Self-declaration

EC Self Declaration (Annex VII) EC Self Declaration (Annex... 

Olsen et al. (1995) studied mortality among a cohort of 548 male l,2-dibromo-3-chloropropane production workers. This was an update of an earlier study performed by Heam et al. (1984). The workers were identified on the basis of employment records or self-declaration of exposure to l,2-dibromo-3-chloropropane and were followed from 1957 through 1989. A total of 68 deaths were identified (standardized mortality ratio (SMR), 0.8) and overall cancer mortality was similar to expected (SMR, 1.0 n = 19), based on mortality of white men in the United States. There were seven lung cancer deaths compared with 7.1 expected (SMR, 1.0 95% confidence interval (Cl), 0.4-2.0), but an excess of lung cancer (SMR, 3.4 95% CI, 0.7-9.6), based on three cases, was... 

To some extent, these conflicts affect affect Bulgaria, Romania, and Turkey. Thus, Bulgaria with great interest watches the situation with the ethnic Bulgarians living in the Republic of Moldova and in Ukraine. Romania is actively involved in settlement of the Pridnestrovie-Moldavian conflict providing information support to Kishinev. Turkish businessmen provide sizable investments into economic development of the self-declared Republic of Abkhasia. 

Standards Australia [23] has established AS/NZS ISO 14021 2000, Environmental Labels and Declarations - Self-Declared Environmental Claims (type II environmental labelling). This Standard is an adoption with national modifications of ISO 14021 1999 and it specifies requirements applying to the development of environmental claims, expressed in either words or symbols, about products and services. The objective of the standard is to harmonise the various national guidelines on environmental claims used on product labels and in marketing generally, in order to facilitate trade in the global marketplace and to improve consumer confidence in environmental claims. 

In early days IMEP became internationally known because it was one of the few ILCs that was not based on consensus values derived from participants results. Contrary to common belief, the results of the various IMEP comparisons showed an unexpected large spread of participants results even for simple measurements, far from the laboratories own quoted standards of accuracy. To learn more about the origin of this spread, participants in IMEP were also asked to bll in a questionnaire. The questions gather information on the methodological approach, the establishment of traceability via the use of CRMs and the evaluation of uncertainty, the experience of the analyst, the self-declared status of accreditation, and the quality system. Based on general information about the laboratory (e.g., country of origin) and the answers given in the questionnaire, the results obtained... 

Figure 7.14. IMEP-20. Participants results for Se according to self-declared level experience.

In the frame of the EA-IRMM collaboration agreement, 61 laboratories that were nominated via their NABs, reported measurement results in IMEP-20 tuna Fsh. Furthermore, a number of IMEP-20 participants not nominated by EA indicated that they were accredited or/and authorized for this kind of measurements. Figure 7.21 shows the results for As in tuna Fsh according to self-declared accreditation or authorization status. It has to be mentioned that due to the overall large spread of As results in IMEP-20, the scale in this graph is +100 percent... 

For the manufacturer, the CE mark is based on self-declaration made after the risk analysis on the machine has been made. A third party check, in this case of an ENTAM member, checking the procedure places, an additional, voluntary mark on the machine. This guarantees quality control giving added value to the product. 

The role of self-declaration versus third-party auditing... 

All health care professionals who are involved with supplementary prescribing will require continuing professional development (CPD). Practitioners have a responsibility to keep themselves up to date with clinical and professional developments. Since 2005, podiatrists (and others) have also had to meet the requirements of the Standards for Continuing Professional Development of the Health Professions Council. This is a self-declaration, which has to be kept current with practice within an individual s practice. It is subject to periodic audit, requiring the submission of evidence of CPD to the HPC. Employers should allow practitioners access to relevant education and training. The Department of Health has commissioned CPD support for supplementary prescribers through the National Prescribing Centre (see www.npc.co.uk). 

The third trend is the increasing amount of environmental information that manufacturers communicate to customers. Three general approaches for communicating environmental attributes to corporate procurement and consumers have emerged eco-labels, self-declaration, and life cycle assessment. 

Another type of label, self-declaration, allows producers to select methods and metrics. However, comparisons among competing products or services are difficult. Self-declaration is the most flexible form for manufacturers, but its use depends on the manufacturer s environmental reputation among customers. The ECMA, a European industry association that proposes standards for information and communication systems, has proposed product-related environmental attribute standards (Granda et al. 1998). 

