Regulation 2009/1223 and the Cosmetic Products Enforcement Regulations 2013: Great Britain

Updated 9 January 2023

There will be a seven year transition period from 1 January 2021 before businesses have to include the UK Responsible Person details on product labels, provided the EU responsible person details are included. This will enable existing stocks to make their way through the supply chain and reflects the typical shelf-life of a cosmetic and business’ labelling cycles

For more information read here.

Posted in Regulatory

USA Modernization of Cosmetics Regulation Act of 2022 (MoCRA).

Within MoCRA is a long-awaited update to the US’ cosmetics laws, amending Chapter VI of the Federal Food, Drug, and Cosmetic Act (FD&C Act) enacted on 29th December 2022.

Under MoCRA there will be new requirements for ‘responsible persons’ and for facilities manufacturing cosmetics and personal care. 

All existing facilities, domestic and foreign, which manufacture or process a cosmetic product for distribution in the US must register with the FDA no later than one year after the enactment of MoCRA, which was on 29 December 2022. 

Following the deadline, new businesses will have 60 days after beginning manufacturing to register with the FDA.

For more information click here.

Posted in Regulatory

Merry Christmas!

Posted in Uncategorized

USA: National Academy of Sciences Report, “Review of Fate, Exposure, and Effects of Sunscreens in Aquatic Environments and Implications for Sunscreen Usage and Human Health”

“Cosmetics and personal care products companies provide innovative sunscreen products to help protect consumers from the harmful effects of the sun’s ultraviolet (UV) rays. The Personal Care Products Council (PCPC) and our member companies welcome the National Academy of Sciences (NAS) thorough and comprehensive review of the state of the science, released today, on the use of currently marketed sunscreen ingredients, their environmental impact on aquatic environments, and the potential public health implications associated with changes in sunscreen use.

“An ad hoc committee of the NAS calls upon the U.S. Environmental Protection Agency (EPA) to conduct an environmental risk assessment (ERA) of sunscreen UV filters to characterize possible risks to aquatic ecosystems and the species that live within them, including coral. The report identified information gaps and research priorities necessary to inform a tiered approach to the ERA.

“The key conclusions confirm PCPC’s long-held position that there is currently insufficient relevant and reliable scientific data to conduct realistic ERAs and there is not enough scientific data to support sunscreen ingredient bans. Policymakers, regulators and legislators should not make any decisions that impact consumers’ access to FDA-approved sunscreen UV filters until the scientific community reaches an informed consensus.

For more information read here.

Posted in Ingredients, Regulatory

New UK Cosmetic Portal (OPSS) up and running today

Submit cosmetic product notifications

Create an account or sign in to the OPSS if you have used this service before

Notify the Office for Product Safety and Standards (OPSS) about cosmetic products available to consumers in Great Britain (GB).

What you need to do

You need to notify OPSS about every cosmetic product available to consumers in GB.

What you will need to tell OPSS

You will need to tell OPSS:

  • what is in the cosmetic product, including certain nanomaterials
  • the name and details of a contact person for the National Poisons Information Service, or Trading Standards, to get in touch with
  • who the ‘responsible person’ is

The ‘responsible person’ is the individual or company responsible for ensuring the regulations are followed. Every cosmetic product placed on the GB market must have a responsible person.

How to tell the OPSS what’s in the cosmetic product

How you do this depends on whether the product was notified with the EU.

Cosmetic products notified with the EU before 1 January 2021

You can upload the data from your EU notification. You’ll need to:

  • export your data as a ZIP file for each notification – the EU’s Cosmetic Products Notification Portal (CPNP) allows you to do this
  • upload the ZIP files – you can upload 100 files at a time

The ZIP files will not include:

  • the formulation of the product if it was an attached document – you must provide this separately as a PDF, RTF or TXT file
  • any images – you’ll need to provide them for products notified after 31 December 2020
  • details of any nanomaterials in the product

Cosmetic products not notified with the EU

You’ll need to enter information about the product manually.

Posted in Regulatory

COVID-19 Update

I want to reassure you that Oxford Biosciences remains operational, with our business continuing to support all our clients. We are continuing to certify vital hand sanitiser and cleansing products for our clients in the UK, and throughout the world.

The protection of our staff, colleagues and clients is uppermost in our minds during this challenging period for us all.

We do not currently foresee any impact on the continuity of our service, but should the situation change we will post an update immediately. Although we believe the actions we have put in place are appropriate for the current levels of risk, they are under constant review.

To minimise any health risk, we are complying with government guidelines on reducing the spread of COVID-19. Based on the latest information, we are taking the following actions:

  • Providing all staff with sanitisers and other cleaning equipment necessary to ensure safety at workplace.
  • Strictly abiding the government’s advice on social distancing.
  • Encouraging all staff to follow precautionary health measures, including frequent hand washing.  
  • Travelling to and from work but only if it is absolutely necessary and cannot be done from home.

