FDA Unveils OTC User Fees and EU Advances Chemical Regulations
Delve into the latest regulatory updates as the FDA announces over-the-counter (OTC) user fees for fiscal year 2023, with an 8% increase from the previous year. Explore the inclusion of BMHCA in the REACH Authorisation List, Sweden's proposal for p-cymene classification, and the extended submission deadlines for UK REACH, providing a comprehensive overview of evolving chemical regulations.
FDA Unveils OTC User Fees and EU Advances Chemical Regulations
FDA Announces OTC User Fees
On 24 March the FDA announced the rates for over-the-counter (OTC) monograph drug user fees for fiscal year 2023 in a Federal Register Notice (FRN).
The FRN publishes fees for OTC monograph drug facilities and OTC Monograph Order Requests (OMOR) for FY 2023. Fees are calculated on factors that include the number of fee-liable facilities, the ratio of monograph drug facilities and the increases in total target revenues due to inflation.
The FY 2023 facility fee rates are an 8 percent increase on the FY 2022 facility fee rates.
The FDA has issued a draft guidance for the industry, providing stakeholders with information regarding the FDA's implementation of the OMUFA user fee program.
BMHCA added to ECHA Recommendation of Substance for the Authorisation List
On 12 April the ECHA submitted its 11th recommendation to the European Commission of substances to be added to the REACH Authorisation List.
Substances recommended to be included in the Authorisation List are considered to be substances of very high concern (SVHC). Once a substance is added to the Authorisation List, the producer, importer or downstream users must apply for authorisation before placing the substance on the EU market.
BMHCA or Butylphenyl Methylpropional commonly known as Lilial, is a CMR substance, prohibited for use in cosmetic products in the EU under Annex II of Regulation (EC) 1223/2009.
BMHCA is a synthetic fragrance ingredient used in several non-cosmetic products including household cleaners and detergents. SCCS Opinions have raised concern about the ingredient including risk inducing of skin sensitisation, noting the substance as "not safe" for human health.
Under the Classification, Labelling and Packaging Regulation (CLP), BMHCA is classified as toxic to reproduction (Repr. 1B - CMR 1B). This means mixtures containing BMHCA below 0.3% will be exempted.
Sweden Submits CLH Proposal for p-cymene as Rep 1B
The registry of classification and labelling (CLH) intentions lists the intentions and proposals received by ECHA for a new or revised harmonised classification and labelling of a substance.
p-cymene is currently classified as the following:
- Flam. Liq. 3, H226
- Acute Tox. 3, H331
- Asp. Tox 1, H304
- Aquatic Chronic 2, H411
At the time of the proposal the specific concentration limit is: ATE 3mg/l (vapours) .
Sweden's proposed harmonised classification is Repr. 1B, H360FD.
Extended UK REACH Submission Deadlines
The draft statutory instrument for extending UK submission deadlines was laid before Parliament on the 20 April. The statutory instrument is expected to be enacted and in force by Q3 2023, pending parliamentary scrutiny and approval.
UK REACH regulates chemical substances in Great Britain. After leaving the EU, all substances manufactured in or imported to England, Scotland and Wales must be registered with HSE. Interested parties have since raised concerns regarding the high cost of acquiring the necessary hazard, use and exposure data to complete registration in time. The Government have since responded with a draft statutory instrument to extend the registration submission deadlines.
Once in force, the statutory instrument will extend the submission deadlines from October 2023, 2025, and 2027 to October 2026, 2028 and 2030, retrospectively.
Originally published at worldover.io