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ECHA issued a proposal to add PFAS to REACH restriction


Time:

2023-02-10

On February 7, 2023, ECHA announced the proposal submitted by Denmark, Germany, the Netherlands, Norway and Sweden to ECHA on adding restrictions on the manufacturing, placing on the market and use of PFAS in the REACH restriction section, which has a huge impact!

On February 7, 2023, ECHA published the details of the proposal submitted by Denmark, Germany, the Netherlands, Norway and Sweden to ECHA on adding restrictions on the manufacture, marketing and use of PFAS in the REACH restriction section. At the same time, ECHA has also started to assess the risks to human and environment and the impact on society of the proposal. It is expected that a six-month public consultation will be launched in March 2023, and the European Commission will subsequently issue a decision on whether to add PFAS control in the REACH restriction.

 

PFAS proposal details

PFAS refers to any substance containing at least one perfluoromethyl (CF3 -) or methylene (- CF2 -) carbon atom (without any H/Cl/Br/I).
Substances containing only the following structural elements are not within the limits:
CF3-X or X-CF2-X ', where X=- OR or - NRR'; X '=methyl (- CH3), methylene (- CH2 -), aromatic group, carbonyl (- C (O) -), - OR "", - SR "" or - NR "R"; Where R/R '/R'/R '' is hydrogen (- H), methyl (- CH3), methylene (- CH2 -), aromatic group or carbonyl (- C (O) -)

 

Restrictions

1. It shall not be manufactured, used or put on the market separately as a substance;

 

2. It shall not be put on the market in the following forms
A. Composition of another substance;
B. Mixture,
C. Items
The concentration is higher than or equal to:
I. Any PFAS measured by the target PFAS analysis is 25 ppb (aggregated PFASs are not within the quantitative range)
ii.  As the sum of the target PFAS analysis, the sum of the measured PFAS is 250 ppb, and the precursor can be selected for pre-degradation (polymeric PFASs are not within the quantitative range)
Iii. PFAS is 50 ppm (including polymerized PFAS). If the total fluorine content exceeds 50 mg F/kg, the manufacturer, importer or downstream user shall provide PFAS or non-PFAS fluorine content certificate to the law enforcement agency upon request.

 

3. Articles 1 and 2 apply to 18 months after the restriction comes into force.

 

4. As a relief, Articles 1 and 2 do not apply to
A. Active substances in biocide products within the scope of Regulation (EU) 528/2012
B. Active substances in plant protection products within the scope of Regulation (EU) 1107/2009
C. Scope of Directive (EU) 726/2004, Regulation (EU) 2019/6 and 2001/83/EC
Active substances in human and veterinary drugs
Manufacturers and importers of the active substances mentioned in point a-c shall submit the following information to the regulatory authority every two years:
I. Deduction for the intended use;
ii.  Identification information and quantity of active substances on the market.
ECHA shall publish a summary of the information submitted in point i-ii on its website.

 

5. As a relief, Articles 1 and 2 do not apply to:
A. Help to polymerize the production of PFASs within 6.5 years after the effective date. However, this exemption does not apply to the production of PTFE, PVDF and FKM.
B. The fabric of personal protective equipment (PPE) used to protect users from the risks specified in Annex I, Risk Category III (a) and (c) of Regulation (EU) 2016/425 until 13.5 years after its entry into force;
C. Fabrics used for personal protective equipment (PPE) in professional fire-fighting activities are designed to protect users from the risks specified in Regulation (EU) 2016/425, Annex I, Risk Category III (a) - (m) until 13.5 years after entry into force;
D. A re-impregment agent for the articles mentioned in paragraphs 5b and 5c until 13.5 years after its entry into force;
E. Fabrics used for filtering and separating media, used for high-performance air and liquid applications in industrial or professional equipment, need a combination of water and oil resistance until 6.5 years after the effective date;
F. Refrigerant in low-temperature refrigeration below - 50 ℃ until 6.5 years after the effective date;
G. Refrigerant in laboratory testing and measuring equipment until 13.5 years after the effective date;
H. Refrigerate the refrigerant in the centrifuge until 13.5 years after the effective date;
I. Maintain and replace the existing HVACR (heating, ventilation, air conditioning and refrigeration) equipment that has been put into the market within [18 months after the effective date], and there is no alternative plan at any time within 13.5 years after the effective date;
J. Refrigerant in HVACR (heating, ventilation, air conditioning and refrigeration) equipment in buildings where the use of substitutes is prohibited by national safety standards and building codes;
K. Industrial precision cleaning fluid, up to 13.5 years after the effective date;
L. Cleaning fluid used in oxygen-enriched environment until 13.5 years after the effective date;
M. Clean fire extinguisher substitutes pose risks to the protection of assets or human health until 13.5 years after the effective date;
N. Laboratory diagnostic test until 13.5 years after the effective date;
O. Anti-corrosion/anti-corrosive hydraulic oil additives for hydraulic systems (including control valves) in aircraft and aerospace industries, up to 13.5 years after the effective date;
P. Mobile refrigerant in air conditioning system of internal combustion engine vehicles using mechanical compressor until 6.5 years after the effective date;
Q. Refrigerant used in refrigerated transportation, except for marine applications, until 6.5 years after the effective date;
R. Gas insulation in high-voltage switchgear (higher than 145 kV) until 6.5 years after the effective date.
S. Lubricants used under harsh conditions or required for the safe operation and safety of equipment, up to 13.5 years after the effective date;
T. Calibration of measuring instruments and use as analytical reference materials
After soliciting comments on the Annex XV report, the following possible exemptions are marked as requiring reconsideration:
U. [Fabrics used for sound insulation and vibration isolation in the engine compartment of the automobile industry until 13.5 years after the effective date];
V. [Hard chrome plating until 6.5 years after the effective date];
w. [Foaming foam field spraying, foam foaming agent for building insulation, until 6.5 years after the effective date];
X. [Industrial and professional application of solvent-based unbinding system in 3D printing until 13.5 years after the effective date];
Y. [Industrial and professional use of smoothing agents for polymer 3D printing applications until 13.5 years after the effective date];
z. [Industrial aerosol propellant for applications requiring nonflammable and high-performance spray quality technology, up to 13.5 years after the effective date];
Aa. [For the preservation of paper-based cultural materials until 13.5 years after the effective date];
Bb. [Cleaning and heat transfer: engineering fluid used for medical equipment until 13.5 years after the effective date];
Cc. [Ventilation membrane for medical equipment until 13.5 years after the effective date];
Dd. [Refrigerant and mobile air conditioner for military facilities until 13.5 years after the effective date];
Ee. [Semiconductor manufacturing process, until 13.5 years after the effective period].

