti-fogging agents.
- Anti-rust additives; and
- Dye product group:
- Colorant/decolorant agents; and
- Tattoo inks.
- Colorant/decolorant agents; and
- Biocidal product group:
- Insect repellents; and
The Notice establishes standards for maximum content of hazardous chemicals and substance restriction for each product category, and for the biocidal product group, the list of authorized active ingredients has been decided. The Notice also provides labeling standards for the above product categories, including particular label statements in special cases.
MOE Publishes List Of PECs: On July 1, 2015, MOE published the final list of priority existing chemicals (PEC) for registration under K-REACH. The final list includes 510 chemical substances. Companies manufacturing or importing listed PECs will have three years to prepare their registration dossiers, for submission by June 30, 2018. Under Article 9 of the Chemical Control Act (CCA), manufacturers and importers are required to check their products for substances regulated under the CCA and report to MOE if any are present. Because the list of PECs was not issued in final until July 1, 2015, MOE has proposed a six-month interim measure to allow manufacturers and importers to communicate with other parties in their supply chain to confirm the existence of PECs in products that have been already introduced into the Korean market and report this information.
MOE Publishes Draft Amendment To Ministerial K-REACH Decree: MOE announced on July 10, 2015, a draft amendment to the Ministerial Decree for K-REACH. The draft amendment would simplify the dossier submission requirements and appointment of Only Representatives (OR), and introduce measures intended to protect confidential business information (CBI). The revisions would:
- Reduce the data requirement for small volume imports (under 100 kilograms (kg)) if importing for research and development (R&D) purposes;
- Exempt data on the disposal of unused substances if importing in volumes below 100 kg;
- Allow a “one-time” confirmation of registration exemption for substances used for scientific testing/analysis purposes;
- Unify the authority to which OR appointment records must be submitted under the National Institute of Environmental Research;
- Allow foreign manufacturers to submit an amendment report when they change their OR;
- Remove duplicated items on low volume registration application forms;
- Remove the requirement for data on the import volume of each importer from forms 1, 2, 3, 6, 8, and 12; and
- If manufacture or import volumes are lower than one tonne per year, not require reports on post management results.
Comments are due August 20, 2015.