Working from home
All our client files are strictly confidential. GDPR regulations prohibit any of us from working from home.

Limiting non-essential interaction and travel
We are following all Government guidelines with respect to non-essential interactions. We suspended internal meetings and social events several weeks ago. We are also not attending any industry events. These precautions will remain in place for the foreseeable future.

Self-isolation in the event of any symptoms
Staff have been asked to follow Government advice and self-isolate for 7 days should they feel symptoms of this coronavirus, or 14 days if they live in a household with an infected individual.

There are, however, amendments to our services.

  • A few staff members are out of the office so completion of CPSRs may take longer than our normal quoted turnaround times.
  • As Royal Mail is fully operational our post is going out as usual.
  • Our microbiology lab is operational and accepting products for microbial testing. 

We are taking this day by day and we will let you know if anything changes.

We will continue to update our policies as the national and global situation progresses. 

I hope you and your loved ones are healthy and safe. It has been a tough few weeks for all of us as we try adjusting to the new normal. 

Please be mindful, look after yourself and your loved ones. You are not alone. We are in this together.

With my very best wishes,

Allison Wild

Managing Director

Posted in Regulatory

Status of COVID-19

From our government’s website:

High consequence infectious diseases (HCID)

Guidance and information about high consequence infectious diseases and their management in England.

As of 19 March 2020, COVID-19 is no longer considered to be a high consequence infectious diseases (HCID) in the UK.

The 4 nations public health HCID group made an interim recommendation in January 2020 to classify COVID-19 as an HCID. This was based on consideration of the UK HCID criteria about the virus and the disease with information available during the early stages of the outbreak. Now that more is known about COVID-19, the public health bodies in the UK have reviewed the most up to date information about COVID-19 against the UK HCID criteria. They have determined that several features have now changed; in particular, more information is available about mortality rates (low overall), and there is now greater clinical awareness and a specific and sensitive laboratory test, the availability of which continues to increase.

The Advisory Committee on Dangerous Pathogens (ACDP) is also of the opinion that COVID-19 should no longer be classified as an HCID.

The need to have a national, coordinated response remains, but this is being met by the government’s COVID-19 response.

Cases of COVID-19 are no longer managed by HCID treatment centres only. All healthcare workers managing possible and confirmed cases should follow the updated national infection and prevention (IPC) guidance for COVID-19, which supersedes all previous IPC guidance for COVID-19. This guidance includes instructions about different personal protective equipment (PPE) ensembles that are appropriate for different clinical scenarios.

Read more here.

Posted in Regulatory

J&J ordered to pay US$750M in punitive damages over talc

Johnson & Johnson was ordered by a New Jersey jury to pay an additional US$750 million in punitive damages to a group of former Baby Powder users who had already been awarded US$37.2 million as compensation for cancers they blamed on asbestos in the talc-based product.

After the verdict Thursday in New Brunswick, the judge indicated she may reduce the punitive award to US$186.5 million, as per state law, an amount equaling five times the compensatory damages awarded to the plaintiffs last year.Jurors in J&J’s hometown concluded after about two hours of deliberation that the company’s conduct in manufacturing and marketing the product warranted punishment. A separate jury in September found the company liable for the cancers claims and made the initial award for actual damages.

The September verdict was one of five talc cases J&J lost last year, though it prevailed in eight others. J&J, which denies its 135-year-old baby powder line is contaminated with asbestos, still faces more than 16,000 suits from women who mostly say they used the talc-based product for genital hygiene and later developed cancer. Nearly a third of those suits were filed in the last year.

Read more here.

Posted in Regulatory

Coronavirus hit to beauty sector will be worse than SARS

Estee Lauder and L’Oreal lower profit outlook

Cosmetics companies Estee Lauder and L’Oreal said they’ve taken financial hits because of the outbreak. Estee Lauder lowered its profit outlook fiscal 2020 from between $5.85 and $5.93 per share to between $5.60 and $5.70 per share, citing reduced travel and sales in important tourist and shopping areas. L’Oreal said the outbreak has temporarily hurt sales in Asian airports.The companies have previously seen sales thrive in China as wealthy customers purchase luxury products at beauty stores and duty-free shops.

Read more here

Posted in Skincare business

Lyral® banned this month

Hydroxyisohexyl 3-Cyclohexene Carboxaldehyde (HICC) – Lyral® fragrance ingredient banned 23 August 2019.

INCI: 3- and 4-(4-Hydroxy-4-methylpentyl) cyclohex-3-ene-1-carbaldehyde

CAS: 31906-04-4 / 51414-25-6

Also: HICC – Lyral – Hydroxymethylpentylcyclohexenecarboxaldehyde – Kovanol – Mugonal – Landolal

From August 23, 2019, only cosmetic products which comply with the Regulation shall be placed on the Union market.

From August 23, 2021, only cosmetic products which comply with the Regulation shall be made available on the Union market.

For more information click here.

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Posted in Ingredients, Regulatory