UK Cosmetics Regulations Quiz
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Questions and Answers

How long must animal testing data be kept after the last batch is placed on the market?

  • 5 years
  • Indefinitely
  • 10 years (correct)
  • 15 years

What is one requirement for the responsible person (RP) before a cosmetic product can be placed on the market?

  • The product must have undergone a marketing campaign.
  • The product must have been tested by consumers.
  • The RP must have a certificate of completion.
  • A cosmetic product safety report must be created. (correct)

Which of the following is NOT considered in the safety assessment of a cosmetic product?

  • Systemic exposure to ingredients
  • Weight-of-evidence approach
  • Intended use of the product
  • Consumer preferences (correct)

What does Cosmetovigilance primarily involve?

<p>Monitoring and evaluating adverse effects of cosmetic products (A)</p> Signup and view all the answers

According to the weight-of-evidence approach, which of the following is true?

<p>All relevant data should be reviewed in the safety assessment. (C)</p> Signup and view all the answers

What is the main purpose of the UK cosmetics legislation?

<p>To ensure safety and facilitate trade (B)</p> Signup and view all the answers

What has replaced the EU CPNP in the UK?

<p>Submit Cosmetic Product Notification (SCPN) (B)</p> Signup and view all the answers

Who must be the responsible person for cosmetics placed on the market in the UK?

<p>A responsible person based in the UK (D)</p> Signup and view all the answers

Which organization is now responsible for reporting issues concerning cosmetics in the UK?

<p>The Office for Product Safety and Standards (OPSS) (B)</p> Signup and view all the answers

What must the Product Information File (PIF) include?

<p>Cosmetic Product Safety Report (CPSR) (A)</p> Signup and view all the answers

What compliance mark has replaced the reversed epsilon mark for aerosols in the UK?

<p>UKCA compliance mark (B)</p> Signup and view all the answers

Under the current UK legislation, what language must the PIF be available in?

<p>English (A)</p> Signup and view all the answers

Which of the following is NOT part of the Cosmetic Product Safety Report (CPSR) in the PIF?

<p>Clinical trial results (D)</p> Signup and view all the answers

What regulation governs cosmetics in the UK after Brexit?

<p>GB Cosmetics Regulation (Schedule 34) (C)</p> Signup and view all the answers

Which countries' laws must products sold in Northern Ireland comply with?

<p>Both UK and EU laws (B)</p> Signup and view all the answers

What is the significance of the 'green channel' established by the Windsor Framework?

<p>It facilitates the movement of products from GB to NI for UK use only. (B)</p> Signup and view all the answers

When did the European Cosmetics Regulation (EC) No. 1223/2009 come into force in full in the UK?

<p>1 January 2013 (B)</p> Signup and view all the answers

What does the Northern Ireland Protocol state regarding products received from GB after 27th February 2023?

<p>They can go through a 'green channel' if for UK use. (D)</p> Signup and view all the answers

Which of the following products generally qualifies to be sold in GB according to the regulations?

<p>Qualifying products from NI made subject to EU law (D)</p> Signup and view all the answers

What was the UK's status regarding the EU when it comes to cosmetics regulations before leaving on 31 January 2020?

<p>Subject to EU laws in full until 2020. (C)</p> Signup and view all the answers

What was the main change in how products from GB are treated when entering NI after the Windsor Framework?

<p>They can enter through a streamlined process if for UK use. (C)</p> Signup and view all the answers

What is the primary focus of cosmetovigilance?

<p>Tracking adverse reactions to cosmetic products used by consumers (C)</p> Signup and view all the answers

Which of the following defines a serious undesirable effect (SUE)?

<p>An undesirable effect leading to disability, hospitalisation, or death (C)</p> Signup and view all the answers

What must companies do upon receiving a report of a serious undesirable effect?

<p>Report the SUE to authorities within the specified timeframe (A)</p> Signup and view all the answers

Under which article of the regulations is the legal obligation for cosmetovigilance specified?

<p>Article 23 (C)</p> Signup and view all the answers

What is NOT included in the definition of an undesirable effect?

<p>Misuse of the product (B)</p> Signup and view all the answers

Which entity is responsible for receiving notifications of serious undesirable effects (SUEs) in the UK?

<p>Office for Product Safety and Standards (OPSS) (A)</p> Signup and view all the answers

What is the first piece of information required when reporting to the competent authority regarding an adverse reaction to a cosmetic product?

<p>Identifiable reporter (A)</p> Signup and view all the answers

What does CPSR stand for in the context of cosmetovigilance?

<p>Cosmetic Product Safety Regulations (A)</p> Signup and view all the answers

How quickly must serious undesirable effects (SUEs) be reported in the UK after being informed?

<p>Within 30 calendar days (B)</p> Signup and view all the answers

Which database has replaced the EU databases RAPEX and ICSMS in the UK?

<p>UK Product Safety Database (C)</p> Signup and view all the answers

What outcome may NOT necessarily follow an adverse reaction to a cosmetic product?

