The acquired cohort contains 7 official alert references published from 2012-04-06 to 2019-08-16. This page compares 2 selected, distinct product descriptions, including ballpoint pen. The other 5 records still contribute to the cohort counts but are not displayed: descriptions may repeat, lack the display inputs, or fall outside the eight-description display limit. The recorded risks raise separate evidence questions about nickel. Compare the product features and dated findings below before scoping an investigation. These historical observations do not determine your product’s compliance or a market failure rate.
Evidence retrieved 2026-10-07. Source versions and topic-specific limits are listed below.
Dated official observations
Compare the product features and reported failure mechanism
The source wording below describes the reported case at that time. Read each complete report before using it in an investigation.
Ballpoint pen · A12/1224/19
Report published 2019-08-16 · notifying country Germany · reported origin People's Republic of China
Reported product description
Silver-coloured metal ballpoint pen packaged in plastic and cardboard [1]
Reported risk explanation
The front part of the pen releases an excessive amount of nickel (measured value: 23.3 μg/cm²/week). Nickel is a strong sensitiser and can cause allergic reactions if present in articles that come into direct and prolonged contact with the skin.The product does not comply with the REACH Regulation. [1]
Reported measures, verbatim
Type of economic operator to whom the measure(s) were ordered: ImporterCategory of measure(s): Withdrawal of the product from the marketDate of entry into force: 18/06/2019 [1]
Report published 2019-08-02 · notifying country Germany · reported origin People's Republic of China
Reported product description
Small metal ballpoint pen to which a printed label is attached. [2]
Reported risk explanation
The pen releases an excessive amount of nickel (measured value: 1.20 μg/cm²/week). Nickel is a strong sensitiser and can cause allergic reactions if present in articles that come into direct and prolonged contact with the skin.The product does not comply with the REACH Regulation. [2]
Reported measures, verbatim
Type of economic operator taking notified measure(s): ImporterCategory of measure(s): Withdrawal of the product from the marketDate of entry into force: 13/06/2019 [2]
7 distinct official alert references, published between 2012-04-06 and 2019-08-16. Counts describe the acquired reports, with no market denominator.
Report year
Recorded alerts
2012
2
2014
3
2019
2
Recorded risk labels within this evidence task
Label combinations are source facts within one comparison; they do not create separate guides with identical preparation tasks.
Chemical: 7 recorded references
Source selection, exclusions and calculation method
Filter the acquired, completely parsed English weekly XML releases. Deduplicate official alert references. Group by product category and the complete set of conditional evidence-question topics supported by actual risk text. Risk-label combinations remain recorded cohort facets and do not create buyer intents. Brand, product name, model, origin, notifying country, measurement-only changes and different wording of the same questions do not create intents. Unrecognized mechanisms stay internal for enrichment. Count report years and notifying countries deterministically. Display at most eight newest descriptions with at least 40 characters after whitespace normalization, nonempty reported measures and distinct casefolded descriptions; break date ties by official identifier. All cohort records count even if their description is shorter or not displayed. This is not a representative sample. Counts concern this acquired corpus only.
One acquired version per official public alert reference. Display at most eight newest distinct product descriptions whose normalized whitespace-collapsed text contains at least 40 characters and has nonempty reported measures; ties sort by official identifier. The complete cohort includes shorter descriptions. This is an explicit display selection, not a representative sample.
2 distinct descriptions displayed; 5 cohort records not displayed. Missing fields: {'measures': 2}.
These are selected, dated enforcement observations in the acquired weekly reports, not a random market sample, market-wide failure rate, proof of current product status, or a determination about your product. Notification country is not a complete sales-market or jurisdiction-coverage field. A quoted legal/standard reference is the report’s statement, not independently verified current law or a mandatory test panel.
Calculation safety-gate-evidence-comparison-10; units recorded alerts; no incidence denominator.
Turn the reported failure mechanism into a scoped investigation
Use this checklist to gather your business or product details before speaking with a specialist. The items below explain what to record and suggest useful supporting documents. You can add your own answers in the editable project brief.
Metal-contact configuration and analytical scope — what evidence do we have?
Record the metal/finish identity and actual skin-contact/use conditions. Check whether the reported concern is composition or release, and whether your analytical method and sample represent the relevant surface. Do not substitute one measurement type for another.
Useful evidence: Material/finish and contact-use details, supplier and analytical method/results, surface/lot traceability and current criterion review.
Can we trace the affected component, formula or design revision across our supplied products?
Compare the reported descriptions with your own identifiers and change records. Treat missing or “Unknown” source fields as unresolved; they do not establish that no action was needed.
Useful evidence: Product identifiers, revision history, supplier/batch traceability and market/operator records.
Who would own an evidence review and any resulting corrective-action decision?
Read the reported measures as historical observations. Establish your own operator roles, sector-specific rules, decision owner and communication responsibilities before adopting another case’s response.
Conditional: Product-risk evidence and operator-role review — Compare the recorded product features and failure mechanism with your product. Confirm the applicable product regime, deciding evidence, operator responsibilities and justified next steps. This does not assume that GPSR or a representative appointment applies to every alert category.
Questions for providers
Which specific product features and reported risk mechanism make these cases relevant or irrelevant to our product?
What current legal, standards or scientific sources support your proposed investigation criteria, and what cannot be concluded from these dated alerts?
Which existing evidence can answer the risk question, what additional work is justified, and who owns any resulting corrective-action decision?
Sources and data dates
Read the official document in context. The audit details identify the precise locators and preserved versions used for this page.
