Date: Jun 21, 2010
China Solicits Public Comments on the Draft Implementation Documents for the Enforcement of the Environmental Administration Provisions for New Chemical Substances
The Ministry of Environmental Protection (MEP) is soliciting public comments on the six draft implementation documents applicable to the enforcement of the Environmental Administration Provisions for New Chemical Substances (hereafter referred to as "the Provisions"), to be effective October 15, 2010. Comments on these drafts are due by July 1, 2010.
The six documents include the following:
(1) Guideline for Registration and Notification of New Chemical Substances ("the Draft Guideline");
(2) Inspection Rules for the Supervision and Administration of New Chemical Substances;
(3) Regular Notification Form and the Instructions for Filling the Form;
(4) Simplified Notification Form and the Instructions for Filling the Form;
(5) Scientific Research Filing and the Instructions for Filling the Form; and
(6) Initial Activity Report and the Instructions for Filling the Form.
The "Draft Guideline", if adopted, would make significant changes to the currently effective practice by setting new definitions, clarifying ambiguities and imposing new requirements. For all practical purposes, this article focuses on these major changes as they compare to the current version. Please refer to K&H's recent publication entitled "China Promulgates Revised Environmental Administration Provisions for New Chemical Substances" for more details on the Provisions.
1. Definitions and Criteria for Impurities and By-products
The Draft Guideline defines "impurities" as "chemical substances that do not contribute to the function of the product, that may result from raw materials, side reaction or incomplete reaction, and which are not intended to be present in the finished product; the content of any single impurity shall not exceed 10% (of the finished product) and the total content of impurities shall not exceed 20% by weight."
Impurities are not considered to be "for commercial purpose" and are therefore excluded from the obligation of filing a new chemical notification.
Byproducts occurring during reaction are also exempted from the notification although no specific definition for "byproducts" is provided in the Guideline.
2. Intermediates and Non-isolated Intermediates
The Draft Guideline clearly excludes non-isolated intermediates from the scope of new chemical notification. Non-isolated intermediates include those substances which are enclosed in reactors or pipelines as well as those that are temporarily packaged and stored "on-site" intermediates. We consider this to be a favorable clarification for the chemical industry.
3. Intentionally Released Substances from Articles
The notification requirement in the Provisions covers articles which are designed to intentionally release new chemical substances during their use. The Draft Guideline construes "designed to intentionally release" to mean that the release of a new chemical substance from the article is indispensable to the function of the article and where the shape of the article only functions as a container of the new chemical substance, e.g., pen, cartridge, fire extinguisher, and scented erasers.
This clarification is important since the language of the Provisions suggests that articles are subject to registration simply because they contain new chemical substances that are intentionally released during use.
4. More Demanding Data Requirements
Toxicity and ecotoxicity data for each tonnage band are specified in the Draft Guideline. By comparison to the existing requirements, the new data requirements are much more demanding. Please see Table 1 and 2 for further details. For your reference, the current requirements for toxicity and ecotoxicity data are listed in Tables 3 and 4.
For example, reproductive/developmental and toxicokinetics data are required for both Level 2 (10 ≤ Q < 100 t/a) and Level 3 (100 ≤ Q < 1000 t/a) regular notifications; absorption/desorption data (1 ≤ Q < 10 t/a) are required for Level 1 and Level 2 regular notifications; earthworm acute toxicity data are needed for Level 2 and Level 3; and algae 21-day toxicity and bioaccumulation data should be provided for Level 2 regular notifications.
Furthermore, the data requirement is supposedly proportional to the tonnage band, "higher volume, more data", as spelled out in the Provisions. However, the Draft Guideline demands basically the same set of toxicological data for Level 2 and Level 3 regular notifications, and the same set of eco-toxicological data for Level 3 and Level 4 (Q ≥ 1000 t/a) regular notifications. This makes little sense from a regulatory standpoint.
Criteria for certain data waivers are also specified in the Draft Guideline. For instance, absorption/desorption data can be waived for substances which degrade quickly; 90-day repeated dose study data can be waived if (a) the substance is decomposed quickly and the information on the decomposed products is sufficient, or (b) there exists reliable chronic toxicology study data using the same test animals and route of administration.
Such increased data requirements are very demanding and will be potentially troublesome due to the fact that reproductive/developmental toxicological data are not typically available for most chemical substances in the market. This is also true of toxicokinetics data, which are only typically required for substances designated for pharmaceutical uses.
5. Definition for Polymers and "2% Rule" for Nomenclature
As China does not currently have a legal definition for "polymers," macro molecules with certain repeating units can arguably be considered "polymers". However, the Draft Guideline clearly defines "polymer" as a chemical substance consisting of one or more types of monomer units in sequence in which the majority of molecules in such a polymer contain at least three monomer units connected by covalent bonds. It further stipulates that the minority of polymer molecules may have the same molecular weight and that a polymer should have a distributed molecular weight which is attributed to the number of (repeating) monomers units. This definition for polymer is very similar to the one defined by the Organization for Economic Co-operation and Development (OECD) or under Registration, Evaluation, Authorization and Restriction of Chemicals (REACH).