<p>Mandate corrective action (C)</p> Signup and view all the answers

What type of information is documented by market surveillance authorities when creating 'cases' for non-compliant products?

<p>Evidence and corrective actions (D)</p> Signup and view all the answers

Which of the following is NOT a required element in the description of a reported cosmetic product?

<p>Product expiry date (C)</p> Signup and view all the answers

What is the process a company must follow after receiving information of an adverse effect related to a cosmetic product?

<p>Notify authorities and gather information. (B)</p> Signup and view all the answers

Which timeframe is specified for reporting serious undesirable effects (SUEs) in the EU?

<p>20 days (A)</p> Signup and view all the answers

What is required for a company to maintain records related to an adverse reaction under GDPR?

<p>Consent from the consumer. (A)</p> Signup and view all the answers

What must be included in the notification of serious undesirable effects to the Secretary of State in the UK?

<p>Corrective measures taken by the responsible person. (C)</p> Signup and view all the answers

Which of the following is NOT a part of the consumer information collecting questionnaire?

<p>Social media usage (C)</p> Signup and view all the answers

What should a company do if no causality is determined from an adverse reaction assessment?

<p>Do not include it in the PIF or submit it. (D)</p> Signup and view all the answers

Which body must be notified of all known serious undesirable effects in the UK?

<p>The Secretary of State. (D)</p> Signup and view all the answers

What information is required for identifying the cosmetic product when reporting SUEs?

<p>The name of the cosmetic product. (C)</p> Signup and view all the answers

Flashcards

European Cosmetics Regulation (EC) No. 1223/2009

A regulation that governs the production, marketing and sale of cosmetics in the European Union.

GB Cosmetics Regulation (Schedule 34 of the Product Safety and Metrology etc (Amendment etc) (EU Exit) Regulations 2019)

The regulations governing cosmetics in Great Britain (England, Scotland and Wales) after Brexit.

Great Britain

The part of the UK that includes England, Scotland, and Wales, separate from Northern Ireland.

The Northern Ireland Protocol

The agreement that established special arrangements for Northern Ireland after Brexit.

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Green Channel

A simplified process for goods moving between Great Britain and Northern Ireland that are intended to be used within the UK.

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31 January 2020

The date the UK left the European Union.

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Transition period

The period following the UK's departure from the EU during which the UK continued to apply EU law.

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31 December 2020

The date the transition period following the UK's exit from the EU ended.

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Cosmetovigilance

The process of collecting, analyzing, and monitoring reports of adverse effects (like skin irritation or allergies) associated with cosmetic products.

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Cosmetic Product Safety Report (CPSR)

A report that summarizes the safety assessment of a cosmetic product. It includes information on the product's ingredients, intended use, and potential risks.

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Responsible Person (RP)

The legal entity responsible for ensuring the safety of a cosmetic product. They are usually the manufacturer or importer.

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Undesirable Effects (UEs)

Undesirable effects (like allergic reactions) that occur during or after using a cosmetic product. These are reported in Cosmetovigilance.

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Weight-of-evidence approach

A systematic approach to evaluating safety data from various sources to make a judgment about the safety of a cosmetic product.

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Product Information File (PIF)

The document containing mandatory information about a cosmetic product, including its formulation, safety assessment, and manufacturing process.

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Responsible Person

A person legally responsible for ensuring a cosmetic product meets safety standards and regulations before being placed on the market.

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Submit Cosmetic Product Notification (SCPN)

A system for registering cosmetic products in the UK, replacing the EU's CPNP.

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UKCA compliance mark

A mark indicating a product meets UK safety standards, replacing the reversed epsilon mark used for aerosols.

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Safety Assessor

A person qualified in fields such as pharmacy, toxicology, or medicine who conducts the safety assessment for a cosmetic product.

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UK Cosmetics Legislation

The legal framework governing the manufacture, labeling, and marketing of cosmetic products in the United Kingdom.

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Good Manufacturing Practice (GMP)

A set of quality controls and manufacturing practices that ensure the consistency and safety of cosmetic products.

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What is Cosmetovigilance?

Monitoring adverse reactions to cosmetic products by consumers.

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Serious Undesirable Effect (SUE)

An undesirable effect causing temporary or permanent disability, hospitalization, congenital abnormalities, or immediate vital risk or death.

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What is OPSS?

The UK's authority responsible for receiving reports of Serious Undesirable Effects from cosmetic products.

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What are company responsibilities for Cosmetovigilance?

Companies must collect information, assess causality, report SUEs, and update product information.

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UK Cosmetics Regulation

The UK's formal regulations, including the Cosmetic Products Enforcement Regulations 2013, which governs cosmetic products.

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How quickly must SUEs be reported to OPSS?

Within 30 calendar days of becoming aware of a possible SUE.

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Correct interpretation of alleged undesirable effects

The responsibility of the company to understand and act on reported issues.

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What is a SUE?

A serious undesirable effect (SUE) is a severe, unexpected or unintended adverse reaction to a cosmetic product.

