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</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.</p> Signup and view all the answers

    What is the main purpose of the UK cosmetics legislation?

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

    What has replaced the EU CPNP in the UK?

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

    What must the Product Information File (PIF) include?

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

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

    <p>English</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</p> Signup and view all the answers

    What regulation governs cosmetics in the UK after Brexit?

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

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

    <p>Both UK and EU laws</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.</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</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.</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</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.</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.</p> Signup and view all the answers

    What is the primary focus of cosmetovigilance?

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

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

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

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

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

    What does CPSR stand for in the context of cosmetovigilance?

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

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

    <p>Mandate corrective action</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</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</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.</p> Signup and view all the answers

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

    <p>20 days</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.</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.</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</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.</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.</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.</p> Signup and view all the answers

    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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