The Draft Guideline also stipulates a "2% rule" for nomenclature concerning polymers, such that any monomer or reactant present at over 2% by weight should be reflected in the nomenclature of the polymer. Up until now, the nomenclature rules for polymers have not been very flexible. The so-called "2% rule" in the current Chinese practice is actually for determining whether a given polymer is entitled to polymer exemption, but not for its nomenclature.
6. Risk Assessment Report
There is an added requirement for Risk Assessment Report in the Provisions and the Draft Guideline for filing Regular Notifications. The Draft Guideline stipulates specific components in a risk assessment report, which includes a summary, identification and characterization of the substance, hazardous assessment (physical and chemical, human health and environmental biological hazards), exposure assessment, risk characterization, risk control measures and conclusion regarding the risk assessment.
7. More Criteria Set for Simplified Polymer Notification
The current polymer exemption application will be converted into one of the scenarios under Simple Notification. However, this is not just a change in terminology. More eligibility criteria are set for polymers in terms of this simplified notification process. In general, the following polymers are not entitled to simplified polymer notification: (1) polymers containing heavy metals or cationic ions; (2) polymers soluble in water; (3) polymers soluble in the selected solvents; (4) polymers unstable in acidic or alkali conditions; (5) polymers that are not otherwise considered to be of "Low Concern."
8. Inspection and Enforcement by Local Authorities
There has been a general disconnection between MEP and its local branches in terms of the awareness and capacity for implementing and enforcing the regulations on new chemical substance registration. However, the Draft Inspection Rules for the Supervision and Administration of New Chemical Substances make it clear that it is local authorities' responsibility to inspect and enforce the Provisions. Specifically, it stipulates that local authorities should conduct at least one on-site inspection of facilities manufacturing or using new chemical substances when the local authorities are notified by MEP that approvals have been granted to new chemical substances. It is also stipulated that such on-site inspection should cover the details of record keeping, implementation of preventive measures and waste disposal. Although it is unclear whether such local inspection and enforcement would be bottle-necked by the limited capacity of the local authorities, it is clear that MEP would prioritize the implementation and enforcement of the new chemical registration regulations.
9. Obligation for Downstream Communication
The Draft Guideline imposes more communication obligations on registrants of new chemical substances. Specifically, registration owners should provide a declaration to its downstream users as to whether its products contain or do not contain new chemical substances. If a specific product does contain new chemical substance(s), the registration owner should evaluate the risk management capacity of its processors or users before the registered new substance is in the custody of its processors/users. Such evaluations should be appropriately documented. Theoretically this sounds reasonable, but we believe this would create tremendous issues from a practical standpoint. First, it would be extremely burdensome if capacity assessment for risk management is required for every customer of a given business. Second, in the case that certain immediate customers of a given business are merely distributors, such requirement would not only make no sense but also create significant ambiguity in terms of compliance.
10. Lack of Grace Period
The Draft Guideline does not set any grace period for the enforcement of the Provisions. Consequently, the Provisions should be implemented and enforced from October 15, 2010 when they become official. Lack of a grace period will be particularly troublesome for those businesses operating under the current exclusion for Free Trade Zones (FTZ) or Export Processing Zones (EPZ), which are no longer excluded under the amended Provisions.
There are also numerous detailed and procedural changes in the overall process that we think to be of less significance compared with those discussed above. As mentioned, some of these provisions will be of particular concern if they are implemented as currently drafted. A coordinated industry effort is highly recommended before these drafted Guideline and Rules become final.
Comments are due by July 1, 2010. If you have any questions, please do not hesitate to contact Wilfred Feng (email@example.com), Jenny Li (firstname.lastname@example.org), Chen Hu (email@example.com), or Mark Thompson (firstname.lastname@example.org) at Keller and Heckman's Shanghai office.
Table 1 Minimal Requirement for Toxicological Data in the Draft Guideline
Proposed Tox Data
1≤ Q < 10 t/a
10 ≤ Q< 100 t/a
100 ≤ Q< 1000 t/a
Q ≥ 1000 t/a
28-day reported dose
90-day Reported dose
"Q"= Petitioned Quantity
Table 2 Minimal Requirement for Eco-Toxicological Data in the Draft Guideline
Alga growth inhibition
Daphnia sp. acute immobilization
Fish acute tox
Activated sludge, respiration inhibition
Earthworm acute tox
Fish, prolonged toxicity, 14-day
Alga 21-day tox
Fish chorionic tox
Seed germination/root elongation tox
Table 3 Minimal Requirement for Toxicological Data
under the Currently Effective Guideline
< 10 mt
10 – 1000 mt
>= 1000 mt
7.1 Acute toxicity
- Skin irritation
- Eye irritation
- Skin allergy
√ (second animal)
7.2 28-day repeated dose
7.3 90-day repeated dose
7.4 Chronic toxicity
- Chromosome abbr
7.10 Dynamic toxicology
Table 4 Minimal Requirement for Eco-toxicological Data
under the Currently Effective Guideline
8.1 Algal growth inhibition toxicity
8.2 Flea acute toxicity
8.3 Fish acute toxicity
√ (local data)
8.4 Bird toxicity
8.5 Higher plant seed germination and growth toxicity
8.6 Earthworm acute toxicity
8.7 Activated sludge respiration inhibition toxicity