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Who is the RP?

The Responsible Person (RP) is legally responsible for the safety of a cosmetic product. This is the company that manufactures or imports the product.

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What is a CPSR?

A CPSR (Cosmetic Product Safety Report) is a document that summarizes the safety data for a cosmetic product. It includes information on the ingredients, possible risks, and how to use the product safely.

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What is a PIF?

The PIF (Product Information File) is a comprehensive file that contains all the information about a cosmetic product, including the CPSR. It's needed for the product to be legally marketed.

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What is a causality assessment?

When a company receives a report of an adverse reaction to a cosmetic product, they must assess whether the product caused the reaction. This process is called a causality assessment.

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What happens if a cause is found?

If a company determines that their cosmetic product caused a SUE, they need to update the CPSR and PIF with this information.

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Who needs to be notified of SUEs?

The RP is required to report all known or reasonably expected SUEs to the UK OPSS (Office for Product Safety and Standards).

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What information needs to be provided about the product?

The RP must also provide the specific name of the cosmetic product involved in the SUE to allow for proper identification.

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SUS Reporting

A detailed report submitted to authorities about a suspected adverse reaction caused by a cosmetic product.

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UK Product Safety Database

A database managed by the Office for Product Safety and Standards in the UK, where reports of unsafe products are published.

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Creating a 'case' in the UK Product Safety Database

A procedure initiated by market surveillance authorities in the UK to investigate and address reports of unsafe and non-compliant products.

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Complete withdrawal of a cosmetic product

The most severe response to a reported adverse reaction, involving the complete removal of the product from the market.

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Corrective Action for a Cosmetic Product

Actions taken to minimize or eliminate the risk associated with a product. These can range from simple label updates to complete product recalls.

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Study Notes

Cosmetics Legislation Refresher and Cosmetovigilance

  • The European Cosmetics Regulation (EC No. 1223/2009) is a key regulation.
  • The UK Cosmetics Regulation (Schedule 34 of the Product Safety and Metrology etc (Amendment etc) (EU Exit) Regulations 2019) applies to England, Scotland, and Wales.
  • The Northern Ireland Protocol affects product sales in Northern Ireland. Products sold in GB (England, Scotland, and Wales) must comply with UK law. Products sold in NI must comply with EU law.
  • UK cosmetics legislation, as of January 1, 2021, is a modified version of the European Regulation (EC 1223/2009), with changes incorporated into Schedule 34 of the 2019 Regulations.
  • The UK and EU cosmetic regulations remain largely similar.
  • Key changes include the removal of provisions related to freedom of movement between member states. Reporting now goes to the UK Secretary of State (Office for Product Safety and Standards (OPSS)) instead of the EU Commission.
  • The main goal of the legislation is product safety and facilitating trade.
  • The legislation defines the Product Information File (PIF) required for each cosmetic product before it is sold.
  • The PIF contains mandatory information, including a Cosmetic Product Safety Report (CPSR).
  • The CPSR must be kept up to date for 10 years after the last product batch is sold.

Safety Assessment (Article 10)

  • The responsible person (RP) must ensure the cosmetic product complies with Article 3 (safety) before it is sold.
  • The intended use and potential systemic exposure to individual ingredients must be considered in the safety assessment.
  • An appropriate weight-of-evidence approach, reviewing all existing data sources, is necessary for the assessment.
  • The cosmetic product safety report must be continually updated with additional data.

Cosmetovigilance

  • Cosmetovigilance is the monitoring of adverse reactions to cosmetic products used by consumers. It's a legal obligation for responsible persons (RPs) and distributors.
  • The aim is to detect any potential safety concerns.
  • Safety data gathered after a product is on the market is also crucial.
  • The UK and EU have different reporting authorities for undesirable effects, with the UK using the Office for Product Safety and Standards (OPSS), and the EU having the EU Commission.

Reporting Obligations

  • Companies are obliged to report serious undesirable effects (SUEs) "without delay" to the relevant UK authority (OPSS) or, if within the EU, the member state's competent authorities.
  • The reporting time frame is within 30 calendar days in the UK (compared with 20 days timeframe in the EU). The report includes details of the undesirable effect, the specific cosmetic product, and any corrective actions taken.
  • Specific reporting forms and procedures are available.
  • The Office for Product Safety and Standards (OPSS) maintains a UK Product Safety Database to publish details of products found to pose a risk to consumer safety.

Further Information

  • The UK Product Safety Database collects information related to unsafe and non-compliant products.
  • Adverse reaction outcomes can range from product recall to withdrawal. Corrective actions are not always necessary in cases that are not product-related.
  • The steps for handling cosmetic product-related undesirable events include reporting, assessment, and, if necessary, corrective procedures.

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Related Documents

UK EU Cosmetics Regulations 2019 PDF

Description

Test your knowledge on UK cosmetics regulations, including data retention for animal testing, safety assessments, and the Responsible Person's requirements. Learn about the changes from EU to UK laws and the essentials of the Product Information File.

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