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The present application for renewal of the authorisation did not include a proposal for amending or supplementing the conditions of the original authorisation that would have an impact on the efficacy of the additive. Therefore, there was no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.In compliance with Article 43 of Regulation (EC) No 396/2005, the EFSA received from the European Commission a mandate to provide its reasoned opinion on the existing maximum residue levels (MRLs) for methoxyfenozide which might lead to consumers intake concerns on the basis of the new toxicological reference values agreed upon by Member States (MSs) on 13 December 2018. In order to identify the MRLs of potential concern that require a more detailed assessment, EFSA screened the existing MRLs for methoxyfenozide, considering the new toxicological reference values and an acute risk could not be excluded for eight commodities. A fall-back MRL was proposed for tomatoes and the MRL for citrus fruit could be confirmed considering the use of a peeling factor. No other fall-back good agricultural practices (GAPs) were received, and thus, a lowering of the MRLs for peaches, apples, pears and broccoli is proposed.Regulation (EC) No 396/2005 establishes the rules governing the setting and the review of pesticide maximum residue levels (MRLs) at European level. According to Article 12(1) of Regulation (EC) No 396/2005, EFSA shall provide within 12 months from the date of the inclusion or non-inclusion of an active substance in Annex I to Directive 91/414/EEC a reasoned opinion on the review of the existing MRLs for that active substance. Article 12(2) of that Regulation stipulates that EFSA shall provide by 1 September 2009 a reasoned opinion on the review of the existing MRLs for all active substances included in Annex I to Directive 91/414/EEC before 2 September 2008. Among the active substances that need to be reviewed under Article 12(1) or Article 12(2) of Regulation (EC) No 396/2005, EFSA identified 12 active substances for which a review of MRLs is no longer considered necessary, including five active substances that were already included temporarily in Annex IV of Regulation (EC) No 396/2005 by risk managers pending finalisation of their evaluation under Directive 91/414/EEC or Regulation (EC) No 1107/2009 and pending submission of EFSA's reasoned opinion in accordance with Article 12 of Regulation (EC) No 396/2005. EFSA prepared a statement explaining the reasons why a review of MRLs for these substances became obsolete. The relevant question numbers are considered addressed by this statement.The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State the United Kingdom and co-rapporteur Member State Greece for the pesticide active substance mancozeb are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of mancozeb as a fungicide on wheat (winter/spring), grapevine, potatoes and tomatoes. The reliable end points, appropriate for use in regulatory risk assessment are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified.

We explore the spectrum of comorbidities in psoriatic arthritis (PsA) patients in comparison with other high comorbidity-burden diseases like rheumatoid arthritis (RA) and diabetes mellitus (DM).

Two hundred and fifteen PsA patients, cross-sectionally collected from two tertiary hospitals, were compared with 215 RA and 215 DM patients (age/sex-matched, similar disease duration). Cardiovascular risk factors [hypertension, current smoking, hyperlipidaemia, obesity (body mass index (BMI) ⩾30)], coronary artery disease (CAD), stroke, major adverse cardiac events (MACEs; combined CAD and stroke), depression, osteoporosis and malignancies were recorded. Odds ratios (ORs) for stroke, CAD and MACE were adjusted for age, sex, hypertension, smoking, hyperlipidaemia, BMI, glucocorticoids use and those for depression were adjusted for age, sex, disease duration, skin involvement and smoking. click here Within the PsA group, associations between comorbidities and demographic/clinical features were assessed.

Depression [OR (95%prevalent in PsA compared with RA and DM, while cardiovascular comorbidity was comparable to both groups, supporting the need for their assessment and management.

Depression was more prevalent in PsA compared with RA and DM, while cardiovascular comorbidity was comparable to both groups, supporting the need for their assessment and management.Spondyloarthritides (SpA) like psoriatic arthritis, axial spondyloarthritis/ankylosing spondylitis, reactive arthritis and inflammatory bowel disease (IBD)-associated SpA can present with characteristic skin manifestations. These SpA-associated skin disorders may precede joint involvement, reflect a loss of efficacy of a current systemic treatment or can even be treatment associated. Cutaneous manifestations in SpA not only add additional morbidity with physical impact but also impose a psychosocial burden on affected patients. Psoriasis (PsO) - the main skin disease in SpA - has a variety of clinical presentations, including plaque-type PsO, inverse PsO, guttate PsO, erythrodermic PsO, nail PsO and pustular types. SpA associated with IBD presents with neutrophilic and granulomatous skin disorders, including pyoderma gangrenosum, hidradenitis suppurativa and cutaneous Crohn's disease. Reactive arthritides has a favourable prognosis and may feature keratoderma blenorrhagicum or balanitis circinatum as typical skin manifestations. Immunologically, SpA-associated skin diseases share interleukin (IL)-17 and IL-23 dysregulation but show distinctive genetic and immunological profiles. Therefore, they vary in their treatment responses to targeted therapies with biologicals or small molecules. In this review, we highlight the clinical presentation of skin manifestations in SpA and discuss therapeutic approaches in this interdisciplinary field.

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