Consumers may learn about environmental impacts from eco-labels, self-declaration, and life cycle assessment studies. Industrial engineers may learn about clean manufacturing as universities integrate industrial ecology concepts into business and engineering programs (Santi 1997 Stuart 2000). Important clean manufacturing concepts are defined in the next section. 

Type II Self-Declaration Claims These are environmental claims of products declared by their manufacturers, importers and distributors. There are no accepted criteria that need to be verified independentiy, so this is the least informative type of label. 

Dekhili, S., Achabou, M.A., 2014. Eco-labeUing brand strategy independent certification versus self-declaration. European Business Review 26 (4), 305—329. 

Type n (self-declared environmental claims) is a single-attribute label developed by the producer. It is made without independent third-party certification, by manufacturers, importers, distributots, retailers or anyone else likely to benefit from such a claim. (ISO 14021)... 

Within the European Union, many organisations have decided on a voluntary basis to implement environmental management systems based on EN ISO 14001 1996 or the EU Eco-management and audit scheme EMAS. EMAS includes the management system requirements of EN ISO 14001, but places additional emphasis on legal compliance, environmental performance and employee involvement it also requires external verification of the management system and validation of a public environmental statement (in EN ISO 14001 self-declaration is an alternative to external verification). There are also many organisations that have decided to put in place non-standardised EMSs. 

A declaration of conformity is drawn up by the manufacturer or authorized representative and used to declare that the product has undergone all the necessary assessments and that the product satisfies the essential requirements of the applicable directives. This self-declaration lists the standards and directives applied, the responsible person and other necessary information as required by the directives. 

CE marking is the manufacturer s or supplier s self-declaration symbol to indicate that the product has undergone all the necessary evaluation procedures and is in conformity with the minimum requirements of the relevant directives. Products that conform to all the applicable directives and standards may bear the CE marking. The CE symbol is not a registered trademark and is, in principle, under the manufacturer s control. Products bearing the CE marking may be placed on the market. 

For most products and machines, the self-declaration process (module A) is possible. In practice the manufacturer performs the complete product assessment according to EU standards, issues the declaration, and affixes the CE marking to the product. A technical file or documentation must also be available on demand for national enforcement authorities. Keep in mind that this is an internal self-assessment process, a do-it-yourself approach, that results in issuance of the manufacturer s declaration of conformity and the CE marking (Figure 2-6). The buyer may demand proof of safety/EMC compliance in the form of a mark, certificate, or test report from a European notified or competent body. 

Self-declaration. This route is available for products/machines where a mandatory type exam is not required. This route allows internal control of production through product assessment and testing by the manufacturer. Under self-declaration, the manufacturer takes complete responsibility for the assessment, testing, documentation, and declaration of conformity and CE marking. 

Is a manufacturer s or agent s self-declaration (a do-it-yourself approach) ... 

CE marking is the manufacturers self-declaration symbol indicating conformity with the essential requirements of all relevant directives. The product CE marking and declaration of conformity is mandatory for most products. A technical file describing the product, design, assessment, tests, standards applied, rationale, etc., shall also be readily available. 

The European Commission s goal of single-market access is virtually a reality for companies who follow the New Approach rules. Technical requirements (standards) and laws (essential requirements) exist for the most part to protect the public from interference (EMC) and dangerous occurrences (safety) caused by products. The CE marking is a symbol of the manufacturer s self-declaration to indicate conformity with the minimum requirements, allows products to be placed on the market, and ensures the free movement of goods. ... 

A major problem with products and machines submitted to EU-testing bodies is that they fail assessment because the components do not conform to the relevant standards. Failure is most likely when nonapproved components are used. Since the 1970s (Old Approach) a self-declaration according to the LVD was possible, but most components carrying only a manufacturer s declaration failed when tested by a European body. Under the New Approach nothing has changed. Safety and critical components still must comply with the standards, but those that have only the... 

Testing nonapproved components adds cost, time, and risk since the component often fails the assessment, even when a CE marking or other non-European mark (UL/CSA) are present. Remember, manufacturer s self-declarations for products and components have been allowed under the LVD since 1973 and not generally recognized as evidence of compliance by European testing bodies or enforcement authorities. 

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