 

6. As a relief, Articles 1 and 2 do not apply to fluoropolymers and perfluoropolyether for the following purposes:
A. Food contact materials used for industrial and professional food and feed production until 6.5 years after the effective date;
B. Implantable medical equipment (excluding patch, wound treatment products, catheter and catheter) until 13.5 years after the effective date;
C. Tubes and catheters in medical equipment until 13.5 years after the effective date;
D. MDIs coating until 13.5 years after the effective date;
E. Proton exchange membrane (PEM) fuel cell, until 6.5 years after the effective date;
F. The application of fluoropolymers in the oil and mining industry until 13.5 years after the effective date.
After soliciting comments on the Annex XV report, the following possible exemptions are listed as requiring reconsideration:
G. [Non stick coating in industrial and professional baking appliances until 6.5 years after the effective date];
H. [hernia repair patch, until 13.5 years after the effective date];
I. [Wound treatment products until 13.5 years after the effective date];
J. [Application of coating for medical equipment other than quantitative inhalers until 13.5 years after the effective date];
K. [Rigid breathable corneal contact lenses and glasses, up to 13.5 years after the effective date];
L. [PCTFE-based packaging for pharmaceutical preparations, medical equipment and medical molecular diagnosis until 13.5 years after the effective date];
M. [PTFE (polytetrafluoroethylene) packaging in eyedrops until 13.5 years after the effective date];
N. [Packaging of final sterilization medical devices until 13.5 years after the effective date];
O. [Applications that affect the normal operation related to the safety of transport vehicles, as well as applications that affect the safety of operators, passengers or goods, until 13.5 years after the effective date]

 

7. According to the provisions of Clause 5. b-d, f-t, u, w-ee, 6. b-d, f-h-o, manufacturers and importers of PFAS or PFAS-containing substances and relevant parties using PFAS mixture for preparation shall provide reports to the agency on the 3.31 day of each calendar year after 18 months after the effective date of the regulation, and the report shall contain the following contents:
I. Deduction for the expected use;
ii.  Identification information and quantity of substances put on the market in the previous year. ECHA shall forward the information to the Committee before 6.30 of each year.

 

8. Without prejudice to the provisions of paragraph 7, importers and downstream users of fluoropolymers and perfluoropolyether who apply the exemption in paragraph 5 or 6 should develop a site-specific management plan, which should include:
 i.  Identification information of substances and products used
ii.  Reason for use;
 iii.  Detailed information about use conditions and safe disposal.
The management plan shall be reviewed and kept annually and subject to inspection by law enforcement authorities as required.

 

9. The application of Articles 1 and 2 shall not affect the more restrictive conditions stipulated in this Annex or other applicable EU legislation.

 

 

Particular attention

According to the information released by the US EPA, PFAS (perfluorinated and polyfluoroalkyl compounds) currently contains at least 10000 and is widely used worldwide, such as textiles, food packaging, lubricants, refrigerants and electronic products. It has persistence, long-range mobility, toxicity and bioaccumulation. Relevant evidence shows that the pollution of PFAS to groundwater, surface water and biota has been very common, and the harm to human and environment is serious. At the same time, some PFAS are gases. Once released, they will be distributed around the world and have a significant impact on global climate change. At present, the call for the control of PFAS substances is on the rise around the world. Countries have successively issued relevant control requirements. The controlled objects cover a wide range and need to attract the attention of various manufacturing enterprises.

 

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