April 2017 Regulatory Update

In the final rule, the ASTM F2670-17 Standard Consumer Safety Specification for Infant Bath Tubs is adopted. An infant bath tub is defined as a tub, enclosure, or other similar product intended to hold water and be placed into an adult bath tub, sink, or on top of other surfaces to provide support or containment, or both, for an infant in a reclining, sitting, or standing position during bathing by a caregiver. However, products commonly known as bath slings typically made of fabric or mesh are excluded from the scope of the standard.

The final rule will be effective October 2, 2017.

In the proposed rule, the newly published ASTM F3118-17 Standard Consumer Safety Specification for Infant Inclined Sleep Products was adopted in order to reduce the chance of injury associated with inclined sleep products. An infant inclined sleep product is defined as a product:

1. Intended for infants up to 5 months old (3 months for certain smaller products)
2. Intended primarily and marketed to provide sleeping accommodations
3. Having at least one inclined sleep surface which is between 10 and 30 degrees

The proposed rule is currently under comment period until June 21, 2017.

The chemical details are provided below:

The chemical details are provided below:

The effective date of the listing of Glyphosate will be determined following a decision from the Court of Appeal regarding a request for a stay in the pending case (Monsanto v OEHHA).

Meanwhile, OEHHA proposed to adopt a Proposition 65 No Significant Risk Level (NSRL) of 1100 mg/day for Glyphosate and it is currently in comment period until May 22, 2017.

In this proposed action, no new provisions will be added and sections 25607.30 and 25607.31 will be removed due to the conflict with the regular rulemaking adopted previously (See previous story in Regulatory Recap: January 2017). Therefore, upon approval, canned and bottled foods and beverages that cause exposures to BPA are deemed in compliance if the standard point-of-sale warning is provided according to section 25603.3 (f) and (g) of CCR.

In the adopted rule, two flame retardants chemicals, Deca BDE and HBCD, are designated as priority chemicals under the Maine Toxic Chemicals in Children’s Product Law. Therefore, manufacturers of the following children’s products are required to submit information to the DEP before August 31, 2017 if the concentration of these chemicals is more than the Practical Quantification Limit (if intentionally added) or greater than or equal to 100 ppm (if present as a contaminant):

1. Child Care Article
2. Children’s Sleepwear
3. Children’s Toy
4. Children’s Clothing
5. Children’s Footwear
6. Electronic Device
7. Household furniture and Furnishings
8. Mattress
9. Mattress Pad

Compared to the previous proposal (See Regulatory Recap: December 2016), the following modifications have been made in the updated proposal:

1. Changed the date for manufacturers to start reporting children’s products containing a CHCC higher than the de minimis level to January 1, 2019 (annually thereafter).
2. Confirmed the addition and removal of CHCCs (see below):

New chemicals proposed to be listed as CHCCs:

Current CHCCs proposed to be delisted:

Recent 60-day notices from January to March of 2017 include the following:

The proposed chemical details are provided below:

The consultation ended on April 24, 2017.

The proposed SVHCs to be listed as Authorized Chemicals are provided below:

1. 5-sec-butyl-2-(2,4-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane [1], 5-sec-butyl-2-(4,6-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane [2] [covering any of the individual stereoisomers of [1] and [2] or any combination thereof] (karanal group)
2. 1-Methyl-2-pyrrolidone (NMP)
3. 2-(2H-benzotriazol-2-yl)-4,6-ditertpentylphenol (UV-328)
4. 2,4-di-tert-butyl-6-(5-chlorobenzotriazol-2-yl)phenol (UV-327)
5. 2-(2H-benzotriazol-2-yl)-4-(tert-butyl)-6-(sec-butyl)phenol (UV-350)
6. 2-benzotriazol-2-yl-4,6-di-tert-butylphenol (UV-320)
7. 1,2-benzenedicarboxylic acid, di-C6-10-alkyl esters; 1,2-benzenedicarboxylic acid, mixed decyl and hexyl and octyl diesters with ≥ 0.3% of dihexyl phthalate (EC No. 201-559-5)

The consultation ends on June 2, 2017.

In the proposal, the lead restriction under REACH is proposed to be expanded to any Polyvinyl Chloride (PVC) article placed on the market. Due to the fact that the exposure to lead can result in severe neurobehavioral and neurodevelopmental effects at a low dosage, the ECHA proposes to restrict PVC articles if the lead is used as a stabilizer at concentration exceeding 0.1% by weight. Example products include:

1. Window profiles
2. Fittings, pipes and tubes
3. Rolling shutters and gutters
4. Wires and cables
5. Roof and flooring tiles etc.

However, the following products that are covered by existing legislation are not subject to the proposed restriction:

1. Food contact materials (Regulation (EC) No. 1935/2004 and Regulation (EC) No. 10/2011)
2. Electrical and electronic equipment (Directive 2011/65/EU)
3. Packaging (Directive 94/62/EC)
4. Toys (Directive 2009/48/EC)

The public consultation ends on September 22, 2017.

In the restriction proposal supported by RAC and SEAC, four phthalates including DEHP, DBP, DIBP and BBP are restricted under Regulation (EC) No. 1907/2006 (REACH) in the following conditions:

1. Mouthed or prolonged skin contact articles
2. 2. Articles that are used or stored in an indoor environment (where people are present under normal and reasonably foreseeable conditions and can potentially be exposed via inhalation)

1. Articles placed on the EU market prior to the application of the restriction
2. Food contact materials (Regulation (EC) No. 1935/2004 and Regulation (EC) No. 10/2011)
3. Immediate packaging of medicinal products (Regulation (EC) No. 726/2004, Directive 2001/82/EC or Directive 2001/83/EC)
4. Medical devices (Directive 90/385/EEC, Directive 93/42/EEC & Directive 98/79/EC)
5. Toys and childcare articles containing DEHP, DBP and BBP as they are already covered under restriction (entry 51 of Annex XVII of REACH) but not those articles containing DIBP
6. Measuring devices for laboratory use

The guidance document covers a wide range of essential REACH processes as well as some scientific and/or technical methods that industry or authorities need under the regulation. The new version of guidance provides a more comprehensive update aimed primarily at further aligning the text. Apart from this, new examples that are consistent with the conclusions of the Court judgement are provided for stakeholder’s better understanding.

* Other Hazards include Asphyxiation Hazard, Burn Hazard, Cut Hazard, Drowning Hazard, Entrapment Hazard, Environmental Hazard, Fire Hazard, Hearing Hazard, Microbial Hazard and Sight Hazard with a frequency of less than 15.

^ Other Categories include Candles & Burning Items and Accessories, Computer / Audio / Video / Other Electronics & Accessories, Consumer Chemicals, Cosmetics / Bodycare, Footwear, Furniture, Homeware (Non-food Contact), Jewelry, Watch or other Fashion Accessories, Sporting Goods / Equipment and OTC Drug with a frequency of less than 15.

Download the complete Recalls Summary - EU (February and March 2017)